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Public Statements

Food and Drug Administration Reform Act of 2012

Floor Speech

Location: Washington, DC


Ms. KAPTUR. Mr. Speaker, I reluctantly rise today in support of H.R. 5651, the Food and Drug Administration Reform Act of 2012.

First, I would like to commend Chairman Upton and Ranking Member Waxman for putting together a bipartisan bill. Bipartisan bills are a rarity in this Congress and I hope we can use the goodwill gained in this bill to come together on additional measures, such as those that create jobs and promote economic growth.

While this bill has support from both sides of the aisle, from my perspective, it does not go far enough.

The Food and Drug Administration (FDA) is tasked with ensuring the safety of $2 trillion in products produced by industry. The FDA's approval of a company's products all but guarantees profits for that company.

Companies that benefit from the FDA's approval should significantly contribute to the FDA's budget to reduce the burden on taxpayers who are already paying for tax cuts for millionaires and billionaires and two unpaid wars. In FY 12, user fees comprised a mere 35 percent of the FDA's budget.

The FDA is facing many challenges. Approximately half of medical devices used in the United States come from abroad. Nearly 40 percent of the drugs Americans take are made overseas and about 80 percent of the active pharmaceutical ingredients are imported. Several years ago, contaminated heparin from China caused a number of deaths and illnesses in my Congressional District.

Additional resources are needed to properly investigate, inspect, and police foreign products like heparin to ensure American consumers are fully protected. Industry should be contributing more.

Despite my reservations, this bill is a step in the right direction. It reauthorizes user fees for prescription drug and medical devices at levels that should provide the FDA with sufficient resources to give patients access to therapies at the earliest possible time.

In addition, this legislation authorizes a new user fee for generic drug reviews. In the last decade, the use of generic drugs saved the U.S. health care system more than $931 billion. Consequently, I'm glad to see the underlying bill provides resources to improve review times to ensure safe generic drugs come into the market as quickly as possible.

Finally, the bill addresses some of my concerns regarding foreign products. I strongly support the provisions that require drug importers to register with the FDA, requiring sufficient information from importers to allow the FDA to implement a risk-based approach to import screening and barring the entry of imported drugs if deemed to have been delayed, limited or denied a full safety inspection.

I also strongly support the section of the bill that provides extraterritorial Federal jurisdiction to enable United States law enforcement to hold those accountable who violate our safety laws, such as those who are responsible for the heparin-related deaths in my Congressional District.


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