Food and Drug Administration Safety and Innovation Act

Floor Speech

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Mr. BLUMENTHAL. Mr. President, I am pleased and proud 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 is 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. This measure is revolutionary in many ways. It contains complex new provisions with bipartisan support. Truly, the bipartisanship in support of this bill makes it noteworthy as well.

I am pleased to say 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 now exist.

To provide more drug security, the supply chain needs greater safeguards. I have worked with Senators BURR, BENNET, HARKIN, GRASSLEY, and WHITEHOUSE on this measure. I am proud to say it is in here. The bill includes provisions on treatment and research on pediatric diseases and conditions that is the work of Senators REED, ALEXANDER, and MURRAY. I have been very proud to add to their efforts. Of course, it includes the work on medical device innovation and safety, which I have done with Senator Grassley and Senator Kohl.

This measure, in a way, epitomizes the approach we should take to FDA regulation, which is to enable devices to reach the market more quickly, to make sure they are safe but available more promptly, to guarantee surveillance and oversight after they reach the market, and reporting by industry so 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. 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.

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 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 and 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 they can care for patients who are literally dealing with life-and-death situations.

We are not talking about just 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 are talking about Mitomycin, about Doxil, about Cytaraline. In other areas of treatment we are talking about epinephrine, which is important for allergy treatment, zinc injections, which are necessary for nutrition deficiencies, Propoful, 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 are coping with pain, anxiety, sadness, grief, anger--and there are drugs available to them that would provide relief and remedies. Their docs cannot get them because they are in shortage.

We are talking about people of great courage and fortitude, such as Susan Block. She is just illustrative. I have her picture here. My office helped her to 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. 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.

She has allowed me, graciously, to share this photo with you today.

I am pleased we have been able to help constituents in Connecticut again and again to secure these medicines when they have been in shortage, working with manufacturers as well as hospitals in that effort. But it should not have happened at all.

Not everyone has been this lucky. Stephen Hine of Bethel wrote to my office after he lost his wife Ann. She died of terminal ovarian cancer. Ann was also on Doxil. While the drug was not going to save her life--these drugs do not always save lives--it could have prolonged her life expectancy. But she could not get Doxil in time and she lost her battle with cancer. Stephen, her husband, understood that the drug would not have cured her but it would have helped her live longer to spend more time with her family, her daughter, who was going to graduate that spring. 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 thank Senators KLOBUCHAR and CASEY particularly for championing this effort even before I arrived in the Senate and later, personally, the Chair of the Health, Education, Labor, and Pensions Committee and the Ranking Member, Senator HARKIN and Senator Enzi, for their support.

There are proven measures that will help solve these issues. 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 a 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 these drugs are in short supply was illustrated and documented by a GAO study. It showed that 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 generic. The market simply is not working for these drugs. The profit margins are not sufficient to sustain the supply. The market for these drugs is 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, perhaps with good intentions, but still not working effectively enough. 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. The markets are not working so there is now a gray market that involves markups of 200, 300, 500, 800 percent, 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. 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 am proposing as well an amendment that would require critical manufacturing reinvestment. I have 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. Over the long term, this kind of partnership will strengthen the markets and strengthen our capacity. It says 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 so far 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. I thank my colleagues on the Commerce Committee, Chairman Rockefeller, and also thank Senator Schumer for his leadership, because he has 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 and 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.

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