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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

Location: Washington, DC


Ms. DeGETTE. Mr. Speaker, I'm delighted to support this bipartisan legislation which addresses critical problems affecting the safety of drugs and medical devices in this country. There are several highlights I'd like to talk about, like Dr. Gingrey's incentives for antibiotic development, or the supply chain legislation that Mr. Dingell has worked on tirelessly for years.

But there's one issue that I've been working on on a bipartisan basis throughout this Congress that I want to discuss briefly. Drug shortages have rattled our hospitals, our doctors, and our families. Figures recently released by the University of Utah show there were 56 more newly reported drug shortages in the U.S. last year than in 2010 when there were 211.

So, again, let me say 211 drugs in shortage. How can this be happening, and what can we do about it?

Representative Tom Rooney from Florida and I introduced the bipartisan Preserving Access to Life-Saving Medications Act, which eventually had 85 cosponsors. The bill creates an early warning system between the FDA, drug companies, and providers so a community can respond to a drug shortage quickly and efficiently. It won't solve the root problems of the drug shortage crisis, but it will help providers and doctors and hospitals identify those crises and help with the patient.

This February, for example, under a voluntary program, the FDA stepped in to allow for temporary emergency importation of the cancer drug, Doxil, which was in shortage. And at the same time, the FDA prioritized the review of a new manufacturer of the same drug when the cancer drug went into shortage.

So what our bill will do is make this program mandatory. What we think it will do is it will help patients across the spectrum get the drugs they need. It will help the hospitals and the providers identify potential shortages, and it will help the manufacturers better make sure that they get the drugs to the patients that need them.

I'm thrilled that this is contained, and I want to thank the chairman.


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