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Public Statements

Hearing Of The Health Subcommittee Of The House Energy And Commerce Committee - FDA Regulation Of Medical Devices


Location: Washington, DC

Chaired By: Representative Frank Pallone, Jr. (D-NJ)

Witnesses: Marcia Cross, Government Accountability Office; William Mazel, Director Medical Device Safety Institute, Department Of Medicine, Beth Israel Deaconness Medical Center; Philip J. Phillips, Independent Consultant; Peter Lurie, Deputy Director, Health Research Group

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REP. FRANK PALLONE, JR. (D-NJ): The meeting of the health subcommittee is called to order, and I'll recognize myself initially for an opening statement. Today the subcommittee is meeting to discuss the FDA's regulation of and authorities over medical devices. The goal of today's hearing is to determine if the current regulations are doing enough for patients while ensuring that these very important and sometimes lifesaving devices are truly safe and effective.

We are here to hear about where the current system works well and where shortfalls might be. There is evidence of an approval system that's broken, that its standards, its procedures and its rules don't meet modern needs of getting medical devices to those in need with confidence in their safety.

We have made huge advances in medicine over the last few decades. Many illnesses that were once a death sentence are now preventable, curable or at least manageable, through modern medical treatments. New and emerging technologies hold promises that our great grandparents could never have imagined, and the medical device industry is one of the main drivers of this progress.

From pacemakers to artificial hips to tongue depressors, we can't enter the health care system without coming into contact with these devices, and we need an approval process that keeps pace with new technologies, a modern process consistent with progress in medicine. We have to maintain the delicate balance between wanting to put these new technologies in the hands of patients who desperately need them and ensuring that the devices are actually safe for use in humans.

Now, last month this subcommittee held a hearing on the issue of pre-emption in the wake of the Regal versus Medtronic Supreme Court decision. The Supreme Court ruled that patients could not receive compensation for their injuries, medical expenses and lost wages caused by defective premarket approval, or PMA, devices or inadequate safety warnings. While state product liability provides incentives for companies to make safe products, it should not be the only tool we have to ensure that the medical devices that are on the market today are safe.

We need to know that the approval process and the regulatory standards are strong and enforceable and that the agency is empowered with the ability to ensure the safety of these products. It's the reason that we're here today at this hearing on the medical device approval process. I want a comprehensive overview of the major issues and potential problems that may arise in the regulation of medical devices. Of greatest importance to me is to find out what the FDA needs to ensure that the medical devices on the market are safe and effective.

In the FDA Amendment Act of 2007, I requested a GAO study to look specifically at the 510(k)process, and, in particular, focus on the pre-amendment devices that have never been through the FDA approval process. The GAO is here today and will talk about that report in more detail, and I'm interested to hear how the FDA is moving to review the high risk Class 3 devices that have yet to ever be approved formally, as Congress instructed the FDA to do in the Safe Medical Device Act of 1990.

Why has it taken so long for the FDA to act and what is the consequence of this inaction? Are there devices being cleared onto the marketplace that shouldn't be? But beyond this particular study, the GAO has written other reports on medical devices. These studies have highlighted some of the successes and possible failures in FDA's ability to properly assess the safety and effectiveness of devices, as well as maintain sufficient post-market surveillance and controls to ensure the devices patients are using continue to work the way they are supposed to.

And I'm looking forward to hearing more about these findings, as well. I also look forward to other witness testimony and hope that they give our committee members an in depth look into how the process is working and where it may need to be fixed, either through legislation or through increased and enhanced oversight at the FDA. At the end of the day, we're all talking about real people here, patients who need to know that these devices will do what they say that they're supposed to do and they won't cause them avoidable harm.

I want to thank particularly Dr. Marcia Cross from the GAO and her team's tireless efforts to ensure that we're responding to the needs of patients. And now I recognize Mr. Deal, our ranking member for an opening statement.

REP. NATHAN DEAL (R-GA): Thank you, Chairman Pallone. Thanks to our witnesses for being here today. Since we have several of you, I will not take too much time in my opening statement, but simply to reiterate that all of us, I think, share a concern that in this area of medical devices: that they be safe and that they do what they are supposed to do and that the approval process is adequate and that the approval process is not unduly delayed, so there is a delicate balance that has to be reached in terms of the approvals.

I'm especially concerned in light of what this committee has placed on the FDA in recent weeks from tobacco regulation to, yesterday, an enhanced food safety bill. All of us understand the importance of all of these areas and support it, but I think one of the critical questions that always has to be asked is, are we giving the FDA the resources and the abilities, legislatively or otherwise, to do what we're asking them to do?

Each of you share an insight into those questions, and I look forward to your testimony. I yield back my time. Thank you.

REP. PALLONE: Thank you, Mr. Deal. Next is our subcommittee vice chairman, Ms. Capps from California.

REP. LOIS CAPPS (D-CA): Thank you, Chairman Pallone, and we have great witnesses here, so I'll be brief, as well, but I'm very pleased and want to note that that we are holding this very important hearing today. I believe that members of Congress do have a duty to evaluate and reevaluate regulations to make sure that we are doing all we can to get safe and effective medical devices to American patients.

However, safety and effectiveness are not the only things we need to keep in mind as we consider these regulations.

We must also ask: do the rules in place pose any barriers to technological innovation, barriers that might hamper the improvement of prevention, diagnosis and treatment of disease? Ultimately, our evaluation must include assessing the premarket and post market processes for safety and effectiveness, as well.

The committee takes seriously our role in the oversight of that process. I'm eager to hear recommendations from our witnesses on what works, what doesn't, and how we can adequately address both. I yield back.

REP. PALLONE: Thank you. The gentleman from Indiana, Mr. Buyer. The gentleman from Georgia, Mr. Barrow. Gentleman from Pennsylvania, Mr. Pitts.

REP. JOSEPH R. PITTS (R-PA): Thank you. Thank you, Mr. Chairman. Thank you for convening this hearing. More than 8,000 new medical devices come to market in the U.S. each year, ranging from syringes and surgical gloves to pacemakers and heart valves. The Medical Device Amendments of 1976 gave FDA the responsibility of ensuring that medical devices are safe and effective, and provided a risk based framework for FDA to evaluate the wide variety of devices seeking approval.

The majority of Class 2 are moderate risk medical devices come to market through premarket notification, also known as the 510(k)process. Five ten (k) submission must demonstrate that the new device is substantially equivalent to one or more similar devices legally marketed in the U.S., and this excludes pre-1976 grandfathered medical devices. And the new device cannot be found substantially equivalent to a device that has been deemed misbranded or adulterated or removed from the market.

To be substantially equivalent, the product must be at least as safe and effective as the legally marketed or predicate device. It must have the same intended use and technological characteristics as the predicate or, if the intended use is the same but the technological characteristics differ, the technical differences must be shown to raise no new questions of safety and effectiveness.

510(k) submissions must include descriptive data or specifications, performance testing and, in approximately ten percent of cases, clinical data. The 510(k)process has evolved over the last 30 years and has served the American public well. It provides FDA the discretion and flexibility to apply the proper amount of oversight to each device submission. It provides for timely product review, and it encourages technological innovation and evolution of device technology.

GAO released a report in January of this year. It said, quote "The shortcomings in FDA's premarket review, post market surveillance and inspections of device manufacturing establishments -- " and I anticipate that Ms. Cross will have more to say on the matter, but I believe the criticisms outlined in the report have more to do with FDA's actions and inactions and its lack of resources than the statutory approval process for medical devices itself.

I look forward to hearing from the witnesses and thank you and yield back my time.

REP. PALLONE: Thank you, Mr. Pitts. Chairman Dingell.

REP. JOHN D. DINGELL (D-MI): Mr. Chairman, good morning. Thank you for holding this hearing on the current state of medical device regulation. And I want to thank today's witnesses and look forward to their informative testimony. I also want to thank you for yesterday's work and my colleagues on the committee for what we did with regard to Food and Drug in the area of foods. This is a worthy successor for that undertaking, and I'm delighted to see the way that you are leading on this matter.

It is very important to address the concerns that are developing with regard to the balance the responsibilities of Food and Drug on pharmaceuticals, cosmetics and devices. In response to the question that you proposed in the title of this hearing, I am convinced that more could be done to protect patients. This year alone there have been nine Class 1 recalls of medical devices. It is to be noted that these recalls are occurring in a very badly staffed, indeed understaffed, agency without the resources to properly monitor it's responsibilities.

Class 1 recalls, as we know, are the most serious type of recall and involve situations in which there is reasonable probability that use of these products will cause serious injury or death. I would note that the device industry is a responsible institution and is composed of responsible people. And I know they will want to work with us to make progress in terms of assuring safety of the American consumers and that competition in that particular portion of the medical services industry is conducted in a way which does not constitute a race to the bottom.

In examining the regulatory framework that we currently confront for medical device approval, a few questions come to mind. First, is the current medical device approval standard quote "reasonable assurance of safety and effectiveness," close quote, rigorous enough? Second, does FDA rely on quality clinical studies during the medical device approval process? Third, is the current 510(k)review able to adequately ensure that devices that are marketed through this abbreviated approval process are safe and are being handled in a way consistent with the public interest?

Last, is there too much discretion allowed to FDA in determining whether, through the 510(k)process new device has the quote "same intended use" close quote or whether it has different technological characteristics. This is a matter of no small importance.

FDA premarket notification process for medical devices has been in place since 1976. Low risk and moderate risk devices are subject to abbreviated 510(k)process. With some exceptions, high risk devices require premarket approval, a PMA process. Devices that were on the market prior to the Medical Device Amendments, MDA, were allowed to remain on the market with the assumption that FDA would later determine the product safety.

We need to know whether this has been done, and I don't think anybody can answer that question at this particular time. Unfortunately, it appears that many of these products did not undergo rigorous review mechanisms and, unfortunately, we have other devices coming on the market using pre-MDA devices as a reference device.

That is something that imposes substantial risk and peril on American consumers. I also have concerns with the frequency of inspection of medical device establishments, and this is something we ought to listen to carefully. GAO estimated the FDA inspects foreign manufacturers of modest risk devices only once every 27 years and foreign high risk manufacturers every six years. Despite the fact that there are more registered device manufacturers in China than any other foreign countries -- (sic)--, Chinese firms—listen to this—can expect the FDA to visit them only once every 50 years. I don't think anyone in this room can find that to be acceptable.

Yesterday, we were pleased that this committee unanimously passed the Food Safety Enhancement Act in a bipartisan fashion, which will give FDA greater authorities and resources to protect our food supply. I intend to build on this bipartisan success as we turn our next focus to medical devices and pharmaceuticals.

As you know, we worked on this matter in a bipartisan way and we worked cooperatively with the industry. And I call on all of my colleagues to show the same extraordinary cooperation they did while we worked on this legislation and also on the industry to understand that we seek to see to it that they prosper, but at the same time that the consumers are protected. And we hope they'll have their help.

Mr. Chairman, the FDA Globalization Act of 2009, legislation that you and I introduced earlier this year, will provide a solid foundation as we move forward to addressing the safety of medical devices, and I will add, also, safety of pharmaceuticals and cosmetics.

I want to thank the witnesses for joining us today as we take a close look at this important topic. I want to thank you, Mr. Chairman, and I want to thank my colleagues for the good work we did yesterday. And I want you to know I look forward to working with all of you to try and see to it that we carry forward for the protection of the American consumers on the balance of Food and Drug's rather shabbily handled and rather underfinanced resources and efforts. Thank you, Mr. Chairman.

REP. PALLONE: Thank you, Chairman Dingell, and thank you for all you've done on this issue and others. Next is the gentleman from Texas, Mr. Burgess.

REP. MICHAEL C. BURGESS (R-TX): Thank you, Mr. Chairman.

It is my firm opinion that this hearing should be about science and solutions, so I would just simply ask the question: where is the Food and Drug Administration today? The Food and Drug Administration regulates more than 100,000 different medical devices manufactured by more than 15,000 companies. This number represents a spectrum of devices from all three medical device regulatory classes, as defined by the Medical Device Amendments of 1976.

Now, as often as I complain about how many times the Food and Drug Administration appears before the Energy and Commerce Committee and it is no small investment of their funds that when we bring them up here, my complaint is aimed at wasting the Food and Drug administration's resources to continue to answer questions about competence when it is clear that resources are the real remedy. If we are going to gavel in a hearing merely looking for a solution to any real or perceived gaps in the medical device approval process, then clearly I think we need to hear from the Commissioner of the Food and Drug Administration, or their surrogate, so they can inform us what tools they need to address any gaps in regulatory authority to continue to ensure the safety of medical devices for all Americans.

When informed of the use and possible misuse of the 510(k) process, the previous Commissioner of the Food & Drug Administration, Dr. Andrew von Eschenbach, dramatically stated that the 510(k) system is quote "out of control," close quote. Has the approval process simply improved with the change of administration or are there still lingering issues? That is why we should have the presence of the Food & Drug Administration here today.

I'm also noticing a troubling trend in our conversation about both devices and drugs. Last week we held a hearing on biosimilars and did we have the Food & Drug Administration present? No. We had the Federal Trade Commission. Now, I'd like to think that's merely an oversight, but a pattern does seem to be developing which I think we should stop.

The Food & Drug Administration is not immune from interference. In the 1990s, it was noted that the Food & Drug Administration took too long to approve devices, and we may have the opposite situation now. And none of us must forget that speed sometimes kills. The evidence points to the problem lying in the exceptions process to the device approval known as the 510(k) application, which the Food & Drug Administration will grant for those devices which have substantial equivalents on the market.

We want ingenuity and creativity in the marketplace and we don't want the government to stand in the way of that process, but safety must always be our foremost concern. If safety is compromised, patients will never seek out the treatment which these devices—and I will tell you, as a practicing physician for over 25 years, in today's medical/legal climate no doctor wants to place or implant a device which would be less than safe.

This is why the premarket approval process, as lengthy and arduous as it is, should not be overturned simply because the process is long. Safety cannot be timed. The device approval process is long for a reason. The science must rise to the level of trust Americans place in the stamp which says "Approved by the Food & Drug Administration."

There are questions that need to be answered, Mr. Chairman, which only the Food & Drug Administration can answer, and I hope we will take careful consideration of what the Food & Drug Administration has to say before we enact any laws or make changes to current authority. I will yield back the balance of my time.

REP. PALLONE: Thank you. Next is the gentlewoman from the Virgin Islands, Ms. Christensen.

REP. DONNA M. CHRISTENSEN (D-VI): Thank you, Mr. Chairman. The approval process for medical devices is an important issue, and I thank you, Chairman Pallone, for holding this follow-up hearing on it. Any concerns with the approval application process need to be resolved so that we can continue to bring these lifesaving products quickly and safely to the American public. In the practice of medicine, we're always taught to weigh the benefits of treatment versus the risks.

And while this is true for devices as well as for pharmaceuticals, the approach to approval both in the primary product and the secondary one, trying to use the pharmaceutical model for medical devices is perhaps worse than comparing apples to oranges and, in my opinion, should be avoided. I also think it's important to recognize that we're having this hearing as we're emerging from the previous administration and that today we're in a different administration, a different place, a different mindset, a different vision.

Between 2001 and 2009, we watched scientists and sound science be replaced or significantly influenced by industry special interests and political and even religious ideologues on several scientific panels. And it's my sense, from previous hearings and the examples raised in testimony, that the problem has not been so much the use of the 510(k) application process but the failure to adhere to the process and the dictates of sound science.

Also, from what I've read thus far, what I've seen is that there's a backlog in the work that FDA is already authorized and required to do. I'm sure that does have something to do with prior staffing and funding levels. There may be some minor fixing of the medical device approval process that needs to be done, but, for the most part, it seems sound. And if we adhere to science and use what's already provided for in the process, I think we'll successfully protect the public's health and safety.

I look forward to the testimony and the dialogue with our panelists. Thank you. I yield back.

REP. PALLONE: Thank you. Gentleman from Georgia, Mr. Gingrey.

REP. PHIL GINGREY (R-GA): Thank you, Mr. Chairman. Today, as a result of advances in medical technology, we Americans enjoy access to a quality of healthcare that most nations do not. While some countries restrict or ration the types or amounts of drugs and devices the patients can access, American patients can receive the latest, the most advanced, medical technology, such as an artificial hip or a knee or the latest cancer medication that will drastically improve and extend their lives.

My 91-year-old mother, for an example, recently had knee replacement surgery, and her quality of life has been dramatically improved over the last several months because of this surgery. Mr. Chairman, ensuring the safety of medical devices is an absolute necessity for our continued access to quality health care.

The FDA is charged with making certain that all medical devices have been thoroughly tested for safety and effectiveness before coming to the market. It is one of the FDA's primary responsibilities, and I support increased efforts in this area. Unfortunately, there is an inherent risk associated with most modern medical procedures regardless of advances in technology or, indeed, effective oversight. It goes without saying that there are few absolutes in this world.

Mr. Chairman, I'm especially concerned with the GAO report submitted for testimony today. The report, citing an FDA report in 2006, that cites quote, "The agency's ability to understand the risks related to the use of medical devices is limited by the fact that the volume of submitted reports exceeded the FDA's ability to consistently enter or review the reports in a routine manner," end quote.

We have spent a few months in this committee examining ways to expand FDA's oversight of tobacco, a product that is, by all accounts, outside of the agency's core mission, or it was. This new authority will further burden an agency that by GAO standards has had shortcoming in other areas of its current oversight responsibilities.

With this thought in mind, I'll look forward, of course, to hearing the testimonies of our witnesses today. Mr. Chairman, I thank you for calling the hearing and, with that, I'll yield back my time.

REP. PALLONE: Thank you, Mr. Gingrey. The gentleman from Ohio, Mr. Space.

REP. ZACHARY T. SPACE (D-OH): Thank you, Mr. Chairman. Very briefly, I appreciate your calling this hearing on what is obviously a very important issue, the safety of medical devices available on the market, and I look forward to working with the committee as we continue to -- (off mike) -- system that ensures that our consumers are safe while creating avenues for innovation and avenues to help consumers with their illnesses and inflictions and to strike that proper balance.

I look forward to the testimony and, once again, thank you and Chairman Dingell for your work on this issue.

REP. PALLONE: Thank you. Gentleman from Connecticut, Mr. Murphy.

REP. CHRISTOPHER S. MURPHY (D-CT): Thank you, Mr. Chairman. I'm looking forward to today's hearing as a new member of this subcommittee and, in particular, I'm looking forward to getting a better understanding, particularly from our friends at the GAO, what they found as it relates to the FDA's current authorities to regulate varying classes of devices.

Importantly, I believe we must determine whether the current processes at FDA uses the 510(k) process and the PMA processes are adequate in their design but have been flawed in how aggressively the FDA uses its authority or if the processes themselves need to be updated. Often, what Congress has found in a number of areas is that the regulations we intend and pass are only as good as the regulators and the agencies that are meant to enforce them. With a new administration in office, I believe that it is important, going forward, to hear from them directly about their intentions as it relates to these processes and how they intend, if at all, to enforce current regulations differently than their predecessors.

Again, Mr. Chairman, I thank you very much for convening this hearing, which is fundamentally about patient safety and improving our response to that but also about sustaining important advances in medical technology. I yield back the balance of my time.

REP. PALLONE: Thank you, gentleman from Texas, Mr. Green recognized for an opening statement.

REP. GENE GREEN (D-TX): Mr. Chairman, I want to thank you for holding the hearing on the regulation of medical device safety. In 1976, the FDA was given the authority to regulate medical devices by Congress. Congress directed the FDA to characterize devices into three categories: Class 1, Class 2, and Class 3.

In order for a manufacturer to market a device for sale and use, they must demonstrate to the FDA that the device is safe and effective for its intended use. The manufacturers can do this in their premarket application process or a process which is known as 510(k) clearance processes. Five ten (k) clearance is used to bring devices to market that are substantially equivalent to a previous device that the FDA has already cleared for marketing.

The premarket application process is more stringent than the 510(k) process. The premarket application can require clinical trials to demonstrate the safety of the device. Much has been said by this committee over the past year with regard to safety and monitoring of our food and drug systems at the FDA. I could argue that the device -- (off mike)— FDA has a good system in place to monitor the safety of medical devices compared to food and drugs.

This is one of the few sectors of the FDA that has the ability to issue mandatory recalls in the instance of an adverse event and they can require the reporting of adverse events by hospitals, nursing homes and clinical labs. Additionally, the FDA requires manufacturers to identify and monitor significant adverse events in the manufacture and user facility device experience database.

I'm looking forward to hearing from the witnesses today on the current state of the medical device safety at the FDA. I would also like to say we have a new FDA commissioner, and I'm sure the new team at the FDA will be making some changes in all sectors of the FDA. I would think we could identify the issues in this hearing today that need to be addressed, and I hope this new team will certainly consider it.

And, again, thank you for the hearing. I yield back my time.

REP. PALLONE: Thank you, Mr. Green. The gentleman from Maryland, Mr. Sarbanes.

REP. JOHN P. SARBANES (D-MD): Thank you, Mr. Chairman. I'm looking forward to the testimony here today from the panel. This is another hearing that goes under the heading of the FDA is back or the FDA is coming back, however you want to look at it. We've had a number of hearings and markups of legislation designed to make sure that the FDA has the sufficient regulator authority it needs to ensure that Americans have the confidence that these kinds of devices are safe and other things that are safe. That's essentially all the average person is looking for, that government is looking out for them in the way that they expect.

I've been impressed, I guess is the word, maybe struck, by discovering the things that the average person out there would assume are in place are not in place, so a lot of what we're doing is getting back to meeting the expectation of the consumer out there, that these protections are available, so this hearing, as others have done, is looking at whether there's, as I said, the sufficient regulator authority, whether the resources are in place at the FDA to do the job that they need to do, whether the talent is there.

I believe that talent pool is becoming deeper and deeper by the day, and whether this attitude of vigilance that needs to be part of the agency's approach is in place, so we're very encouraged by the direction things are moving and your testimony today will help shed even further light on that.

And I yield back my time.

REP. PALLONE: Thank you. Gentlewoman from Florida, Ms. Castor.

REP. KATHY CASTOR (D-FL): Thank you, Mr. Chairman, very much for calling this important hearing on medical devices and the FDA. In reading the GAO report on the current status of the FDA regulation of medical devices, I'm concerned about the efficacy of the practices used to approve devices, particularly those that may impose life or death consequences on the patients that use them. I'm also concerned that the FDA has thus far been unable to implement the more stringent premarket review of certain devices, as intended by the 1976 law.

FDA has not been able to review all of the reports of adverse events caused by devices released into the market, and this lack of oversight in the market poses a heightened risk for consumers. Now, Americans certainly appreciate the lifesaving medical devices and the great innovation over the past decades, but with these innovations we've seen many more advanced products entering the market that require scrutiny and attention. And while we want to ensure that product review is completed in a timely manner, we do not want to allow under reviewed devices into the market that may impose risks that could be avoided with a more responsible review.

Thank you to the witnesses for being here today. I look forward to your testimony and recommendations. I yield back.

REP. PALLONE: Thank you. The gentleman from Iowa, Mr. Braley:

REP. BRUCE L. BRALEY (D-IA): Thank you, Mr. Chairman, for holding this hearing on medical device regulations. The safety of American patients is a matter of utmost importance to me and every member of this committee, and the issue before us today is truly a matter of life and death. The January 2009 GAO study of the 510(k) premarket notification process was eye-opening, to say the least. As many here are aware, the report made the recommendation that the FDA expeditiously take steps to issue regulations for Class 3 device types currently allowed to enter the market through the 510(k) process by requiring premarket approval or reclassifying them to a lower class.

It's astonishing to me that the 94th Congress envisioned that the FDA would approve Class 3 devices through the PMA process and here we sit, in the 111th Congress, wondering why this hasn't happened. Since the GAO report, FDA did take the step of requesting information on the safety and effectiveness of these devices. However, there are few details available and no timeframe that I'm aware of outlining FDA's next steps to help ensure the safety of those devices. In addition, it's my understanding that the FDA has struggled with its post market surveillance of devices and it is not meeting statutory requirements for inspecting certain manufacturers.

This is not a good record of oversight of medical devices by the FDA. Amazingly, despite the limitations on FDA's ability to keep Americans safe, we have seen other efforts here in Washington undermine the only other check on the safety of medical devices, judicial recourse for injured patients.

(Off mike.)

REP. PALLONE: Gentlemen, I'm just afraid your mike is not on and the reporter----what's going on? Is it—did you press the button? It's not working?

(Off mike.)

REP. PALLONE: Does that mean you can't record it or—

(Off mike.)

REP. PALLONE: Do you want to move to another—we don't want you not to be recorded.

REP. BRALEY: Where would you like me to be at? Do you want me to start over? I apologize to everyone in the room for having to go through this again.


REP. BRALEY: Thank you, Mr. Chairman for holding the hearing today on medical device regulations.

REP. PALLONE: You can just continue from where you were.

REP. BRALEY: All right. I think where I was right at the time of the interruption was talking about the importance of maintaining our complimentary system of accountability to protect consumers through both the FDA and American courts. Those who oppose ensuring patient safety through judicial accountability often make the argument that FDA approval of a medical device is enough to ensure the safety of the device.

Yet here we sit in a hearing about FDA shortcomings and the evidence is clear that we should not be betting lives on the efficacy of the FDA. That's why, in addition to ensuring a stringent medical device approval process through the FDA, we must pass H.R. 1346, the Medical Device Safety Act. This legislation is needed to ensure that every American patient has the ability to hold manufacturers of defective medical devices accountable for injuries and deaths caused by unsafe products.

And, yes, many of these unsafe products did receive FDA approval, yet still resulted in recalls, injuries and deaths. The Medical Device Safety Act clarifies the intention of Congress to keep American patients safe by maintaining our complimentary systems to protect patients through the FDA and American courts. Many medical safety experts agree that patient safety is compromised when we allow the FDA to have the final say on device safety and the examination today of the FDA shortcomings is only further evidence of this.

Strong state laws are critical to maintaining accountability for device manufacturers and allowing the FDA to preempt these state laws is a sure-fire way to place sales over safety and profits over people. When it comes to patient safety, we must not lose sight of the fact that the single most important priority that all of us share is saving lives.

So, thank you, Mr. Chairman, for holding the hearing. I thank the witnesses and my colleagues in the audience here today for recognizing the importance that this issue has on individual American's health and safety.

REP. PALLONE: Thank you, and I'd ask the unanimous consent that Mr. Braley's entire statement be included in the record. Without objection, so ordered. And I believe that concludes our opening statements by members of this subcommittee so we'll now turn to our witnesses, and I obviously want to welcome all of you.

Let me introduce each of you. Starting on my left is Dr. Marcia Cross, who is with the GAO. I don't have your title? What is your title?

MS. CROSS: Director of Health Care.

REP. PALLONE: Director of Health Care. Okay, thanks, and then we have Dr. William Mazel, who is Director of the Medical Device Safety Institute, Department of Medicine at Beth Israel Deaconess Medical Center in Boston and, also, Harvard University, I believe. And then we have Philip J. Phillips, who is a independent consultant and Dr. Peter Lurie, who is Deputy Director Health Research Group for Public Citizen.

And we usually, what we do is, we have five minute opening statements. I think you know that. They become part of the hearing record and then we may give you some written questions afterwards, hopefully within ten days after the hearing, that we would ask you to respond to as well. And I'll start with Dr. Cross.

MS. CROSS: Mr. Chairman and members of the subcommittee, I'm pleased to be here today as you consider issues related to the regulation of medical devices. Americans depend on FDA to provide assurance that medical devices sold in the United States are safe and effective. FDA's responsibilities span premarket review of devices, post market surveillance and inspections of manufacturing establishments.

We've done work to examine aspects of all these areas and have identified a number of concerns and made recommendations for improvements. Earlier this year, GAO added FDA's oversight of medical products, including medical devices, to its list of high-risk areas warranting attention by Congress and the Executive Branch. Today I will provide some general background and touch on the findings from a number of GAO reports.

As you know, FDA classifies medical devices into three classes, with Class 1 including devices with low risk to patients, such as bandages, and Class 3 including devices with high risk, such as pacemakers. About two-thirds of medical devices are exempt from any FDA-premarket review. These are mostly low risk Class 1 devices and some Class 2 devices. FDA does little to monitor these devices, including rarely inspecting their manufacturing facilities.

I will focus my remarks on the remaining one-third of devices, which require greater regulation and oversight. Almost all of these devices, mostly Class 2, are reviewed by FDA through its premarket notification process, known as the 510(k)process. The remaining one percent of medical devices are Class 3 devices that are subject to FDA's premarket approval or PMA process.

Medical device regulation follows a least burdensome approach. The 510(k)is less stringent than the PMA process. For 510(k)submissions, the manufacturer must demonstrate that the new device is substantially equivalent to a device legally on the market. Clinical data are generally not required and substantial equivalents will normally be determined based on comparative device descriptions, including performance data. For the more stringent PMA process, the manufacturer must supply evidence providing reasonable assurance that the device is safe and effective.

Manufacturers typically submit clinical data for a PMA application, but FDA does not always require clinical data even for implantable devices. FDA may approve a Class 3 device solely on the basis of engineering data. FDA clears, or approves, the vast majority of both 510(k)and PMA submissions. Some 90 percent of the Class 1 and Class 2 510(k) submissions are cleared for marketing, and roughly 80 percent of PMA applications for Class 3 devices are approved by FDA.

In January 2009, we reported on a key area of concern regarding FDA's premarket reviews. When Congress established FDA's premarket review system for medical devices in 1976, it envisioned that all Class 3 devices would be subject to the more stringent PMA process. Nonetheless, we found that more than 30 years after Congress acted, FDA had still not completed the regulatory steps necessary to require PMA reviews for some two dozen types of Class 3 devices, including certain hip joints and other implantable devices.

In the five-year period we reviewed, almost one-quarter of the Class 3 device submissions that were cleared went through the less stringent 510(k)process. We recommended that FDA move expeditiously to address this issue and, in response, in April of 2009, FDA began the necessary steps. However, the agency has not specified a timeframe for how quickly it will act on these devices.

The least burdensome approach relies on post market studies to identify problems. However, FDA also faces challenges in post market surveillance of medical devices.

For example, the agency's ability to understand the risks related to the use of medical devices is limited because the volume of adverse event reports submitted has exceeded FDA's ability to consistently review the reports.

We've also found shortcomings in FDA's monitoring of manufacturers' compliance with post market study and reporting requirements. Finally, we found that FDA has not conducted required inspections of manufacturing establishments, which are FDA's primary means of assuring that the safety and effectiveness of devices are not jeopardized by poor manufacturing practices. In 2008, we reported that FDA has not inspected domestic establishments on schedule and inspections of foreign establishments greatly lag domestic inspections.

FDA has begun to take steps to address shortcomings related to inspections, including opening foreign offices and hiring additional inspectors. However, FDA has stated that it will be several years before inspectors are sufficiently trained to conduct foreign inspections. Taken together, our work raises concerns about the current premarket and post market activities that are necessary for ensuring the safety and effectiveness of medical devices.

Mr. Chairman, this concludes my prepared remarks. I would be happy to answer any questions that you, or other members of the subcommittee, may have.

REP. PALLONE: Thank you, Dr. Cross. Dr. Mazel.

DR. MAZEL: Thank you, Chairman Pallone, Ranking Member Deal, distinguished members of the committee. My name is Dr. William Mazel. I am a practicing cardiologist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School in Boston. I also direct a Medical Device Safety Institute, an industry independent non-profit organization dedicated to improving the safety of medical devices.

I have served as a consultant to the FDA's Center for Devices and Radiologic Health since 2003, and I have previously chaired the FDA's post market and heart device advisory panels. Thank you for the opportunity today to speak about medical device regulation and to discuss areas where improvements can be made to the benefit of millions of Americans who utilize medical devices every day.

Recently, several high profile device safety issues have raised concerns about the FDA's ability to properly evaluate and monitor the safety and effectiveness of medical devices. FDA has been criticized for taking too long to identify medical device safety concerns and for failing to implement robust scientific standards for device clearance and approval.

FDA device physicians and scientists have alleged serious wrongdoing at FDA, including the alteration and distortion of scientific and technological findings and conclusions. Unfortunately, these allegations divert attention from the many superb FDA engineers, physicians, scientists and public servants who work tirelessly to ensure that only safe and effective medical devices reach the American public.

We are fortunate to have the pre-eminent medical device regulatory system in the world. The U.S. Food & Drug Administration regulates more than 100,000 different medical devices manufactured by more than 15,000 companies. They annually receive several thousand applications for new and modified devices and they are mandated by Congress to complete their pre-market evaluations in a timely fashion.

Unlike drugs, the medical device product life cycle from conception to obsolescence is short. While a drug may remain on the market essentially unaltered for decades, rapid technological device advances offer the potential to improve medical device performance, reduce patient suffering, improve health and, sometimes, treat previously untreatable conditions. Unnecessarily slowing the device regulatory approval process would be akin to leaving medical device patients with an outdated, antique telephone in an iPhone world.

Nevertheless, it is evident that to best protect the health of American medical device users, the FDA must promote and enforce a higher scientific standard for device clearance and approval, particularly for higher risk devices whose abnormal performance is likely to have adverse effects on patient health. Unfortunately, due to the current FDA premarket evaluation process, unanswered questions regarding device safety and effectiveness often remain at the time of FDA clearance or approval. This creates the potential for a large number of patients to be rapidly exposed to a newly approved product in the absence of long-term follow-up data.

For example, close to 268,000 people had been implanted with the Medtronics (sic) spring fidelis implanter defibrillator lead before it was recalled in October 2007, after it was determined that the wire was prone to fracture. A fracture of the lead which connects the implantable defibrillator to the heart may result in serious health consequences, including painful electrical shocks or death.

Mr. Sidney Engler, a patient of mine, was one of the unfortunate people to receive this lead when he had an implantable defibrillator placed in February 2006. Mr. Engler is a decorated World War II veteran, having served in Europe from 1943 to 1945, and on the evening of August 14th, 2008, while preparing to retire for the evening, the simple act of removing his shirt over his head caused his defective defibrillator lead to fracture. Mr. Engler suffered a cardiac arrest in front of his wife. He required CPR and received numerous unnecessary painful shocks from his defibrillator.

Fortunately, due to the prompt response of his local EMTs, Sidney survived. Despite a prolonged hospital stay and months of rehabilitation, he is still not fully recovered. The FDA approved the Medtronic's (sic) spring fidelis implantable defibrillator lead, the one in Mr. Engler's heart, as a PMA supplement in 2004, on the basis of no human clinical data.

The original Medtronic defibrillator PMA was submitted in 1992. More than 30 supplements had been submitted in the interim and the fidelis lead bears little resemblance to its original counterpart. In addition to a lack of human clinical performance data, the FDA failed to require a post market study to monitor the device's performance. The result was the widespread distribution of a defective product to hundreds of thousands of patients.

Medical devices have enriched and extended the lives of countless people. The safety and performance of medical devices must be improved and the frequency of medical device malfunctions and adverse events must be reduced. Additional consumer safeguards are needed. By demanding more thorough scientific device evaluations, the FDA can reestablish consumer confidence and improve its ability to protect the public's health. Thank you.

REP. PALLONE: Thank you, Dr. Mazel. Mr. Phillips.

MR. PHILLIPS: Mr. Chairman, Mr. Ranking Member and subcommittee members, thank you for the opportunity to share my testimony with the subcommittee today. For the record, I'm here as an independent consultant. I'm not representing any companies, trade associations or any special interest, and I've received no compensation from any source connected with anything related to my appearance today. As I understand it, I'm here simply to express my views on FDA regulation of devices based upon my 28 years of experience dealing with the regulation of medical devices.

Twenty-four years of that was with the Food & Drug Administration and since then I've had four years with the private sector. Keep in mind it was just a mere 33 years ago that devices were not subject to the regulations that they are subject to today. There was no FDA premarket authorization 33 years ago. No premarket authorization, registration listing, GMP inspections, and there was very little post market surveillance or post market vigilance.

The 94th Congress did, actually, a remarkable job in designing the medical device amendments of 1976. They created a three-tiered classification system for medical devices where the level of FDA regulation is commensurate with the risks associated with the devices. The system appears complex, but from my vantage point, it's actually very simple. Under the 1976 authorities, the simplest of devices were placed into Class 1, subject to general controls. General controls include prohibitions against adulteration, misbranding, good manufacturing practices, labeling, registration and listing, and a few others.

Devices that were of greater complexity were put into Class 2, subject to, at that time, it was required to be performance standards.

The distinction between Class 2 and Class 3 devices was that the agency had confidence that they knew sufficiently enough about the technologies and the use to conclude that performance standards could be developed to assure safety and effectiveness. The most complicated devices or complex devices, the higher risk devices, where they did not have the confidence of general controls and special controls to assure safety and effectiveness, were to be placed into premarket approval where a device by device demonstration of safety and effectiveness would be required.

Lastly, under the medical device authorities, Congress provided the agency the ability to adjust classification over time based upon the experience and knowledge gained from the use of medical devices, and that was through reclassification processes. Initially, there were 16 expert advisory panels that looked at over 1,600 generic types of devices. A generic type of device could include dozens of manufacturers and literally hundreds of individual models, not to mention components and accessories.

The recommendations of these committees fueled the rulemaking process and FDA-generated classification regulations for each and every one of these generic types of devices. Today I believe that there are --- (inaudible) -- generic types of classification regulations in the Code of Federal Regulations. The original framework exists, although they expanded to accommodate the diverse nature of medical technologies and also the rapidly advancing technology.

What is a 510(k)? We've all talked about 510(k). It is a means for FDA to classify devices. It's not an approval. In fact, there's a prohibition for industry to refer to a clearance through a 510(k) as an approval of a device. But devices found substantially equivalent could go to market subject to the requirements that are associated with the generic class in which they are assigned.

In 1981, I was a review scientist with FDA. I can remember my first five 510(k)s. I looked at them; they were very simple submissions. We did side-by-side comparisons of descriptive data: one device versus an old device. It was actually very simple in the earlier days, but, as technology evolved, we realized we had to have a greater framework and structure in which to render substantial equivalents to terminations. Today's 510(k)s are replete with performance data on the new devices.

Simply examine any 510(k) or look at FDA guidance document, and you'll see what FDA's scientific expectations are for new devices. Reviewers get largely what they demand and, again, simply look at the number of additional information requests and look at the responses. You'll find industry provides the reviewers exactly what they need in order to be able to support their clearances.

The PMA process is very rigorous and demanding. It's not only high standards to get to market, but it's almost like a mortgage on a home. Once you're successful and you get your PMA application, it is actually a significant burden to stay on the market because of the filing of voluminous reports and supplements to the Food & Drug Administration.

It's sort of an interesting dichotomy that I'll bring to your attention because innovations come from generally small, entrepreneurial companies, and those are the least able to comply with the rigorous PMA requirements. With rare exception, only the large companies are able to play in the PMA arena.

My bottom line is, I think that there's a place for the PMA process, and it should be used whenever it is warranted.

As far as my recommendations, I'll leave you with just simply four. We have new administration at the Food & Drug Administration, and I think that we should empower Dr. Hamburg and Dr. Sharpstein to look at the medical device program, identify any gaps that exist, and formulate a strategy for dealing with those gaps.

For Class 3 devices, I agree completely with the General Accounting Office. They need to be dealt with, either through reclassification or premarket approval, one or the other.

There's another interesting issue that I'll bring to your attention, which I think is also a gap that is a deficit in the way that devices are regulated. For Class 2 devices, they were supposed to be performance standards. The agency has never promulgated performance standards. Actually, one dealing with the safety of leads associated with electrical products that come -- (off mike) -- with patients, but, by and large, there's no performance standards and there are a relatively small number of special controls.

Special controls replaced performance standards with the Safe Medical Devices Act of 1990. I believe that the agency should develop special controls for everything that's in Class 3, just like there should be premarket approval for everything that, excuse me, there should be special controls for everything in Class 2 just like there should be premarket approval for every Class 3 medical device.

The last thing I'll say is that the reclassification process needs to be vitalized, not revitalized because it has never been a really functional system. The agency and consumers need to have the ability to adjust the classification of devices based upon new information.

With that, that's the end of my remarks, and I look forward to questions.

REP. PALLONE: Thank you, Mr. Phillips. Now let me just -- I want to hear from Dr. Lurie and we will right now, but I did want to mention, unfortunately, that that bell was for 28 amendments that we will be voting on, so we're going to hear from Dr. Lurie, then we're going to go to the floor. It says right now that the first is 15 minutes and each of them are five. I'm hoping that when we get there, they'll reduce it to two, but we're talking probably at least an hour and a half, so we're going to hear from Dr. Lurie and then we'll go vote, hopefully be back by around noon, maybe earlier. I doubt it, and then we'll take questions. So, Dr. Lurie—

MR. LURIE: Chairman Pallone, members of the committee, thank you for the opportunity to address you. Our comments this morning are primarily about the premarket review of medical devices and not about post market issues at all. I can summarize my comments as follows.

The bad news is that device review, particularly with respect to effectiveness at the FDA, is severely damaged. But the good news is that actions at the FDA could take today, without any additional regulatory or statutorial authority in addition to powers that could be granted by this committee and by the full Congress, could make an enormous difference in improving the quality of medical device review.

We're going to look at three separate problems in medical device review and I'll give examples from recent regulatory proceedings to illustrate each of those. Problem one: the standard for approval of medical devices is lower than the standard of approval for drugs. By statute, the approval standard for drugs is quote "substantial evidence of effectiveness," whereas the sponsor of a new device need only demonstrate quote "a reasonable assurance of safety and effectiveness." What this means is that, whereas you might get two clinical trials for a drug to be approved, a single study, if you even get that, is the norm for devices.

In fact, FDA regulations even permit the absence of well- controlled investigations under PMA. In practice, for consumers, what this means is that data that would never be considered sufficient to support the approval of a drug can result in the approval of a device and, thus, to treat the very same condition, as my example will show, that's potentially diverting patients from effective and well-proven drugs to less effective and less well-proven devices.

Consider the Cyberonics vagus nerve stimulator. It's a surgically implanted device for depression. A randomized control trial was done, and it failed to demonstrate any significant impact upon depression. However, the company was allowed to rely upon the kind of data that the drug division at the FDA would not even look at. They were allowed to look at follow-up data at a year, using a control group that was not randomized, it was not blinded, using patients that were recruited at different times, and in which the patients were allowed to modify their antidepressant drugs and even get electroshock therapy. An expert at the FDA's drug center told the device center that with similar data for an antidepressant drug, the drug center would not even have allowed the filing of a NDA.

Yet, instead, what happened was, the Center for Devices Director consulted with more than 20 FDA scientists and officials, not one of whom recommended approval of the device, and he overruled all of them, and the product got approved.

Fortunately, CMS has taken the position that the product is, in effect, not effective and is not reimbursing, so it's not been widely used.

Now, the second two problems that I want to talk about deal with the 510(k), and we've already heard a lot about them. We've heard already how, according to the GAO, the 510(k) process is generally a stringent, expensive and -- (inaudible). We've heard how only a small minority of 510(k) submissions contain any clinical data. In fact, the FDA says, quote "it does not attempt to address all of the issues that would be answered in a PMA in it's review of 510(k)s."

Now the 510(k) pathway itself is not the problem. The problem is that there are two ways to get into the 510(k) process and in practice, in part because of legislation and in part because of FDA practice, these are not interpreted in a rigorous way and so products that ought to be going through PMA instead go through 510(k)

So that leads to problem two: the permissive interpretation of same intended use. That's one of the two elements that can get you into 510(k). The best example here is ReGen's Menaflex Collagen Scaffold, which is a device implanted during arthroscopic surgery to replace damaged knee cartilage. Now after consulting with the FDA, ReGen began a trial to support a PMA, which was a well-done, two-year, randomized trial comparing partial meniscus removal to partial meniscus removal with a product, the MCS.

The only problem was, this study was stone-cold negative. Absolutely no evidence of benefit whatsoever. Now, after the trial was complete, the FDA allowed the company to shift courses and submit a 510(k). Why were they able to do this? Because current agency practices provide for permissive interpretations of "same intended use." They say, quote, "our scientific expertise enables us to exercise considerable discretion in construing intended uses."

Now, the first two 510(k)s were rejected, and in a third one, ReGen said that the predicate device, the device to which it needs to be shown to be substantially similar, was surgical meshes, surgical meshes that do not plainly seem to be for the same intended use at all -- rotator cuff mesh in the shoulder, anal fistula plug, and hernia repair graft. These don't sound like devices that belong in the knee. However, in fact, an FDA reviewer pointed out that none of these meshes that the company had cited was implanted in a weight-bearing joint or intended to facilitate the regrowth of articular cartilage.

So the result was these plainly dissimilar devices counted as, quote, "same intended use." Of course the company downplayed the results from the randomized control trial. It said that the bench testing data, like whether or not you could pull the cartilage replacement apart or whether it could hold sutures well, should provide the primary basis even though it had already done a well-done randomized control trial that showed that the product had no public health benefit whatsoever. And it made a point before an advisory committee saying that the decision for the advisory committee should be based upon the function of this device as a surgical mesh and not the ultimate clinical outcome.

Let me tell you, as a doctor, this is really very painful even to think about. The clinical outcomes are the ones that matter to us, and when we hear Dr. Hamburg (sp), in particular, talking about putting the agency on a public health footing, this is what I think she must be talking about.

Subsequently, a number of irregularities in the advisory committee review of this product came to light. It turned out that ReGen was permitted early input into the questions posed to the advisory committee into who made the FDA presentation at the meeting, people who were not the original reviewers of the product. And even standing advisory committee members who were available to attend the meeting were replaced by clinicians thought more likely to favor the device. And all of the positive votes for this device came from the replacement advisory committee members.

So there really were very large irregularities here. The FDA is looking into this, and we hope that some of this will be explored further.

The third problem which might get you into 510(k), if not properly enforced, is different technological characteristics. The 1990 amendments to the Food, Drug and Cosmetic Act, provide for products with different technological characteristics to be predicates as long as no new issues of safety or effectiveness are raised. The problem is that this had led to predicates which are plainly different from the device up for approval, and thus products go through 510(k) when they should instead be going through PMA.

The example here is trans-cranial magnetic stimulation, or TMS, also a device intended to treat depression. The agency permitted TMS to be reviewed under 510(k) with electroshock therapy as the predicate device, even though electroshock is toxic, involves the administration of electrical currents to produce a generalized seizure. Whereas, TMS simply applies a magnetic field to a specific region of the brain. They did a randomized controlled trial. The results showed that the effectiveness of this product was statistically non-significant and clinically minor.

Now, I am not going to get into the details here, but this product was eventually approved through a process called the de novo process, which is not the subject of my testimony today, but suffice it to say, they couldn't have got to de novo had they not got to 510(k). And they could not have got to 510(k) without invoking the different technological characteristics provision. So one thing leads to another, and now we have this device that barely works that is on the market.

Let me conclude with two contextual matters, and then a final conclusion. The two contextual matters are that the matter of the least burdensome means of assuring effectiveness for devices that I believe Dr. Crosse referred to. This --

REP. PALLONE: Dr. Lurie, I just wanted the members to know we only have about three minutes left. I want to hear the rest of it, but just so you know, there's only three minutes left.

DR. LURIE: Well, I'll certainly finish well within that time


DR. LURIE: This give the industry recourse to challenge many requests that it regards as onerous. Indeed, ReGen invoked this very language when the FDA was considering the unfavorable findings of its randomized trial. So that's the first contextual issue.

The second is that, in general, the FDA is permitted scientific approaches that fall well short of the rigorous. And we've listed a number of things just in this, from the examples cited in this testimony, that are really unacceptable from a scientific point of view. Depending on the specific case, these lax scientific standards can be the result of any combination of the low standard for device approval, the inappropriate routing of devices through 510(k) instead of PMA, the least burdensome requirement, or simply the lack of rigor at the agency level.

Now each of the issues that have been identified in this testimony can be remedied by a combination of agency practice, regulation, and legislation. And to the former, even today under the existing authority, the agency can require greater scientific rigor, it can send more devices through the PMA, and it can tighten the same intended use requirements.

But legislation could also make a difference. It could address all three of the problems that I focused on today -- the lower approval standards for devices than for drugs, the permissive interpretation of same intended use, and the different technological characteristics loophole. We call on the Congress to pass exactly those three kinds of legislation. Thank you.

REP. PALLONE: Thank you, Dr. Lurie.

Now we, as I said, we have 28 votes, so it's at least an hour and 15 minutes, you know. Probably be back around 12:00, between 12:00 and 12:30. I think you all said you could stay beyond that, though. So we should be all right.

Without further ado, the subcommittee is in recess.


The subcommittee will reconvene. Let me apologize.

We really thought we would be done by 12:00 or 12:30 at the latest, and obviously that's not the case, so I really appreciate the fact that the three of you stayed. I know that Dr. Lurie said he actually had to leave at 12:30 anyway, but I appreciate the fact that you stayed here all this time.

The process -- basically each member is allowed to ask you questions for five minutes. And then, as I said, there may be written questions after, particularly since what happened today, there will probably be a lot of written questions. And then you should get those within 10 days or so.

So I'm going to start by recognizing myself for five minutes.

You know, what we're trying to do, obviously, is see if there is the need for legislation to correct the concerns that many of you have raised about the medical device approval process. And that's how you could be most helpful to us, if you have suggestions.

There is, of course, a bill that Mr. Dingell mentioned. Part of his -- well it's actually his and Bart Stupak and my bill, and others. But, you know, we separated out the food safety, but we still have the medical device and the drugs and the other provisions. But that, in my mind, is more oriented towards inspections, lack of inspection, lack of resources. I don't believe that it directly addresses whether we should change the procedure, in terms of, you know, of approval. I don't think it relates to that.

So that's what I kind of wanted to get answers from you on, and I guess my concern is that I don't think the issue is whether or not we should have a 510(k) process, although if any of you feel we shouldn't, you know, tell us. But I don't think the issue is that whether or not we should have it, but whether it is overly used and essentially abused, and whether or not this grandfathering, which was supposed to be essentially abolished, you know, should be abolished, and, you know, what, how long that should take or what the process should be to make sure that that's eliminated, if that's what you feel.

And I guess I'll start with Dr. Maisel, but I'll ask any of you the same question. It sounds to me like the 510(k) process is appropriate for a product that has the same effect as products that are currently safely and effectively on the market, almost like a generic, which maybe I shouldn't use, but I'll use it because I kind of understand that. But if a product has a new effect or is used in a new way, then it's important to go through the more rigorous pre- market approval process so that the patient can know that this new technology will actually work and work safely.

So I guess what I'm asking is, is my analysis of that correct? And if that's true, is the problem that, we know, we've essentially extended this 510(k) process beyond products that are currently safely and effectively on the market and products that are going to be very similar to those, and somehow we've gotten beyond that. And I'm just asking that very generally. And I'll start with Dr. Maisel.

DR. MAISEL: Well I think you have it essentially correct. I think Congress actually did a pretty great job in forming a device law that correlates the risk of the device and the risk to the patient with the degree of rigor in which a product is reviewed.

The problem with the 510(k), you do have it right. It needs in order to be substantially equivalent, it needs to have the same intended use and the same technological characteristics. And if the technological characteristics are different, then those changes can affect the safety and effectiveness.

What happens is that there's a lot of latitude that the FDA has in making those decisions. There's a lot of latitude in making a decision about whether a device has the same intended uses. We've heard this morning already. And there is no real good definition of what technological characteristics, what differences in technological characteristics should warrant a more thorough evaluation.

There's a lot of reliance on bench testing, on testing in the laboratory of these products. Which is fine, except that there is no great correlation in that that bench testing predicts clinical performance. And so there's this disconnect between the tests that are being done and how the product actually performs.

The other loophole that I think is a big loophole that we haven't really touched on is that companies can change their product and not file a 510(k) and not tell the FDA that they are marketing a different device. You do not have to file a 510(k) if a company changes a device and the company decides that there's no change in the safety and effectiveness of that device. Not the FDA. If the company decides that there is no change in safety and effectiveness, and it's the same intended use, then they don't even have to tell the FDA that they've modified their device.

And there's a great example of this. The Edwards ETlogix valve was on the market for two-and-a-half years. Many patients were implanted with it, and the FDA had no idea that it was even on the market. And finally they became aware it was on the market. They went to the company, and the company had followed FDA guidance that says, if you change your device and there is no change in the safety and effectiveness, you don't need to tell us about it.

I mean, that's a huge loophole that needs to be closed. And it's not that hard to close it. It requires legislation that says companies need to tell the FDA whenever they change a device and whenever they're marketing a modified 510(k), whether or not it affects safety and effectiveness.

REP. PALLONE: Now just, I'm going to ask the other two to respond too, although I know the time is almost up. But you've been waiting here for six hours, so I'm not going to worry about the time much. The -- (laughs) -- I'm sorry.

MS. : After all this, you take your time.

REP. PALLONE: (Laughs.) But you basically feel that we should have a 510(k) process. None of you -- well I'll ask the others -- but you're not advocating we should not have it, but that it is just over- utilized, it's much too subjective, there's a lot of loopholes.

DR. MAISEL: I think it's over-utilized. And it would have been interesting to ask Congress back in 1976 their vision of how, what percentage of products would have gone through the PMA process.


DR. MAISEL: I can't imagine that they imagined only 1 percent of the devices would go through the PMA process.

REP. PALLONE: All right, but now what about this grandfathering? I mean, I get so confused because it seems to me that you could have a device that was pre-'74, I guess, whenever we first passed the approval act. And that's grandfathered. Then you use the 510(k) to get approval for a device that's based on that grandfathered one. And then you can even use another device to grandfather, you know, to piggyback on the second one.

So we have, like, you know, generations -- you'll tell me if I'm wrong -- generations of devices that go back to this grandfather and never went through pre-market approval. I mean, how would you have us deal with that?

DR. MAISEL: I would have to say that I -- and I would be interested to hear what Dr. Crosse has to say because she spent a lot of time, obviously, looking at the 510(k) program -- I don't view that as a huge problem right now. I think the bigger problem is the FDA's assessment of the devices that are coming in front of them, and the rigor with which they evaluate those devices, that the level at which the bar is set for the evidence that the device is safe and effective.

I don't lose sleep over the grandfather issue.

REP. PALLONE: Okay. Well I'll let the other two answer, if you will. And then we'll go to Lois, and we'll see who else shows up.

Go ahead, either one of you.

Mr. Philips?

MR. PHILIPS: I think there should be a 510(k) process because, I'll tell you, I think that it has served consumers very well throughout the years.

And I think that if you look at the totality of old decisions, we're talking about over a quarter of a million devices that have been cleared through the 510(k) process since 1976. And I think, by and large, the devices that have become controversial are actually very few. So I think that there is overwhelming evidence that the program is actually a very valuable program.

Mr. Chairman, you asked a question about the grandfathering. And I appreciate Dr. Maisel's answer to that because I really don't think that it is a concern. All of those products that were grandfathered did go through an evaluation by experts, both on independent advisory committees -- and this is in my testimony -- I refer to 16 different expert advisory panels that reviewed all of these different types of devices.

And they went through all of the different generic types. They looked at available information that was in the public domain at that time, which was published peer-review literature. And they also factored in their own expertise. And they made the recommendations to the agency regarding what classifications those products should be placed in. And I think that that program, actually that process, had a tremendous amount of integrity.

As I said this morning, I think that part of the issues that we are all dealing with here, struggling with, is the fact that in 1976, Congress envisioned that all of these Class II products would be the subject of performance standards. And the agency was not successful at developing performance standards because the process was too resource-intensive. That was the agency's explanation then, and I can tell you it's the explanation today.

Congress did allow the agency to switch from performance standards to what's called special controls, which are very flexible means of trying to mitigate risks associated with devices. And it can include, actually, clinical testing. So when I made the recommendation this morning that serious consideration be given to developing special controls for all devices in Class III, what I was looking at was the situation that I think all of the panelists were dealing with, and that is these isolated incidents or clearances where there is criticism about not having proper clinical data, or having proper testing.

I think that there is a means under the existing statute to actually get all of those things in place for all of these problems, at least as an interim measure, before somebody thinks about opening the statute.

REP. PALLONE: Okay, thank you.

Dr. Crosse. And thank you for all you have done with the GAO report and all.

DR. CROSSE: Certainly. You know, we looked at this issue quite extensively, and I would have to agree that the 510(k) process in general seems to be working well and as intended. When we looked at the percentage of device applications -- not applications, I'm sorry -- under the 510(k) process device submissions that came in, you know, 86 percent of them were adjudged as having both the same intended use and the same technology, and only 14 percent as having a different technology that needed to be evaluated for whether it posed any risk to the safety of the device.

So the vast majority there are coming in as the same intended use and the same technological characteristics. I think the question is exactly what Dr. Maisel said. Is the evidence of that, that FDA is accepting, adequate?

Where we've had some problems in looking at FDA's reviews of devices, both under PMAs and under the 510(k)s, is the kind of information that FDA is accepting as sufficient to make their determinations. And that's really something that we're not qualified in any individual case to question, to say, no really, we have a different opinion about this technology.

So we're not coming out and pointing to specific devices, but I think overall you do have a question about whether or not there's a greater need for clinical data in some instances and whether FDA is accepting that small companies can't be accepted to have the same level of clinical information as a large company would be expected to produce, or that you can't have the same kind of studies being conducted and that this is enough, you know.

So that we have seen some evidence of that, but it's a small number of cases where we have seen that occurring. And so, you know, it's not a question of legislative authority. It's a question of the application of that in the scientific review.

REP. PALLONE: Okay. Thank you.

Our vice chair, the gentlewoman from California, Ms. Capps.

REP. CAPPS: Thank you. Excuse me. I'm going to try to avoid the questions that you've asked since it's just the two of us, to see how much we can cover quickly. Thank you very much on my behalf, as well, for your patience with today's proceedings.

I have two different topics to bring up. I'll address the first one to Mr. Philips, but I actually would love to get some comment from anyone who wants to on this topic, both of these topics.

One, the 510(k) process is only one component of the regulatory controls imposed on medical devices intended to ensure safety and efficacy. In fact, the U.S. model medical device regulations have been models for regulatory processes developed in some other countries as well.

Mr. Philips, can you describe, or does anyone want to describe other regulatory controls besides the 510(k) and their roles in protecting patients and health care professionals?

And let me just ask the question, the second one on this topic. I know there are concerns about these different elements of the approval and regulatory process. Does anyone want to comment on how congressional efforts to give the FDA more funding and resources could help this 510(k) and other processes as well, to improve and be more effective?

MR. PHILIPS: Yes, ma'am. If you look at the controls that are available to the agency to ensure safety and effectiveness, they actually have a wide variety of different controls. Pre-market notification is actually what's referred to as one of the general controls for medical devices. That's under the 1976 amendments.

Other general controls include provisions against adulteration and misbranding, there are labeling requirements, there is registration listing which basically identifies establishments so that they can do, the agency can do inspections. So G&P inspections would be part of the general controls. The same thing with some post-market surveillance activities. For example, records and reports like medical device reporting.

Those are referred to as the general controls and they apply to all medical devices, regardless of the class, because they apply to Class I, II, and III. It's interesting because pre-market notification is a general control that applies to all products, but under the FDA Modernization Act of 1997, most Class I devices were exempted from 510(k) review. In fact, the agency had the authority to reserve certain devices if they met what was called the reserved criteria, and there is probably 10 percent of the Class I medical devices that still come in under 510(k).

It's almost as if that action by Congress changed pre-market notification or 510(k) from more than just a general control but to a special control that would apply primarily to Class II medical devices.


MR. PHILIPS: I mean, in reality, that's what has really happened. It's also interesting because if you look at what the agency has under special controls, as tools that can assure safety and effectiveness, as I said in my morning testimony, they have a tremendous amount of controls that are available to them to apply to devices as they believe necessary, from not just pre-market notification, but, you know, patient registries in a post-market period.

There can be clinical data that's required. There could be specialized labeling. There can be agency guidelines that are put into place. So there's a wide variety of different tools that can be applied.

For the Class II devices, it's difficult to describe how well those controls can ensure safety and effectiveness because, by and large, Class II devices today are not subject to special controls. And that was sort of the problem that I pointed to this morning.

REP. CAPPS: Right.

MR. PHILIPS: Because I think that that would be one of the first things that I would think of, is that there could be more special controls, guidance documents, that looks at the risks that are associated with Class II devices, and figuring out what are the proper mitigation measures that can address those risks.

And again, I think that the agency has really a wide variety of things that are available to them should they elect to apply those for the regulation of devices.

As far as, you know, what efforts or funding could Congress ensure that the agency has, I'm not an advocate for just simply increasing FDA's budget by any specific amount or any specific percentage.

I've heard of people say, well the agency should have their budget doubled. I think that the agency should receive the funding that can allow them to take care of the priority issues that need to be taken care of. And clearly I think that the two that come to my mind is inspections, because clearly there is no question the agency has to have more of a presence in facilities, whether it's Class I, II, or III, than what they do today. That's one.

I think in the post-market area, I think, again, that's an area where there needs to be resources applied to the agency, not just necessarily in personnel, with the analysts that can look at MDR reports or adverse events that are coming into the agency, but also to improve the infrastructure that they have in order to be able to process the reports that come in.

I think, as Marcia Crosse indicated in her testimony, it is a tremendous amount of data that is coming into the agency, and I really don't think they are equipped to deal with that information as efficiently as what they really should. So I think that that is a big issue.

In the pre-market area, you know, we've already said that for the Class IIIs, the agency has already moved out to take the very first steps to ensure that they get the Class III devices, subject to pre- market approval. The steps that they have taken so far are the easy steps.

The more difficult steps are assuming that the PMA has come in for all of these different products. The agency is going to have to be able to process those applications, and they are not going to be able to process them at existing staffing levels. So with that, I'll close my answer.

REP. CAPPS: Okay. Mr. Chairman, do I have your permission to continue as though it was almost like a second round, or would you rather me stopping?


REP. CAPPS: -- I have another question.

REP. PALLONE: No, I think you continue, and then, Mr. Burgess is here, and we'll let him continue.


REP. PALLONE: Are you able to stay a few more minutes, Dr. Maisel?

DR. MAISEL: Yeah, I'm okay -- my flight.

REP. PALLONE: Okay. Go ahead.

REP. CAPPS: Thank you. Thank you very much. Since it's been this long, I feel like maybe we want to have a little more robust conversation than we might have otherwise. In other words, I'm interpreting what you're saying, and I want to see if anybody else wants to add to it.

The 510(k) model, while a good one, isn't offering -- there might be some others like inspection and post markets that, if there were more resources, could also add to the robustness of the regulations and the evaluation and achieving the goals.

MR. : Yes, ma'am.

REP. CAPPS: Would you like to comment?

DR. CROSSE: Well, yes, I would say, in fact, that the process requires the post-market steps, and, in fact, it's constructed to depend upon the post-market steps. And that's been where the greatest problems have been with FDA's resources and ability to attend to the kinds of adverse event reports that come in that let them know about problems that couldn't necessarily be uncovered --

REP. CAPPS: You'd never know until the post market --

DR. CROSSE: -- uncovered in advance until they are out and in widespread use --

REP. CAPPS: And you could make the correlation -- I mean, I'm not asking you to define it -- between the amount of resources that, since, if you're limited, you're going to put them into the 510(k), but if you had more you would put more, because inspections require more resources obviously.

DR. CROSSE: Well, it's that and it's structured under the user fees that there's funding for the pre-market steps.


DR. CROSSE: The user fees are paying for the pre-market steps --

REP. CAPPS: But not the post market.

DR. CROSSE: -- but had not been until very recently available to pay for some of these post market steps.

REP. CAPPS: I see.

DR. CROSSE: There is now additional funding for the inspections, and I would concur that that has been a great area of weakness and that they are now beginning to address. They are also beginning to address some of their IT infrastructure problems that have limited their ability to analyze some of the information that they have, even when they've received it. And so I think they they're beginning to take steps, but I see particular weaknesses on the post-market side.

REP. CAPPS: Okay. Any --

DR. MAISEL: May I respond to this, please?

REP. CAPPS: Yes, please.

DR. MAISEL: So I agree that certainly increased resources will undoubtedly help the FDA. I think it would be impossible to dispute that, and I agree that the post-market areas and areas like inspections will help. I think we'd be naive to think that throwing money at the issue is going to solve the problem.

REP. CAPPS: I agree.

DR. MAISEL: And I'm not saying you're implying that, but we could give the FDA unlimited resources. But if we don't change their approach to evaluating products, if we don't change the science-based evaluations, then we're still going to be faced with problems.

REP. CAPPS: I see. I'll turn to another topic then, with permission. You know, it's interesting. Usually when we think of FDA, we think of safety, but effectiveness is just -- we always say, safety and effectiveness. And today, we have focused primarily on safety, but whether a device works or not is, I would submit, equally important. I am sure you agree.

The history of the Food and Drug and Cosmetic Act includes many instances where Congress has had to tighten regulations because the products being marketed weren't living up to their goals, or were in fact ineffective. Despite this history, we hear from some that we need to keep the barriers low, even for potentially life-saving devices to enter the market.

To do otherwise, these critics argue, could stifle innovation and keep patients from treatments that may heal them.

But what concerns me is that if there is not enough study of the effectiveness of devices before they are marketed, patients and their doctors are forced to make decisions about whether or not to use a device that really may have never adequately been demonstrated to work.

Mr. Maisel, maybe I'll start with you this time. In this case, I'll just use an example because I was a co-author. I've been a school nurse, and so I know about external defibrillators. This panel has endorsed Ms. Sutton's bill, the Josh Miller -- and he was a student -- HEARTs Act in a bi-partisan fashion, because this bill would put life-saving devices in every school. It's a big step. Don't always think of schools as being a place where they are needed, but there is evidence that they have been.

I do agree with that policy, but I also am very concerned, particularly with not fully developed people, that these devices work. Dr. Maisel, can you tell us about that particular situation with your experience?

DR. MAISEL: Sure. I think you've picked out a very important medical device, external defibrillators, which have been proven in well-conducted clinical studies, to save lives.


DR. MAISEL: Sudden cardiac death claims about 330,000 lives each year in this country. It kills more people than AIDS, breast cancer combined. I mean it's a huge deal. And we are fortunate to have a good therapy.

Now, interestingly, the automatic external defibrillator is one of the Class III 510(k) devices mentioned in the GAO report. And if you doubt that there is an issue with the 510(k) program, this is the poster child for the problem. Because since 1996, there have been 52 recalls affecting automatic external defibrillators.


DR. MAISEL: There has been over 300,000 AEDs that have been recalled. One in five AEDs out in distribution in this country have been recalled.

REP. CAPPS: But yet they were put out.

DR. MAISEL: They were put out, and the challenge of -- I think it is unrealistic and impossible to think that every iteration of an external defibrillator is going to be clinically evaluated.

REP. CAPPS: Right.

DR. MAISEL: I don't think it should be, and I don't think it can be. But we need to figure out a better way to evaluate these devices --

REP. CAPPS: Do you have an idea?

DR. MAISEL: -- instead of just approving them each time, based on the fact that it's as good as the one that just came --

REP. CAPPS: Right.

DR. MAISEL: -- came down the line. I think another thing, another important point that you made was the safety and effectiveness point.

REP. CAPPS: Right.

DR. MAISEL: It is impossible to assess safety without knowing the effectiveness. If I told you a medical device kills 2 percent of the people who get it and ask you, is that safe or not, you can't answer the question. Compared to what?

You need to know, you know, maybe the disease is 100 percent fatal without the device and everyone lives who gets it, so 2 percent sounds great. Maybe no one dies without the device and 2 percent die with it, and then it's terrible. You need to know effectiveness if you are going to evaluate safety.

REP. CAPPS: I'll ask all three of you: Do you think we have adequate resources or methodology to do that?

Maybe that's too harsh a question. What should we be doing in this area that we're not doing now?

DR. CROSSE: I'm not certain that it's an issue of either resources or --

REP. CAPPS: Exactly.

DR. CROSSE: -- or methodology. I mean it seems to me it's an application of current existing approaches or an ability, perhaps in that particular instance, for the agency to say, you know, you can only have so many iterations before you have to provide some other sort of information, but that, which might be a different regulatory approach, it's not clear that there's evidence to establish that. It's not something we really directly looked at.

REP. CAPPS: There's not evidence to establish it or have we not asked those kind of questions?

DR. CROSSE: I think probably either.

REP. CAPPS: Is it an area that we should push?

DR. CROSSE: We haven't done anything that I would be able to give you any answer about how one might go about it, what would be necessary.

REP. CAPPS: Let me just focus on the recalls of the AED. Those came, I imagine, because some people had untoward effects. Or didn't work when they were trying --

DR. MAISEL: And so the FDA and our country has a medical device reporting system. And so adverse events that manufacturers become aware of that cause harm to patients are required to be reported through the FDA --

REP. CAPPS: Right.

DR. MAISEL: -- and companies become aware of these things. And so, since 1996, there have been approximately 370 deaths associated with failure of AEDs. And so, in response to device failures that get reported, companies become aware of them and recall their product because they have defects, whether they are related to the circuitry in the device battery function, these are complicated devices and things happen to them.

REP. CAPPS: Are they recalled at the insistence of FDA?

DR. MAISEL: Virtually every recall of most devices are, quote, "voluntary" recalls by the manufacturer, meaning that the manufacturer becomes aware of a problem and then chooses to issue a voluntary recall, sometimes with the coercion or urging by the FDA, and there are rare occasions where the FDA will issue a recall if the company doesn't. But most of them are voluntary and --

REP. CAPPS: Is there anything within the Food and Drug Administration that has jurisdiction in this area that, where if there is a recall, that there's an action that is taken by the FDA?

DR. CROSSE: Well, FDA has the authority both to order a recall --

REP. CAPPS: Right.

DR. CROSSE: -- or certainly to evaluate the information and urge the company, alert them to the problems that they are seeing and the adverse event data, if the company is not aware of it already. Usually the company --

REP. CAPPS: Right.

DR. CROSEE: -- becomes aware of something first, but, you know, one could argue, this is an example of the system working as it is designed, that when adverse events are identified, recalls occur.

I think the question then becomes, what does FDA do with that information if they see a pattern?

REP. CAPPS: Right.

DR. CROSSE: What then feeds back into their evaluations of subsequent devices when those applications come in? And I can't answer that question for AEDs.

DR. MAISEL: I would also say, if I were designing the FDA in a post-market surveillance system, I would want the FDA to be the one finding some of the problems. It's extremely rare that they are actually the ones that identify the post-market problem, despite the fact that they are asking for data.

Almost always it's the clinical community that comes up with the problem or the manufacturer gets reports and identifies it and reports it to the FDA. It's very rare that the FDA combs their database and their reports and comes up with an ah-hah moment where they have identified something.

REP. CAPPS: Well, Mr. Chairman, this is not a plan I want to belabor, but it seems to me a point that might interest a further discussion at another time. It appears to me that when something comes to light, when the public knows it, then, there, something happens. But I'm also mindful that you can't always count on that to happen necessarily. But I'll leave it at that, and thank you very much.

REP. PALLONE: Thank you. Thanks so much.

Mr. Burgess.

REP. MICHAEL C. BURGESS (R-TX): Thank you, Mr. Chairman. I thank the witnesses for bearing with us. I hope you were able to watch the drama on the television on the House floor all day. It was spellbinding. I'm sure you were on the edge of your seats through all of those reconsiderations.

Dr. Crosse, on the 510(k) process that we've been discussing. That's only one component of the regulatory controls imposed on medical devices intended to secure their safety and efficacy. What other controls are there, and what, if any, are the GAO's recommendations for the Food and Drug Administration to incorporate those, if they haven't already done so?

DR. CROSSE: Well, I think that the other key controls, from our point of view, are those post-market controls -- the ability of the agency to ask for further study, for additional data, for monitoring of the devices by the companies, and also the adverse event systems that FDA has.

We have not pointed to legislative remedies being needed in this area. The kinds of problems that we have seen are ones that FDA currently has authority, but in some instances not resources, to actually conduct, you know, the kinds of post-market oversight that's necessary. They have begun to take some good steps in that area.

They have a MedSun system that they have created where they have some additional surveillance, more active surveillance system ongoing. They haven't had the resources to be able to review all the reports that are coming in that are being generated by that system.

So that kind of control, we think, would be important for them to be able to exercise to have a better understanding. And, you know, as was just stated, to be able to identify some of the problems that may be cropping up more quickly to be able to take actions more readily and to ensure that they are on top of whether companies are following through on the commitments that they have requested at the time that something is cleared or approved for marketing.

REP. BURGESS: Dr. Maisel --

DR. CROSSE: So those kinds of controls.

REP. BURGESS: Does that fit, you know, with your description that you -- in a perfect world the FDA would be the one that finds problems and alerts the health care community to the problem. But the reporting system is such that, after just a few adverse events the FDA at least should develop some institutional curiosity as to investigating these.

DR. MAISEL: Right. I mean, I don't think the FDA should be the only one, and I think that Congress recognized that when they set up this system. We need people on the front lines reporting the adverse events and the device malfunctions. And, for the most part, manufacturers actually do a really great job of taking their product and the reports of malfunctions and figuring out what goes wrong, and fixing the devices and resubmitting 510(k) applications. That's what we want them to do.

But it would be nice for the FDA to be able to take the 200,000 device-adverse event reports that they get and be able to sort through those and find a pattern of malfunction or devices that are going wrong, with this large database they have. And there has been, you know, there will be investments in information technology, and they are moving in that direction.

REP. BURGESS: Well, I was just going to ask you, what is it that prevents that from happening today? Is it the IT architecture that's available?

DR. MAISEL: I think that's a major component. The other component is that the quality of the data they get is suspect. An adverse event report could say, patient had device implanted and died. And that could be the entire report.

So a lot of times they are spending time calling clinicians. They are trying to figure out what really happened. They might not even know the serial number of the device or the company that made the device. It's just very difficult for them to connect the dots, and it's going to require significant investment.

REP. BURGESS: Well now, you had a patient who had an implantable cardiac device and had an adverse event. Did you report that? How did you go about notifying the FDA that there was a problem? Or was that problem already recognized, and this was just one of many?

DR. MAISEL: It was both. I mean, the device had already been recalled. The patient had been informed that his device was recalled. We had had a discussion about the management options, and the lowest risk option for him was to leave the device in place, and unfortunately he had an adverse event.

I reported it to the FDA via the MedWatch system, but I'm an outlier of all the adverse event reports reported to the FDA. About over 95 percent come from manufacturers. It's very rare that health care providers report adverse events. There's little incentive for them to do it other than it's the right thing to do. And in the goodness of their heart, they don't get paid for it. It takes a considerable amount of time.

REP. BURGESS: Would a provider limit future liability that they might incur if they went through the adverse reporting system? Much like NASA has for the air traffic control system. There is a get-out- of-jail-free card if you report an adverse event in the nation's sky ways. Do we have such a thing for adverse events in the Food and Drug Administration?

DR. MAISEL: No, and I'm not really sure that that would have any impact on the reporting. I don't think physicians -- my sense is events aren't being reported because they are concerned about liability, they are just, they have like you a busy day, and there is 10 minutes of their day that they don't have to give away. They can go do something else and no one's going to come after them, and they don't have to do it, so -- . It's not required.

REP. BURGESS: Just one other observation on the AEDs because this has been important, and, yes, this committee has been involved, and I've been involved with my state legislators back home in Texas to get these devices at water parks, and high school football games, and what have you.

I'll never forget a town hall meeting I had in Southlake, Texas, one time, when a man went into v-tack, v-fib, sort of in the waiting area, and they fortunately had an AED, but it was locked up in the basement downstairs, so it really didn't do anyone any good. I can tell this story because the paramedics arrived quickly, and the AED, in fact, saved his life.

But after I got back up here to the Capitol, I began to look around, where are our AEDs? I was informed that we had appropriated money, and we had purchased the AEDs, and they were indeed locked up in a cabinet somewhere because we hadn't gotten permission from the architect of the Capitol to place the cabinets, and we hadn't agreed on the type of cabinetry that should be placed in these historic buildings around the Capitol.

So, you know, you can do all the right things and still be left with -- at some point the decision tree falls apart and you don't get the information or the device into the hands of the people who need it.

Dr. Maisel, based on your experience chairing the Food and Drug Administration's post-market heart device advisory panel, on the panel, how long does it take you to review a device when it comes to your attention, when there's a report made?

DR. MAISEL: The sponsor of the device and the FDA prepare a pretty remarkable panel pack that often runs into hundreds of pages that includes both the administrative record, a review of the bench testing and engineering, the clinical studies, and then we get it several weeks in advance, and it, you know, it takes hours, you know, probably 10 hours or more to review, and then we usually have an eight-hour meeting to discuss the results.

REP. BURGESS: So it is somewhat cumbersome and time consuming.

DR. MAISEL: I guess it depends on your perspective.

REP. BURGESS: Sure. Now, in April of this year, there were some Food and Drug Administration employees that sent a letter to the president saying that the device process was essentially broken. Now, is that a statement that you could find agreement with? Or do you think that's an over-reaction?

DR. MAISEL: I don't know that I want to comment on what these individuals said, because I don't know what their allegations are based on. I will say, I think we are here today because we all feel that there are things that can be done better. I can say, in working with literally hundreds of individuals at the FDA, I have yet to come across someone who I did not feel was trying to do the right thing for the American public.

It's not like there's people walking around at the agency who are trying to circumvent the rules. I think they are trying to do the best they can with the resources that they are given.

REP. BURGESS: So the motives are pure. But what about then the process itself? And what about the 510(k) process? And we've heard testimony that it may not even involve clinical testing in humans, that it may be just simply bench testing, or it may be testing in laboratory animals? Has -- ?

DR. MAISEL: Yeah, you know, I think Congress has done an amazing job of giving the FDA a road map, a recipe book of what they are supposed to do for certain types of devices. But there's leeway in that road map. There's judgment that the FDA needs to apply to a given device in a given situation.

And I think one of the problems is that judgment is applied inconsistently. And I think, for obvious reasons, we're focusing a lot on the 510(k), but I don't think we should completely ignore the PMA process. Yes, it represents only 1 percent of devices, but some of those individual devices go out to several million people. I mean there are millions, tens of millions of people who get PMA devices.

Four out of five PMA devices are approved via the PMA supplement pathway, not via the original PMA pathway. And the PMA supplement pathway -- 80 percent of the PMAs approved -- is a much, much lower bar. A lot of those PMA supplements are 180-day PMA supplements, which is a class that Congress set up. And that doesn't necessarily require clinical data.

The Sprint Fidelis lead that my patient had is a perfect example. That was approved via a PMA supplement, zero clinical data before this life-sustaining device goes into people.

REP. BURGESS: If we're given that, what -- and just speaking of the 510(k) world for a moment -- what changes to that process would you suggest? And are those changes within the purview of the FDA, or are they within the tools that they have right now, or is that going to require additional input from Congress?

DR. MAISEL: I do believe that the FDA has most of the tools that they need. Whether they will use them and be applied is a different story. And so that's sometimes where Congress can obviously help and direct them to apply.

I think that there needs to be better clarification of which type of 510(k) devices should have clinical data associated with them. I don't think it should be a case-by-case basis -- I'm a reviewer sitting at the FDA and I'm going to look at this device and make my best judgment.

There need to be standards. There need to be guidance, I think, from Congress, to the FDA about what you expect, what we expect to see for certain types of products. And it should be based on the risk of the product. And it should be based on the risk to patients.

I think you could weigh in the effectiveness as well, as we spoke about. I mean, for a product that is a life-sustaining product, that's a really important product, I'm willing to accept a different safety standard. I'm willing to have less data if it's a really important product. And for products that are a me-too product -- and we have other products that are just as helpful -- I think the standard is different.

But I think Congress can help by clarifying the standards for the FDA or, at the very least, FDA needs to be more transparent about how they are going to apply their standards.

REP. BURGESS: You may be over-estimating the ability of Congress, but --

DR. MAISEL: You can ask.

REP. BURGESS: -- I appreciate -- (laughter) -- the acknowledgment. Let me ask you a question that's really not fair, and it calls for rank speculation, and you may regret --

DR. MAISEL: I'm good at that, so --. (Laughter.)

REP. BURGESS: Yeah me too. You may regret that you've stayed here all day, but we're faced now -- of course, this is an important issue that we're dealing with, and we need to get it right. And the fact that we've been here all day focusing on it indicates that there is a problem that we need to get right.

Now, we're also in the process of looking at very complex biologic molecules, and I realize they're not devices -- these are medications. And the issue of follow-on biologics is coming up to our committee, and we are helping the FDA decide the best way to approach the assessment of a so-called follow-on product. And it seems to me there are so many similarities here.

I mean, although one's a device and one's a complex biologic molecule, we are talking about using a certification procedure that is somewhat abbreviated, or at least has the flexibility to be somewhat shortened from what the normal procedure would be in this case, in the biologics case, going through a new drug application, and, in the device case, going through the full PMA rather than a 510(k) process.

Is that an unfair analogy to draw between the issue of follow-on biologics and the issue that we're dealing here today with the 510(k) process?

DR. MAISEL: Well, I think you've described it well. I mean, they do have components of both drugs and devices. I think the lesson would be, we don't know a lot about them. There's a lot we still need to learn about biologics. And we need to have a total product life cycle. We can't just have a pre-market evaluation and put them on the market and start having patients get them and then forget about them.

At the same time, we don't want them to go into patients and just study them after they are into, you know, hundreds or thousands of patients. So I think whatever program is established needs to carefully balance the benefit to patients, or at least the potential benefit to patients so that we can get these important products out to them quickly, but at the same time study them, require post-market studies so that we can make sure that the products are doing what they are supposed to do and that patients are safe.

REP. BURGESS: And the concept of the life cycle is one that is really extremely important because many of these devices are implanted in someone whose forward life expectancy may be two, three, or four decades, and is the device capable of holding up in conditions inside the human body over that time, and particularly, the artificial joint replacements that we've seen. And even getting into dental procedures. There can be analogous situations there.

I really do appreciate you sharing that with us today. Mr. Chairman, I'm going to ask that since Dr. Lurie, I guess, had to leave, and I had a set of questions that I wanted to post to him, but can I do that in writing?

REP. PALLONE: Oh absolutely. And I said to the panel that since a lot of the members didn't come back, you should expect that you'll get some written questions. Usually we notify you within -- we ask the members to get them in within the next 10 days.

REP. BURGESS: You can have them before I leave.

REP. PALLONE: But we will, you know, open the record obviously for the written questions in light of -- well we always do anyway, but particularly today because of the long day -- (laughs) .

REP. BURGESS: Well let me just ask Mr. Philips one final question, as he has been so patient to sit here all day. Now we've heard testimony -- it seems like hours ago now -- that only 10 to 15 percent of 501(k) submissions contain any clinical data, and you have obviously had some experience working at the FDA. Do you think that within the 510(k) approval process that there should be some clinical data available or some clinical trials performed?

MR. PHILIPS: I think, without question, the answer is yes. Because what we've seen is clearly over time, evolution and technology, changes we've talked about, Dr. Lurie talked about, issues of intended use. And without question, when you start dealing with changes in intended use and changes in technology, invariably there's going to be situations where you are going to have to have human experience.

REP. BURGESS: And, so you really answered the second part of that question, that it should be human. It cannot be just bench testing or animal testing.

MR. PHILIPS: You know, it's interesting because I, you know, I'll tell you, I mean, you know, throughout my career I've hung out with a lot of engineers, and to a very large extent you find that you can get a lot of precise information regarding engineering analysis.

We talked about, for example, the breakage of a lead. There's a lot that you can do to characterize the strength and integrity of a lead. I think that, you know, for a pre-market evaluation, there has to be a balance that's struck.

And I think that we talk about the total product life cycle, and I think that from an FDA regulatory perspective they have to have the controls in place to provide adequate assurance, reasonable assurance of safety and effectiveness in the short term, but I think there needs to be post-market controls so that you can monitor, in a very vigilant way, performance, once products get to market.

I think that there are many situations where it's perfectly reasonable to allow a product to go to market based upon pre-clinical engineering analysis and data. But in order to do that, you have to have high confidence that you've got mechanisms in place that are going to be able to pick up problems once products are out and available in much larger population.

You know, clinical trials with a medical device is -- a large clinical trial is 2 (hundred) to 300 patients for a medical device. And clearly there's a limit as to how much you can even detect in a relatively small patient population. And to keep them on the duration of trials for a long trial is a two-year trial for a medical device. And many of these products if used as indicated are going to be placed into individuals for very lengthy periods of time, perhaps the rest of their life.

So I think that there has to be a focus on trying to figure out what the proper pre-market post-market balance is, so that we don't develop a system which really becomes a deterrent to industry, innovating and developing new technologies, but gives the American public the confidence that, once products are made available, that there's mechanisms in place to pick up any kind of events that represent, you know, something of significance that they need to know about or the clinicians need to know about.

REP. BURGESS: Well Dr. Lurie also referenced a compound that was used for articular surfaces, and the fact that this was a weight- bearing structure made a difference as well. So something like that, where there is a long length of time for intended use in someone's body, and there is a special situation that this is a, in a weight- bearing structure, it seems to me -- and obviously I'm not expert -- but it seems to me that this is one of those situations that would not lend itself to a facilitated or abbreviated process, but one where you would want to have the availability of all the data possible and then the longitudinal studies, since, again, we are talking about something that exists over -- is intended to be used -- over a long period of time, the longitudinal studies become very important as well.

Would you not agree with that?

MR. PHILIPS: Well, I would agree with that in kind, so -- but let me also disclose the example that Dr. Lurie was addressing in his remarks this morning -- I'm actually a consultant for that company, so I want to make sure that everybody is aware that there is that relationship.

But, you know, it's interesting because I think that you need to look at the body of evidence that was provided on that particular device, as well. It was a 510(k) clearance, but there was a tremendous amount of data. In fact, a lot more data in that submission than what is in the vast majority of 510(k) applications.

Now there can be a lot of discussion as to the quality of the data, what that data established, but I think for, you know, all practical purposes, the intended use of that device was well- corroborated with the data that was included in the submission. And I understand that Dr. Hamburg (sp) and Dr. Sharpstein (sp) are looking into that issue right now, and I would be interested to find out what their assessment is.

REP. BURGESS: Well, Mr. Chairman, I'll just come back to where I started this morning. It begs the question, where is the FDA? So I hope we will have a follow-up hearing at some point. And I know the calendar is condensed and compressed, and we are all pressed for time, but it's hard to have this type of hearing on this type of evaluation and evaluating rather the process that the FDA uses, without having the FDA here to weigh in on it.

And Dr. Maisel, let me just say too, I am so grateful you are here. And we've heard so much from the science board on the FDA that, yeah, we need to fund, they do need more money, but the procedures and the policies are things that need to be looked at, as well.

And then, of course, in the brave new world of the FDA regulating tobacco -- and I don't know how you ever decide that -- you can decide that it is effective, but I don't know how you ever decide that it's safe. And they've got a mission -- we've given them a mission -- that is virtually impossible for them to perform.

But I really appreciate all the witnesses being here today and staying with us so long. I'll yield back to the chairman.

REP. PALLONE: Thank you, Dr. Burgess. Again, thanks, you know, for your patience. But I'm glad that you came back and that we're able to ask the questions that we did ask today. We will have some more written questions, but thanks again. Have a good and safe trip home. And without further ado, the subcommittee hearing is adjourned.

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