Rep. Dingell Introduces Bill to Increase FDA Oversight of Drug Imports

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April 14, 2011

On April 12, 2011, Representative John D. Dingell (D-MI) introduced into the House of Representatives the Drug Safety Enhancement Act, a bill designed to increase the U.S. Food and Drug Administration’s (FDA) ability to regulate drugs manufactured outside of the United States. Representatives Frank Pallone (D-NJ), Henry Waxman (D-CA), and Diana DeGette (D-CO), co-sponsored the bill. Referencing a 2008 incident involving contaminated shipments of heparin from China, Dingell stated that the FDA needs greater authority to stop imports of unsafe pharmaceuticals from entering the United States.

 

The Drug Safety Enhancement Act would increase FDA authority over pharmaceuticals beyond the level established under the 2009 Food and Drug Globalization Act. It would require the creation of a registry of all foreign and domestic drug facilities serving U.S. consumers, foreign inspections similar to domestic inspections, and for manufacturers to identify and mitigate risk throughout their supply chain. Should a foreign facility refuse to allow FDA inspections, it would be barred from importing drugs into the United States. The bill also provides whistleblower protections for individuals who report safety violations.

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