GAO Has Unkind Words For FDA

A GAO report had harsh and unsettling words to say about the FDA.

A year after announcing reforms, the FDA still doesn’t have a reliable system to keep track of developing problems, a federal report says.

The Government Accountability Office found that a new Drug Safety Oversight Board and other FDA initiatives were “unlikely to address all the gaps” in the agency’s system for monitoring the long-term safety of prescription drugs approved for market.

Although the board may help straighten out high-profile cases, the GAO said, day-to-day oversight of safety issues is still hampered by poor information, lack of legal authority to order drug company studies, and bickering between the powerful FDA bureau that reviews drugs for approval and a smaller safety office depicted in the report as a bureaucratic stepchild.

Do you think this could explain why it still takes so long for the FDA to notice that a prescription drug is killing and injuring patients?