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.
The bill also calls for an Institute of Medicine (IOM) study to examine the FDA's system for approving devices. Grassley, in a floor statement, said the IOM report was needed because of recent serious allegations raised by scientists within the FDA regarding . . . [Full Text of this Article]
