FDA Cannot Meet Requirements for Inspections of Medical Device Manufacturing Facilities, GAO Report Finds
FDA cannot meet requirements for inspections of medical device manufacturing facilities in the U.S. and abroad, according to a Government Accountability Office report scheduled for release on Tuesday at a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 1/29).The report found that inspections of all medical device manufacturing facilities abroad would take FDA 27 years. FDA computer systems cannot determine the number of medical device manufacturing facilities abroad that export products to the U.S. or which facilities the agency has inspected, the report found (Harris, New York Times, 1/29). According to the report, FDA inspects U.S. facilities that manufacture the highest-risk medical devices once every three years and facilities that manufacture moderate-risk medical devices once every five years. "Both are supposed to be looked at every two years," the Journal reports.
The "GAO testimony on medical devices will be part of the hearing's broader effort to highlight an issue that has turned up in reports and critiques over the past few years: concerns the FDA's resources and technology aren't enough to meet its regulatory responsibilities to oversee drugs, food and other products," the Journal reports (Wall Street Journal 1/29).
The report also examined FDA oversight of imported foods and medications. Inspections of all food processing facilities abroad would take FDA 1,900 years, and inspections of all medication manufacturing facilities abroad would take the agency 13 years, the report found. The report attributed the problems with inspections of such facilities to inadequate FDA computer systems (New York Times, 1/29). House Energy and Commerce Committee Chair John Dingell (D-Mich.) has introduced legislation that seeks to improve FDA oversight of imported foods and medications through new industry fees (Wall Street Journal 1/29). This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
