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Public Statements

Executive Session

Floor Speech

Location: Washington, DC


Mr. COONS. Mr. President, I rise today in strong support of the bipartisan legislation to which the Senate will move to reauthorize the Food and Drug Administration user fees and critical programs to ensure Americans have access to safe and effective medications.

Most of us do not think about the FDA on a regular basis. In fact, we rarely think about where our medicines come from, the scientists who invented them, the investments required to develop them, and the innovative, cutting-edge new treatments that are essential to keeping Americans healthy and safe or the regulators who make sure these pharmaceuticals, devices, and treatments work as they are supposed to. But when the moment comes that we face a health crisis and our doctors prescribe us essential medication, we want those pharmaceuticals available right away, and we want them to work as promised.

One example of the many constituents who have contacted me about PDUFA is Virginia from Newark, DE, who recently sent a letter to my office. She volunteers with the National Brain Tumor Society and is concerned that without reauthorization of this legislation, safe and effective brain tumor therapies will be slower to be developed and made available to patients who need them. She wrote:

It has been too long since any new therapies have become available for brain tumor patients that significantly extend survival. Anyone can be diagnosed with a brain tumor, and they are the second leading cause of cancer death in children under twenty.

I say to the Presiding Officer, I am sure, like me, in your office, as a Senator from Connecticut, you regularly are visited by folks from around the country or around your State who are deeply concerned about continuing medical progress, discovery and development of the lifesaving treatments Americans have developed over the last two decades. It is my hope that the Senate will continue to clear the way. That is why we need this legislation.

This reauthorization helps take care of innovation and safety so consumers and patients do not have to worry. It permanently authorizes programs that have helped make medicines safer for millions of children. It upgrades the FDA's tools to police the global supply chain and helps reduce the risk of drug shortages of the kind we saw recently, which Senator Klobuchar just spoke to earlier this afternoon, when supplies of critical cancer medications ran low.

This is a matter of great urgency. The current FDA authorization will expire in a few short months. If we allow that to happen, we put at risk patient access to new medications as well as America's ongoing global leadership in biomedical innovation.

Worst of all, failing to reauthorize would cost us thousands of jobs, and more pink slips is not what we need as our economic recovery gains strength. If new drug and medical device user fee agreements are not authorized before the current ones expire, the FDA must lay off nearly 2,000 employees. Because that does not happen overnight, layoff notices would start going out as early as July. The good news is we are moving forward with a timely reauthorization to save those jobs, save America's leading role in innovation, and ensure that the FDA continues to make progress.

This is an all-too-rare display of bipartisanship across both Chambers. This legislation was unanimously approved by the House committee and found strong bipartisan support in the HELP Committee here in the Senate, ably led by Chairman Harkin and Ranking Member Enzi.

There is a reason Members of the House and Senate of both parties are in such strong support of this reauthorization.

The American economy has always been driven by innovation, and some of our most extraordinary innovations have come in the biomedical sector. In the years ahead, it is my faith, my hope, that we will see more and more narrowly targeted drugs created specifically for certain kinds of patients or very specific diseases. In the lifecycle of innovation, this is different than the last few decades when blockbuster medications were used and then developed on a very wide scale across the country or world. But it is an equally impressive feat of innovation that lies in the years ahead, and one that is only possible because of amazing advances in technology, the mapping of the human genome, the disassociation across many labs and small startup businesses, of the machinery, the mechanics, and the capabilities to innovate in the discovery and development of pharmaceuticals.

We have to continue to support and encourage this kind of innovation in order to stay competitive in the global economy. At the moment, the FDA continues to keep pace with many of our global competitors in terms of their review time for new drug applications, but we are at real risk of falling behind.

One recent example to which I paid close attention, the blood-thinning drug Brilinta, was manufactured by a company--was developed and discovered by a company--in my home State of Delaware, AstraZeneca. It was finally approved by the FDA in July 2011. But prior to that approval, 33 other countries, including the EU and Canada, had already approved the drug months or years before. This delay in review and approval in some certain cases can be bad for patients who rely on these medications and bad for the competitiveness of the United States. So I am glad this reauthorization clears away some of the conflict in the underbrush and will reauthorize and strengthen and streamline the review timeline for new pharmaceuticals.

Not only will this provide the kind of predictability and certainty any business needs to succeed, but it helps make sure the FDA's essential regulatory process keeps pace with scientific innovation. In my home State of Delaware, there are more than 20,000 jobs that directly rely on biomedical research and innovation. But around the country there are more than 4 million indirectly and more than 675,000 jobs that directly benefit from this area.

Frankly, it is also one of our strongest export areas of growth for the long term. So we need this reauthorization now. In my view, moving forward with this legislation also means finding the fine balance between speed and safety, between getting treatments to patients without delay, and being certain these new drugs will be effective and safe.

In a recent editorial, the Washington Post noted:

This time around, the balance appears to be tilting slightly toward faster approval. That's good.

I agree. Safety is paramount, but with today's technology and the FDA's century of experience, I think we can move more quickly to put innovative treatments in the hands of patients who desperately need them. The Prescription Drug User Fee Act originally passed by Congress in 1992 and reauthorized every 5 years since is what allows the FDA to collect user fees from pharmaceutical manufacturers and provide a stable, consistent funding stream that has steadily decreased drug review times by nearly 60 percent since it was first enacted. It has provided access on a faster and more predictable timeframe to over 1,500 new medicines since it was first enacted and deserves to be reauthorized to help expedite approval for breakthrough medications to treat rare and widely experienced diseases.

In closing, the FDA is the oldest comprehensive consumer protection agency in the Federal Government. Its relevance has not decreased with age; in fact, quite the opposite. As our researchers and scientists have made major breakthroughs in care and technologies for treatment, the FDA has continued to serve as the conduit between innovators, physicians, and patients.

We face tremendous hurdles in treating devastating diseases of all kinds. In addition to ancient puzzles such as cancer that continue to allude us, there are new challenges cropping up every day. One example would be the need for new drugs to treat increasing cases of bacterial infections, greatly resistant to conventional antibiotics, so-called superbugs. That is why I have joined with the Presiding Officer and Senator Corker as a cosponsor of the GAIN Act, to spur development of these specific types of drugs. This is one of many examples of the kinds of innovations that will solve the medical mysteries of the 21st century, ease the suffering of millions of Americans, secure high-wage and high-skilled jobs in the biomedical research field, and ensure our competitiveness globally.

So let's continue working in the bipartisan spirit that has carried this reauthorization thus far and proceed to pass it without delay.

I yield the floor.


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