April 23, 2009

Legislation introduced to give FDA more power in dealing with foreign medical device and drug manufacturers

At a time when many Americans are frustrated and outraged over safety concerns regarding imported drugs and medical devices due to grossly inadequate FDA resources and the long-standing culture of wrongdoing and cover-up amongst FDA officials, bipartisan legislation was introduced today by Senators Charles Grassley (R-Iowa) and Edward Kennedy (D-Mass.), that would boost the FDA's power and augment resources in dealing with foreign drug and medical device manufacturers. Several highlights of the Drug and Device Accountability Act of 2009 bill include the following measures:

  • Augment FDA's resources to fund its increased activity through the collection of inspection fees (which may be passed on to U.S. companies who reply on such imports)
  • Allow the FDA to inspect foreign manufacturers and importers as frequently as every two years
  • Expand authority to provide subpoena powers to FDA
  • Allow the FDA to detain a drug or device when inspectors have reason to believe the product is adulterated or misbranded
  • Impose civil and criminal penalties for false or misleading application certifications regarding safety and efficacy data
  • Examine how the FDA deals with medical device review and approvals

"An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesn't know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year," Grassley said. "Our legislation is a practical solution to beefing up the FDA's inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency's work."

Click here to view the Government Accountability Office's report to Congress from January of 2009 about wide-spread FDA problems

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