Drug and Medical Device Manufacturers May Receive More Inspections from FDA

A bill introduced by Senators Chuck Grassley and Edward Kennedy would provide more funding for inspections of manufacturing plants that produce medical devices and pharmaceutical drugs. The proposal would give the FDA broad new powers in detaining questionable drugs or medical devices, allow the federal agency to issue subpoenas, and collect inspection fees from the company they are investigating.
The legislation comes in response to the contaminated Chines heparin as well as problems with manufacturing processes in medical device plants that make Stryker hip implants and Zimmer Durom Cup him implants.
While Congress has complained that the FDA has done a poor, ineffective job at regulating and inspecting medical devices and pharmaceutical drugs, the agency has argued that it is woefully understaffed and underfunded to complete the consumer safety tasks the federal government demands of the agency. This bill is widely seen as a corrective measure that would give the FDA the money and regulatory power to ensure better adherence to safety guidelines for both drugs and medical devices.