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Capitol Health Call
June 10, 2009

Enhancing FDA Inspections

JAMA. 2009;301(22):2318. doi:10.1001/jama.2009.782

Legislation introduced in the Senate on April 23 would give the US Food and Drug Administration (FDA) more resources to inspect domestic and foreign-made prescription drugs and devices.

Sen Chuck Grassley (R, Iowa) and Sen Ted Kennedy (D, Mass) introduced the Drug and Device Accountability Act of 2009 (S 882 [http://thomas.loc.gov]), which would expand the FDA's authority to inspect foreign manufacturers and importers, allow it to issue subpoenas, and give the agency the ability to detain a device or drug when its inspectors have reason to believe the product is adulterated or misbranded. The increased FDA workload would be funded by collecting inspection fees.

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