Statement on Congressional Hearing Regarding FDA Drug Safety Reforms

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Washington, D.C. - Allan Coukell, director of the Pew Prescription Project, issued the following statement today, commenting on a hearing at the U.S. House Energy and Commerce Subcommittee on Health, where Food and Drug Administration (FDA) Principal Deputy Commissioner Joshua M. Sharfstein is expected to present testimony regarding the agency's ability to protect Americans from unsafe drugs made overseas:

"Two years after dozens of Americans lost their lives to contaminated heparin, we are still not able to protect U.S. consumers from many of the risks of pharmaceuticals manufactured in foreign factories. It is time for Congress to take action to better protect health. FDA must be given the tools it needs to protect our drug supply, which enters the home of nearly every American each day. Congress is right to focus on this important issue and today's drug safety hearing is a step in the right direction."

The FDA has received reports of 149 Americans who died after receiving heparin, all of whom suffered one or more symptoms associated with a known contaminant. The deaths occurred over a 17-month period in 2007 and 2008. Heparin, a blood thinner contaminated during manufacture in China, is an example of the movement of pharmaceutical manufacturing to the developing world and the increased risk that American consumers will be exposed to sub-standard and harmful drugs. A 2007 report by the U.S. Government Accountability Office estimated that 80 percent of the active ingredients in U.S. drugs are now made overseas, and that FDA has little ability to inspect foreign manufacturing sites. Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Margaret Hamburg have both said that the agency needs additional authority and resources to protect Americans.

The Pew Prescription Project is an initiative of The Pew Charitable Trusts to promote consumer safety through reforms in the approval, manufacture and marketing of prescription drugs. For more information, please visit www.prescriptionproject.org.