Monday, May 21, 2012
Floor Speech: Senator Coons urges colleagues to reauthorize FDA user fee programs
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 don't 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're supposed to. But when the moment comes we face a health crisis and our doctors prescribe us essential medications we want those pharmaceuticals available right away and we want them to work as promised.
One of the constituents who contacted me about PDUFA, Virginia fromNewark, Delaware recently sent a letter to my office. She volunteers with the National Brain Tumor Society and is concerned without reauthorization of this legislation, safe and effective brain tumor therapies will be slower to be developed and available to patients who need them. She wrote: “It's 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 20.”
Well Mr. President, I'm sure, like me, in your office as the Senator from Connecticut you are regularly visited by folks around the country or your state who are deeply concerned about continuing medical progress, discovery and development of the lifesaving treatments that Americans have developed over the last two decades and it's my hope that the Senate will continue to clear the way.
This is why we need this legislation. This reauthorization helps take care of innovation and safety so consumers and patients don't have to worry. It permanently authorizes programs that have helped make medicine safer for millions of children, it upgrades the FDA's tools to police the global supply chain and helps reduce the risk of drugs shortages of the kind that we’ve seen recently that Senator Klobuchar spoke of this afternoon when supplies of critical cancer medications run low.
This is a matter of great urgency. The current FDA authorization will expire in just a few short months and, if we allow that to happen, we put at risk patient access to new medications, as well as America's ongoing globalleadership in biomedical innovation. Worst of all, failing to reauthorize would cost us thousands of jobs and more pink slips are 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 doesn't happen overnight, layoff notices would start going out as early as July.
The good news is, we're moving forward with a timely reauthorization to save those jobs, save America’s leading role in innovation, and ensure the FDA continues to make progress. This is an all too rare a display, Mr. President, 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.
Mr. President, there's a reason members of the House and Senate of both parties are in such strong support of this reauthorization. The American economy's always been driven by innovation and some of our most extraordinary innovations have come in the biomedical sector.
In the years ahead, it's 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 life cycle of innovation, this is different than the last few decades when blockbuster medications were used and then developed 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's only possible because of amazing advances in technology, the mapping of the human genome and the disassociation across many labs and small start-up 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, Mr. President, in the global economy.
The FDA continues at the moment to keep pace with many of our global competitors in terms of their review time for new drug applications, but we are at realrisk of falling behind. One recent example that I paid close attention to, the blood thinning drug Brilinta was manufactured by a company, was developed and discovered by a company in my home state of Delaware, Astra Zeneca. It was finally approved by the FDA in July of 2011. But prior to that approval, 33 other countries, including the E.U. and Canada, had already approved the drug months or years before. This delay in 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'm glad that this reauthorization, Mr. President, clears away some of the conflict and 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, it's more than 4 million indirect and more than 675,000 jobs that directly benefit from this area. It's also, frankly, 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 in1992 and reauthorized every five 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% since it was first enacted. It's provided access on a faster and more predictable timeline 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.
Mr. President, 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 technology for treatment, the FDA has continued to serve as the conduit between innovators, physicians and patients.
We face, Mr. President, tremendous hurdles in treating devastating diseases of all kinds and 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 super bugs. That’s why I've joined with you and with 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, eases the suffering of millions of Americans, secures high-wage and high-skilled jobs in the biomedical research field and ensure our competitiveness globally. So, Mr. President, let's continue working in the bipartisan spirit that has carried this reauthorization thus far and proceed to pass it without delay.
Thank you, and I yield the floor.
###