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Mr. HARKIN. Mr. President, after many months of bipartisan negotiation, I have high hopes that the Senate will vote very shortly to invoke cloture on the House message to accompany the Food and Drug Administration Safety and Innovation Act of 2012.
I am pleased to report it is the product of excellent bipartisan collaboration on the Health, Education, Labor, and Pensions Committee, which I chair, and productive conversations with our colleagues in the House. The House passed the FDA Safety and Innovation Act unanimously last week. Now it is our turn to do our part. The backbone of this legislation is the user fee agreement that FDA has negotiated with industry.
I might just add this bill passed this Chamber about 3 weeks ago on a vote of 96 to 1. So it has strong bipartisan support. A sizeable part of FDA's budget comes from user fees that industry agrees to pay to allow FDA to more quickly weekly review product applications. We need to authorize FDA to implement those agreements if we want to keep FDA running at full steam, which is critical to preserving jobs at both the agency and in the industry and to ensuring that FDA has the resources to get safe medical products to patients quickly.
I want to be clear. These agreements affect all of us by helping to maintain and create jobs in our home States. For example, in my State of Iowa, these agreements will support our burgeoning bioscience sector which saw employment grow by 4.5 percent between 2007 and 2008. The implementation of these agreements will continue to foster biomedical innovation and job growth in all of our States.
The bill before us reauthorizes the prescription drug user fee agreement and the medical device user fee agreement, both commonly known as PDUFA and MDUFA, which will continue and improve the agency's ability to speed market access to prescription drugs and medical devices while ensuring patient safety.
I just might add that, again, uppermost, foremost, first is patient safety. That does not mean we cannot do things in a better manner, get products more readily available, speed up the process if we have the personnel and the equipment to do so. That is why this bill is so important. It provides that type of support so we can hire more people to make sure we get these products to patients quickly, but to make sure they are safe.
The bill also authorizes a new generic drug user fee agreement which is expected to slash review time to one-third of current levels, from 30 months to 10 months, drastically improving the speed with which generic products are made available to patients. The new generic user fee agreement will generate significant savings for patients and our health care system. In the last decade alone, from 2001 to 2010, the use of generic drugs saved the U.S. health care system more than $931 billion. This agreement will ensure that we continue to see those savings and that patients have access to cheaper drugs when they need them.
This bill also authorizes a new biosimilars user fee agreement which will further spur innovation by the generic biologic industry. This chart shows again some of the savings we will get. The use of generic drugs has saved over $931 billion over the last decade, $158 billion just in 2010 alone. So we can see the better we are able to get generic drugs approved and in the pipeline--again, safely--the better off we are all going to be and more money that not only will we save as individuals but our entire health care system will save. That is almost $1 trillion over the last 10 years.
These agreements again, as I said, are vital to FDA's ability to do its job, vital to the stability of the medical products industry, and most importantly to the patients who are the primary beneficiaries of this longstanding and valuable collaboration between FDA and the industry.
After months of negotiation, FDA and the industry have crafted win-win agreements they stand behind. They are doing their job. Now it is time for us to do ours.
It is absolutely imperative that we authorize these user fee agreements before they expire. If we do not, FDA will lose 60 percent of its drug center budget and 20 percent of its device center budget. They will have to lay off nearly 2,000 employees. That is why it is so critical for us to do this at this time.
To be sure, the expiration does not happen until late this summer. But the FDA has told us if they do not get this reauthorization done, they will have to start sending out pink slips at the beginning of July. That is why it is so imperative for us to pass this legislation this week and send it to the President for his signature, so they will not have to go through that process of sending out pink slips.
But we can see how important this is. If this were to happen, it would have devastating consequences for patients whose health and lives depend on new medical treatments. We cannot let that happen. That is why for more than a year I worked closely with my colleague, the ranking member of the HELP Committee, Senator Enzi, and other members of the HELP Committee. Our aim has been to ensure that in addition to the user fee agreements, the other provisions in this legislation are also the product of consensus bipartisan policymaking.
We have used bipartisan working groups and an open, transparent process to ensure that we had input from our members and the stakeholder community at large throughout negotiations on the other titles of this bill. This is quite remarkable. We do not see much of it in this Congress these days. But we have had great cooperation from all members of our committee on both sides of the aisle.
This legislation has benefited greatly from all of the diverse input: from Senators, as I said, on both sides of the aisle, industry stakeholders, consumer groups, patient groups, and more recently from our colleagues in the House. The FDA Safety and Innovation Act is the result of concerted efforts to define our common interests, and these interests will directly benefit patients and the U.S. biomedical industry.
As you can see from this chart, the bill modernizes FDA's authority in several critical ways: It authorizes key user fee agreements to ensure timely approval of medical products. It streamlines the device approval process. It modernizes FDA's global drug supply chain authority, which is so important. It spurs innovation and incentivizes drug development for life-threatening conditions. It reauthorizes and improves incentives for pediatric trials. It helps prevent and mitigate drug shortages, and it increases FDA's accountability and transparency. So it addresses the broad array of critical issues that we face in today's global economy.
It is imperative that our regulatory system keep pace with and adapt to technological and scientific advances and that patient protection remains strong in this era of dynamic change. Keeping pace with the ever-changing biomedical landscape is precisely the aim of the FDA Safety and Innovation Act. This bill injects greater transparency into the device approval process. It bolsters FDA's ability to help U.S. manufacturers create innovative and safe devices, while also enhancing FDA's ability to determine how the devices perform in the real world and takes appropriate measures to protect patients.
The bill also reauthorizes and improves incentives for pediatric trials. It creates incentives for the development of new antibiotics and authorizes new drug and device provisions to help expedite the approval of important lifesaving drugs and devices without sacrificing safety.
In addition, the bill also helps address the national crisis prescription drug shortages. For the past several years, hospitals across the country and in my State of Iowa have experienced an increasing number of shortages of life-sustaining prescription drugs. These shortages directly threaten the public health by denying patients access to medications that are indispensable to their care. This bill requires all manufacturers of certain drugs to notify FDA if they expect a manufacturing disruption that could lead to a shortage because if FDA is aware of a potential shortage early, then the agency can work with manufacturers and providers to find other ways to get patients the drugs they need. This bill also addresses drug shortages by explicitly allowing FDA to expedite drug establishment inspections and application reviews when needed to help prevent or mitigate a shortage. It establishes an FDA drug shortage task force to develop a strategic plan to address drug shortages and to improve communication and outreach to stakeholders preparing for drug shortages.
Another significant advance in the bill is the much needed modernization of the FDA's authority to ensure the safety of drug products coming into the United States from abroad. This bill, No. 1, allows FDA to prioritize inspections of both domestic and foreign firms based on the risk they present to patient safety. It requires importers to demonstrate that certain high-risk drugs are safe and compliant before they can be imported into the United States. It requires manufacturer accountability and oversight of the quality and compliance of their drug producers and suppliers. It enhances penalties for adulterating and counterfeiting drugs. It allows FDA to detain noncompliant drugs in U.S. commerce to prevent them from reaching patients. It permits FDA to destroy certain illegal drugs at the border instead of releasing them back into commerce. It clarifies FDA's authority to address criminal conduct that occurs abroad and threatens the safety of U.S. consumers.
An important point to remember about the importance of these safety provisions is that weaknesses in our pharmaceutical supply chain not only affect the health of American patients, they also affect the health of American businesses. U.S. companies that source and manufacture drugs in this country should not be placed at a competitive disadvantage by foreign firms that operate with less oversight and sell substandard ingredients into this country at reduced prices. This bill will help ensure that businesses operate on a level playing field by holding foreign actors to the same high standards as those in the United States.
The last policy provision I will highlight is a mix of device and drug authorities that together can fairly be described as the most significant advance for patients of orphan and rare diseases since the Orphan Drug Act was passed nearly 30 years ago.
In addition to the significant resources that will be devoted to rare diseases under the prescription drug user fee agreement itself, this bill, No. 1, expands the accelerated approval pathway to therapies for rare and very rare diseases, and it instructs FDA to weigh the rarity of a disease as a factor in its approval process.
Next, it directs resources to promising therapies for unmet medical needs, which will receive the new ``breakthrough'' designation.
Next, it requires FDA to consult with outside experts on rare diseases.
Next, it focuses on pediatric rare diseases by requiring a strategic plan regarding pediatric rare diseases and creating a pilot program to incentivize new therapies for pediatric rare diseases.
Next, it helps make devices for rare diseases more available by modernizing provisions relating to custom devices and making it easier for companies to make profits on devices for rare disease.
Lastly, it reforms the conflict of interest rules for advisory committees to make it easier for the FDA to fill panels, which will have particular impact regarding rare diseases because those panels are sometimes very hard to fill.
I am very proud of the advances this legislation represents for patients with orphan and rare diseases.
Not only does the bill support the biomedical industry and help patients get the medical products they need, it also reduces the deficit. According to the nonpartisan Congressional Budget Office, this legislation will reduce the budget deficit by more than $311 million in the next decade. So what we have is not only good policy, but it is fiscally responsible by contributing to deficit reduction.
As I have said, well over a year of diligent, bipartisan work has gone into the legislation before us today. Neither Democrats nor Republicans got everything they wanted in this bill. We sought out consensus measures. Where we could not achieve consensus, we did not allow our differences to distract us from the critically important goal of producing a bill everyone could support. As a result, this is a true bipartisan bill, and it is broadly supported by the patient groups and industry. In fact, it has wide support from medical associations and also from consumer groups and manufacturers throughout the
entire country--a broad base of support. In fact, it is unique because it has the full support of manufacturers, the pharmaceutical industry, the device manufacturers, the FDA itself, and patients groups--people concerned about patient safety, cost, and availability of drugs and devices. So it has a broad base of support.
The FDA Safety and Innovation Act before us, which we will be voting on in a little while, authorizes the important FDA user fee agreements, and it modernizes our regulatory system to ensure safety and to foster innovation in the medical product industry. Our bipartisan work has produced an excellent bill. We cannot allow unrelated partisan disagreements or Presidential-election-year politics to interfere or keep us from completing our job.
I will say it again. We must pass this vital legislation now. It is critically important to the agency, to the industry and, most importantly, to patients that we get this done. Let's come together, Democrats and Republicans, to pass this legislation. Let's have a resounding vote on cloture. Hopefully we won't have to use the 30 hours and we can get to passage of the bill very rapidly so that we can get it down to the President for his signature.
With that, I yield the floor.
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