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Waxman, Dingell, Pallone & Stupak Open Discussion on Potentially Historic Changes in Drug Safety Laws

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Today Rep. John D. Dingell, Chairman Emeritus of the Energy and Commerce Committee, Rep. Henry A. Waxman, Chairman of the Energy and Commerce Committee, Rep. Frank Pallone, Chairman of the Subcommittee on Health, and Rep. Bart Stupak, Chairman of the Subcommittee on Oversight and Investigations, released a discussion draft of legislation to equip the Food and Drug Administration (FDA) with the authorities and funding it needs to regulate what is now a global marketplace for drugs. The discussion draft released today builds on H.R. 759, the Food and Drug Globalization Act, which was introduced by Dingell, Pallone and Stupak last year, and reflects the reasoned priorities and recommendations of the Food and Drug Administration (FDA).

The discussion draft requires parity between foreign and domestic drug facility inspections, increases the number of pre-approval drug inspections, prohibits the entry of drugs into the United States lacking documentation of safety, requires manufacturers to ensure the safety of their supply chain, and grants FDA authority to mandate recalls of unsafe drugs.

"We've learned more than a few troubling truths on the safety of some prescription medications and we've learned it the hard way -- with tragedies," Congressman Dingell said. "Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this, the only question now is how. We must ensure the Food and Drug Administration is adequately equipped to carry out the important mission of protecting American consumers. The authorities included in this discussion draft will make substantial progress in addressing those concerns and ensuring that FDA and the regulated industry are doing all they can to ensure the drugs we take are safe and effective."

"We cannot forget the lessons of the 2008 heparin contamination incident," said Rep. Waxman. "That catastrophe showed us that we are susceptible to new threats as a result of our increasingly globalized drug supply. We need to ensure that FDA has modern authorities and enforcement tools to help protect us from these threats. This draft legislation will provide the tools and resources the agency needs to do just that. I look forward to working with FDA and all stakeholders to move this legislation forward as soon as possible."

"The byproduct of Internet communications and a rapidly-evolving international marketplace is an increase in the purchase of medications from foreign sources," said Pallone. "One of the downsides is quality control and one of the dangers is the threat to the health and safety of consumers. We need to find the best ways to vest the FDA with the ability and the authority to ensure the safety of medications consumed by Americans."

"With more and more of the U.S. drug supply being manufactured overseas, it is vital that we equip the FDA with the authority and the resources it needs to ensure that imported drugs are safe for American consumption," said Stupak. "The need for increased regulation was clearly demonstrated in 2008 with the tainted drug heparin, which killed 80 people. We cannot continue to allow foreign manufacturers to produce drugs for the American people without granting the FDA strong regulation authority and enforcement tools over these entities. It is critical that we implement the proactive measures included in this legislation that would protect American consumers and dramatically improve the safety of foreign-produced drugs."

The Chairmen will be working with Members of the Committee and stakeholders to refine the legislative draft.

The portions of H.R. 759 concerning food safety were the basis of a separate bill, H.R. 2749, the "Food Safety Enhancement Act," which passed the House by a 283-142 vote last summer.


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