(Washington, DC) – Today, Senator Richard Blumenthal (D-CT) spoke on floor of the Senate about the importance of addressing the drug shortage crisis in the FDA Safety and Innovation Act. Blumenthal highlighted stories he received from constituents affected by this crisis, and spoke in support of provisions he championed, including incentives to promote antibiotics development, promote safety and innovation of new medical device treatments, and provisions that expand the tools and authority of the FDA to strengthen requirements for advanced mandatory notification of disruptions in the production of lifesaving prescription drugs.
A full transcript of the floor speech is below:
I am pleased to follow Senator Harkin, one of the chief authors of the FDA bill, and to thank him and Senator Enzi for this truly bipartisan, monumental work on a measure that is essential to the future of the health of our nation as well as our economic security.
This bill is a big one. It's a big bill with complex provisions and an essential purpose: to safeguard the public, to protect patients and encourage innovation and invention, which are so important to treating and curing diseases in this country as well as other problems. And this measure is revolutionary in many ways. It contains complex, new provisions with bipartisan support, and truly the bipartisanship in support of this bill makes it noteworthy as well.
I'm pleased to say that it includes the GAIN act, which I helped to author and champion with my colleague, Senator Corker, and 15 other senators who have joined in this effort to incentivize the development of new antibiotics, to treat, stop, and conquer the superbugs, as they are known, germs that are resistant to antibiotics that exist now. To provide more drug security, the supply chain needs greater safeguards and I've worked with Senators Burr and Bennett, Harkin, Grassley, and Whitehouse on this measure. And I'm proud to say it's in the bill.
The treatment and research on pediatric diseases and conditions that is the work of Senators Reed and Alexander and Murray, and I've been very proud to add to their efforts. And, of course, the work on medical device innovation and safety, which I've done with Senator Grassley and Senator Kohl. This measure in a way epitomizes the approach that we should take to FDA regulation, which is to enable devices to reach the market more quickly, to make sure that they are safe but available more promptly and to guarantee surveillance and oversight after they reach the market, and reporting by industry so that we enlist industry as a partner and make the FDA an ally, not an adversary with industry in innovation and patient care.
Nowhere is this approach more necessary than in addressing the drug shortage problem in this country, and, it is a problem, it is a crisis, it is an outrage. The United States should be embarrassed and outraged that the greatest country in the history of the world, the strongest on the planet, having developed lifesaving medicines and devoted extraordinary research and development to make those medicines available to the people of this country, still has shortages, crisis shortages, in those very pharmaceutical drugs. And that crisis is inexcusable and unacceptable. The bill takes a step in the direction of addressing and solving this crisis. It is a first step. I leave no doubt as I stand here that I will continue to work on this problem to advocate other steps, some that I will suggest today and others that will be forthcoming in measures that I will propose later.
I first became aware of the drug shortage problem through contacts with people from Connecticut, patients who suffer as a result of these drug shortages, doctors who are hugely concerned about the choices they have to make and the dilemmas they face every day in their practices, and hospitals that engage in what they call triage, trying to find drugs to substitute for the ones that are in shortage so that they can care for patients who are literally dealing with life-and-death situations. We're talking not just about one or a couple of drugs -- methotrexate was recently the subject of a New York Times front-page article. It provides cancer treatment. But there are other cancer-treating drugs that are also in short supply, essential for both prolonging life and giving life to patients who otherwise would lose it more quickly. We're talking about Mitomycin, about Doxil, about Cytarabine and in other areas of treatment we're talking about Epinephrine, which is important for allergy treatment, zinc injections which are necessary for nutrition deficiencies, Propofol, a workhorse medicine commonly used in emergency rooms across the country when people arrive in need of anesthesia. For these drugs and hundreds of others, literally hundreds of others, to be in shortage is unacceptable and inexcusable.
What illustrates this problem perhaps most dramatically are the faces and voices of the people in Connecticut and in every state around the country who suffer because of these drug shortages. They are your neighbors, your friends, my colleagues' constituents. They're coping with pain, anxiety, sadness, grief, anger, and there are drugs available to them that would provide relief and remedy, and their docs can 't get them because they are in shortage. We're talking about people of great courage and fortitude like Susan Block, and she is just illustrative. I have her picture here. My office helped her get a drug called Doxil to treat her cancer because halfway through her chemotherapy treatments for ovarian cancer, she arrived at the hospital one day to learn from her doctor that Doxil would no longer be available. She called my office in a panic upon learning that information. Ovarian cancer causes more deaths than any other cancer of the female reproductive system, and Susan was unwilling to settle for half a treatment, and she was right and her doctor supported her, and my office supported her, in securing an emergency delivery of Doxil for Susan, allowing her to complete treatment. And she has allowed me graciously to share this photo with you today. I am pleased that we have been able to help constituents in Connecticut again and again to secure these medicines when they've been in shortage, working with manufacturers as well as hospitals in that effort.
But it shouldn't have happened at all. And not everyone has been this lucky. Steven Hine of Bethel wrote to my office, after he lost his wife Ann. She died of terminal ovarian cancer. Ann was also on Doxil. And while the drug wasn't going to save her life -- these drugs don't always save lives – it could have prolonged her life expectancy, but she couldn't get Doxil in time, and she lost her battle with cancer. Steven, her husband, understood that the drug wouldn't have cured her, but it would have helped her live longer and spend more time with her family, her daughter who was going to graduate that spring, and it would have meant so much for Ann to see her daughter graduate.
We have a right to ask, what kind of nation allows patients to go without these drugs and forces doctors to make decisions about who needs them the most? I want to thank Senators Klobuchar and Casey particularly for championing this effort, even before I arrived in the United States Senate, and later personally the Chair of the Health, Education, Labor and Pensions Committee and Ranking Member, Senator Harkin and Senator Enzi, for their support. There are proven measures that will help solve these issues, and more needs to be done, but the drug shortage provisions contained in the bill before this chamber, which provides for a requirement of notification in the event of discontinuance or interruption of the production of life-supporting, life-sustaining drugs or drugs intended for use in the prevention of a debilitating disease or condition or a sterile injectable or a drug used in an emergency are critical.
The reasons that these drugs are in short supply was illustrated and documented by a GAO study, and it showed drugs are in short supply – not just once, but they are chronically in short supply, some of them many times. It showed definitively that these drugs are old, sterile, often injectable, and generics. The markets simply are not working for these drugs. The profit margins are not sufficient to sustain the supply. The markets for these drugs are broken. If these drugs, to draw the analogy to a utility, were electricity, the lights would go out. We would not accept that situation. The lights are going out for patients in Connecticut and across the country because the markets are not working and the government, the FDA, is failing in its responsibilities, under great pressure, with perhaps good intention, but still not effectively working enough. And the president of the United States recognized it when he issued an executive order that required the FDA to use its current powers of notification more effectively and to refer price-gouging cases to the Department of Justice when there is evidence of them. And the markets are not working so that there is now a gray market that involves markups of 200%, 300%, 500%, 800%, sometimes even higher, in the prices of these drugs as they are resold in secondary markets.
Beyond this requirement of notification that is contained in the bill, there are other measures that are important or necessary so that we do more to address these problems. I have refiled my amendment from the HELP committee markup along with Senators Franken, Schumer, Cardin and Klobuchar to impose penalties, tough penalties, for manufacturers who fail to notify. Notification is fine, but it will be less effective if there are no penalties for failure to notify. And we may try to walk a balance between enforcement and incentives, but enforcement in this area is critical, and this measure imposing penalties for failure to notify is critical as well. The amendment is a fair one. It provides for penalties of up to $10,000 per day, up to $1.8 million per violation for failure to notify the FDA within a reasonable time frame of known discontinuance of a lifesaving drug.
I'm proposing as well an amendment that would require critical manufacturing reinvestment. I've worked with the manufacturing industry to create a public-private partnership to incentivize the development of additional manufacturing capacity. The root of the drug shortage problem is that these products are old and generic and difficult to make, so that we need more capacity, we need more plants making more of these drugs, and over the long term this kind of partnership will strengthen the markets and strengthen our capacity. It says that the Secretary of Health and Human Services has authority to implement an analysis of the root causes of the drug shortage and to proactively seek these kinds of partnerships with manufacturers to produce more of the drugs that may be in shortage right now, but to predict, to forecast, what will be in short supply in the future.
Market manipulation must be addressed more effectively. And I have proposed an amendment that will stop the gray market insofar as it is possible to do, to prohibit market manipulation of drugs that are in shortage, and prohibit the distribution of false information. It gives the FTC authority to assess penalties for these actions, and I thank my colleagues on the Commerce Committee, Chairman Rockefeller, and also thank Senator Schumer for his leadership because he’s shown a similar commitment to addressing these issues. Our doctors and our health care providers deserve some recourse from market manipulation. The gray market must be stopped and the FTC must immediately establish a reporting mechanism for price gougers and gray market profiteers.
These measures are a beginning. The notification provision now in the bill is a start. I thank, again, Chairman Harkin, Ranking Member Enzi for their leadership and the FDA for its cooperation. The work cannot stop with this bill. Drug shortages are unacceptable and inexcusable. And the people of America, if they are aware of it, will demand that we heighten the fight toward a Comprehensive solution.