Drug Safety

DRUG SAFETY -- (Senate - April 18, 2007)

Mr. GRASSLEY. Madam President, today I wanted to speak on an issue I speak on many times, drug safety. Today is a little different approach to it, though, because earlier today the Committee on Health, Education, Labor, and Pensions began marking up S. 1082, the Food and Drug Administration Revitalization Act. For the first time in almost a decade we have an opportunity to reform, to improve, and to reestablish the FDA as an institution committed to making patient safety as important as bringing new drugs to the market.

S. 1082 presents a framework for the future of drug and device safety. I am gratified by some of its current contents and I express some disappointment about others. That is the purpose of my speaking to my colleagues.

First, I am gratified the bill attempts to address some of the overarching issues plaguing the FDA that have been repeatedly revealed by the investigations I conducted of the FDA over the last 3 years. In particular, S. 1082 takes a number of steps to address the issue of transparency, the issue of accountability, and the issue of respect for the scientific process that has been lacking for some time at the FDA. S. 1082, for example, requires that within 30 days of approval, the action package for approval of a new drug must be posted on the FDA's Web site. This requirement, however, only applies to a drug with an active ingredient that has not been previously approved by the FDA. The action package would contain all documents generated by the FDA related to the review of a drug application, including a summary review of all conclusions and, among other things, any disagreements and how these disagreements were resolved.

If a supervisor disagreed with the review, then the supervisor's opposing review would be available to the public. And to address the many allegations that the Food and Drug Administration safety reviewers are sometimes coerced into changing their findings, I greatly welcome the provision that states a scientific review of an application is considered the work of the reviewer and must not be changed by FDA managers or the reviewer once that review is final.

The bill also takes steps to bring more resources to the FDA for drug safety, another matter I have been discussing for years. In addition, the bill requires the Food and Drug Administration's Drug Safety and Risk Management Advisory Committee to meet at least two times a year to address safety questions and to make recommendations regarding post-market studies.

I am also heartened to see that the bill incorporated several elements from the Dodd-Grassley bill entitled the Fair Access to Clinical Trials Act of 2007. S. 1082 ensures that the clinical trial registry includes trials of devices approved by the FDA. The bill requires a drug sponsor to certify at the time of the submission of a drug, biologics, or device application to the agency, that the sponsor has met all of the clinical trial registry requirements.

Last but not least, S. 1082 attempts to give the Food and Drug Administration some teeth by requiring specific civil penalties, monetary penalties for submission of false certification, and false or misleading clinical trial information.

These are, in my mind, some of the good things that are proposed in S. 1082. I wish to thank Chairman Kennedy and Ranking Member ENZI in this regard.

I hope additions such as these, which strengthen S. 1082, will make it through the HELP Committee's vote as the committee considers further changes. As I said earlier, I am both gratified and disappointed by the contents of S. 1082.

I turn now to some of what I consider to be lacking in the bill, that in my mind fails to address some of the issues that are critical to reestablishing the FDA's mission and putting John Q. Public and not PhRMA at the helm of the FDA.

I commend the HELP Committee's attempt to ensure that the office responsible for post-market drug safety is involved in, among other things, decisions made regarding labeling and post-market studies by making specific references to that office throughout S. 1082. However, the bill does not address the outstanding critical problem that the office responsible for post-market drug safety lacks the independence, lacks the authority to promptly identify serious health risks and take necessary steps that will protect the public.

As I think we all agree, the Federal Drug Administration is in desperate need of major overhaul. Over the past 3 years, my investigations have demonstrated that the depth and the breadth of the problems plaguing the FDA on both the drug and device side ought to stand out in everybody's mind as something Congress ought to be dealing with. Senator Dodd and I have written two bills that we believe will greatly enhance drug and device safety and improve transparency at the FDA and, most importantly, prevent another Vioxx debacle.

The Federal Drug Administration's Safety Act of 2007 and the Fair Access to Clinical Trials Act of 2007 are intended to address some of the problems plaguing the FDA at its very core. Those are the bills that are the Grassley-Dodd bill and the other is a Dodd-Grassley bill.

Let me be clear: Big PhRMA does not like these bills. FDA management does not like these bills. Lobbyists are spending hours upon hours lobbying against these bills. The Food and Drug Administration Revitalization Act does not embrace all the critical elements of the Dodd-Grassley and the Grassley-Dodd bill.

Let me ask each and every Member of the Senate the following: What is wrong with establishing a separate center within the FDA--not outside the FDA, within the FDA--with its only job being that of a watchdog for those drugs already in the market? What is wrong with supporting a group of committed FDA scientists who only watch for serious adverse effects that may pop up only occasionally, perhaps only 1 in 10,000 or 1 in 20,000? What is wrong with ensuring that all clinical trial results, regardless of their outcome, are available to the scientific community, health care practitioners, and the public? What is wrong with supporting a clinical trial registry and results database that also requires sponsors to reveal their negative trials? And what is wrong with giving the FDA strong enforcement tools to combat bad players?

I propose there is nothing wrong with any of these proposals, particularly the proposals that a new, separate, and independent center be created to address post-market surveillance, a proposal supported by Senator Dodd and me, not once but twice.

I have heard the naysayers and the naysayers' many bogus arguments about why a new post-market drug safety center will not work. The arguments range from the absurd to the ridiculous.

I will also address a few of those for you today. One argument is the creation of a separate center will slow down the drug approval process and delay much needed drugs from those who need them.

This argument is, in plain English, a nonstarter. Why? Because this new center will be devoted to keeping an eye on drugs once they are already on the market, postmarketing surveillance.

Another argument is that a new postmarket drug safety center will create an unmanageable bureaucracy at the FDA. That is a bogus argument. Why would taking an already existing office at the Food and Drug Administration, moving it on an organizational chart and providing it with new authority to watch for unknown and unexpected adverse events be bad? It does not make sense.

These arguments at first blush made an impression on Dr. Steven Nissen, chair of the Department of Cardiovascular Medicine at Cleveland Clinic and immediate past president of the American College of Cardiology, who was not an original supporter of establishing a separate center within the FDA to address postmarketing surveillance.

But, over time, his views have changed. Dr. Nissen probed more, evaluated the facts more, and as he talked more to on-the-ground FDA staff members, Dr. Nissen changed his mind and told the American public so.

Dr. Nissen recently sent me a letter stating that not only does he support the Fair Access to Clinical Trials Act but also the Food and Drug Administration Safety Act. In other words, Dr. Nissen said:

In particular, I support the creation of a new independent center within the FDA called the Center for Post-Market Evaluation and Research for drugs and biologics. Although I had previously expressed some concern about creating this center, I have become convinced that the separation of post-market surveillance from the Office of New Drugs represents the best opportunity to improve the performance of the FDA in handling drug safety issues.

I ask unanimous consent to have that letter printed in the Record.

There being no objection, the material was ordered to be printed in the RECORD, as follows:

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Mr. GRASSLEY. Coupled with Dr. Nissen's letter of support, I also received a letter from Dr. Curt Furberg, professor of public health science at Wake Forest University School of Medicine. Dr. Furberg is not only a professor of medicine, but he is also a member of the Food and Drug Administration Drug Safety and Risk Management Advisory Committee.

Dr. Furberg knows the FDA from the inside, and you might say he knows it inside-outside, in and out. In fact, even Dr. Furberg has written me to say he is supportive of creating a new center, and he is particularly supportive of creating a new enforcement tool to be used against bad players in the drug industry.

I also have that letter and would ask unanimous consent to have it printed in the Record as well.

There being no objection, the material was ordered to be printed in the RECORD, as follows:

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Mr. GRASSLEY. Madam President, if these two thoughtful leaders can come forward and support a new center that is devoted to watching drugs once they are on the market so that American consumers and their doctors know about a problem promptly, what is wrong with that? That is why I hope the HELP Committee will take a second look at the Dodd-Grassley bill. We have seen time and again that the FDA is not as good at this function as it should be. However, the reality is that the FDA needs to perform this function well because lives of American citizens and maybe around the world depend on it.

I wish to see a bill passed that prevents another Vioxx debacle. This Congress has an opportunity to make meaningful and positive changes. Let's not allow that opportunity to slip through our fingers.

MEDICARE

Madam President, I have another set of remarks that I wish to make dealing with the issue that we had before the Senate today, and that we had a cloture vote on, S. 3. Members on the other side of the aisle, including the assistant majority leader, said that Republicans do not want this debate. What are they talking about, do not want a debate about anything dealing with Medicare prescription drugs and all those sorts of things?

This body has debated the so-called prohibition on Government negotiation. The Senate had four votes on this issue. What is rather amusing to me about the statement that we do not want the debate is that they did not seem to want the debate when the Senate considered S. 1.

S. 1 was the Senate version of the Medicare drug law. That bill had a noninterference clause in it just like the current law does. It is that clause that the other side has distorted to come up with the absurd claim that no negotiations occur under the Medicare drug benefit. Not once, I repeat, not once during the entire time that S. 1 was on the Senate floor in the year 2003 did anyone on the other side of the aisle bring up this issue.

That is because this is not an issue of merit, it is simply one born out of political pandering. The assistant majority leader also talked about how Medicare should look like the VA because the VA seems to get lower prices.

The VA gets lower prices because the Government passed a law to guarantee itself an automatic discount that no one else can get. By law, that price is automatically 24 percent less than the average price paid by basically all non-Federal purchasers. That is not negotiation, that is a federally mandated price dictation, or you might call it a 24-percent discount, but it is federally mandated.

I agree that the logical question then is: Why not have Medicare get that price? Experts who testified at the Senate Finance Committee, even the VA itself at a 2001 hearing before the Committee on Veterans' Affairs gave us the answer: They said that giving the Medicare VA prices will increase prices for veterans. Now, why would anybody in this body want to increase prices for veterans?

Now I wish to turn to how the VA uses its own pharmacy benefit manager or PBM as we refer to them. The pharmacy benefit manager for the VA--the VA has one. In 1995, as part of an effort to better manage and monitor drug usage and purchasing and utilization oversight across the entire Veterans' Administration, the VA established its own benefit manager.

The VA did it because it wanted to have its pharmacy operation work similar to the private sector. They did it because, as stated in the VA news release, they wanted to maximize a developing business strategy in the private sector. That business strategy was getting lower prices on drugs in the private sector.

So here we have people holding out the VA as a model, which uses its own PBM to negotiate, and at the same time they are saying: Using PBMs in Medicare is wrong.

Remember, that process has brought 35-percent lower costs on the 25 most used drugs by seniors under the Medicare Program. I cannot help but see how that is a bit of irony when people say they want Medicare to negotiate like the VA negotiates.

Well, the VA negotiates through its PBM. So the funny thing is, the VA actually negotiates similar to Medicare drug plans. You heard that right, but let me state it again. The VA system for negotiating is just like the one already used by Medicare through prescription drug plans that seniors join.

If the VA's PBM looked at itself in the mirror, it would see a Medicare drug plan's PBM staring right back at it. There is another important difference between the VA and Medicare. The VA prescription drug benefit is just one part of the VA's health care delivery system. It is a very different system than Medicare.

The VA system requires veterans to use VA hospitals, to use VA physicians, to use the VA national formulary, to use their pharmacies, and to use their mail order pharmacy. Now, don't get me wrong. The VA has a good system that works for veterans. But what it comes down to is choice.

So I have a chart I want you to look at. Under the Medicare prescription drug benefit, beneficiaries have choices. They can choose the plan they want, a plan that covers all their medicines. They can choose the doctor and the hospital they want. They can go to their local pharmacy.

Even the VA recognizes this fact. On its own Web site in a ``frequently asked questions'' page, the VA does not recommend that veterans cancel or decline coverage in Medicare because a veteran may want to consider the flexibility afforded by enrolling in both the VA plan and the Medicare plan.

For example, veterans enrolled in both programs may obtain prescription drugs that are not on the VA formulary if prescribed by a non-VA physician and filled at a local pharmacy.

Making all Part D programs look like the VA and its formulary then will severely restrict access and will severely restrict choice to the 44 million Medicare beneficiaries. Now, the other side says: No. No. We are not going to limit access to drugs. Yes, as I pointed out this morning, every Democrat on the Finance Committee cast a vote against my amendment that would have prohibited the Secretary from creating a national preferred drug list.

I had thought, for all the talk about not allowing a Government formulary, the proponents of S. 3 would embrace a provision banning preferred drug lists. If they do not want to limit beneficiaries' access to drugs, my amendment should have been easy for them to support.

But by voting against my amendment, they were voting in favor of the Government setting a preferred drug list. Now, the preferred drug list might sound like a good thing, but in reality it is not. It is a Government-controlled list of drugs that you can or cannot have because the Government is not going to pay for what they say you cannot have.

The preferred drug list then operates similar to a formulary. In my opinion, if it walks like a duck, if it quacks like a duck, then it is a duck. But that is not what the courts have found. So what does that mean for Medicare beneficiaries? It means that even though S. 3 prohibits the Secretary from using a formulary, it does not prohibit the Secretary from using a preferred drug list. It is clear now then from all this analysis and their votes on this amendment that supporters of this Senate bill want the Government to set a preferred drug list. They want the Government to determine for what seniors can get coverage.

A number of States have implemented preferred drug lists. Michigan, for example, has a preferred drug list. Here is what the Kaiser Family Foundation found in a 2003 case study on that preferred drug list:

Fearing opposition from the pharmaceutical industry, the State sought virtually no input from providers, pharmacists, beneficiaries and manufacturers.

Continuing the quote:

Ultimately the department [meaning Michigan] made only a few changes to the list of drugs on the Michigan preferred drug list in response to beneficiaries and provider concerns.

Both the Illinois House and the Illinois Senate resolutions were introduced in 2002 to establish a committee to oversee that State's preferred drug list.

The resolution noted that the creation of Illinois' preferred drug list ``could lead to unintended consequences such as inferior health care, increased hospitalizations and emergency care, increased admissions into long-term care, and unnecessary patient suffering and potentially death.''

In a statement about this bill, S. 345, the assistant majority leader said that: The Medicare-administered plan envisioned under this bill would have a preferred drug list.

So this morning I talked about fitting all of the pieces of a legislative puzzle together.

Here are some of those pieces: The bill approved by the House allows price controls. The bill that was before the Senate does not prohibit the Secretary from dictating the drugs beneficiaries can get. We have Senator Durbin's statement about his own bill and how he envisioned a preferred drug list.

So despite claims by those on the other side of the aisle, this bill is not harmless to senior citizens. If this Trojan horse attack succeeds in a Government takeover of the drug benefit, here is what seniors can look forward to: They can look forward to fewer choices. They can look forward to fewer opportunities to choose a plan that best meets their needs--the needs of 44 million senior citizens in America.

If the Senate bill were to pass, seniors will get only the drugs some Government bureaucrat determines they can have. All other Americans will see the prices of their prescription drugs going up. That is not me saying it. Professor Scott Morton of Yale University testified before the Senate Finance Committee to that mathematical fact, that if you have 44 million senior citizens, and you have the Government dictating the price, when you deal with that number of people, the price is going to go up for everybody. If that is what the other side calls harmless, I shudder to think what their definition of ``harmful'' might be.

We should have and did stop this bill in its tracks. Voting no was a vote against Government-controlled drug lists, Government setting prices, and Government restrictions on seniors' access to drugs. That was the right thing to do today, and I am glad the vote came out the way it did. I hope it stays that way because if it ain't broke, don't fix it.

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