Harkin, Bennet Applaud Dingell Drug Safety Bill

House Companion to Bennet Bill will Improve Safety of Drugs for American Families

December 17, 2010

Washington, DC – Senate Health Education Labor and Pensions Committee Chairman Tom Harkin (D-IA) and Senator Michael Bennet (D-CO) today praised the introduction of U.S. Rep. John Dingell’s bill to protect consumers and American families by improving the safety and quality of pharmaceutical drugs.   

“Americans should be able to count on prescribed and over the counter medicines to improve their health, not make it worse,” said Chairman Harkin.  “We need to better protections against unsafe drugs and stronger oversight of the entire drug supply chain, and the bill introduced by Representative Dingell today goes a long way towards meeting those needs.  I am committed to working with him and Senator Bennet to address this in the new Congress.”

“Making sure pharmaceutical drugs are safe is important to me, not only as a U.S. Senator, but as the father of three little girls as well,” said Bennet, a member of the HELP committee.  “The FDA lacks the proper authority to adequately safeguard our drug supply and protect Colorado consumers.  Rep. Dingell’s bill takes steps to ensure the medicines Coloradans rely on are safe, and that those entrusted with the responsibility of developing these drugs are equipped to keep consumers out of harm’s way.  I look forward to working with him and Chairman Harkin to get a strong bill passed.”

Earlier this year, Bennet introduced the Drug Safety and Accountability Act of 2010, which would enhance the ability of the Food and Drug Administration (FDA) and the pharmaceutical industry to ensure U.S. drugs are both safe and effective regardless of where they are made.  The bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.  Bennet’s bill would provide the FDA with additional recall power, as well as other much-needed enforcement options, to respond appropriately to violations. It would provide better tools to investigate threats to drug quality and safety.  Additionally, it would provide new oversight of over-the-counter (OTC) drugs.  FDA has traditionally focused oversight on manufacturers of prescription drugs rather than manufacturers’ OTC products, which are taken by Americans every day. The bill would require FDA to establish accurate, interoperable information systems to track all plants making drugs and active ingredients for the U.S.

Bennet plans to introduce the bill again next year in the 112th Congress and will work to pass a bill that will ensure that American families can trust the drugs they take are safe and made with the highest standards and quality. 

In 2009, there were a record 1,742 drug recalls – a four-fold increase from the prior year, and the vast majority were related to manufacturing quality and testing.  Ensuring quality is made more difficult by the globalization of drug manufacturing. Up to 80 percent of the active ingredients in U.S. drugs are now made overseas, many in countries where regulatory oversight does not meet U.S. standards.

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