Looking Back at 2009 GAO Reports – Map to Future Changes at FDA?

J0443486I always think that one of the harbingers of future direction for the FDA is looking to see what the GAO has been saying about the agency.  I always say during speaking engagements that you can tell the new shape of a mountain volcano by the way the lava flows.  Well, our own little Hill spews lots of lava, and GAO reports are usually responding to some member (think hot air) for information.  

But seriously, the subject matter of many GAO reports seem to necessarily spur action on the part of the agency to remedy at least some of the issues noted in the reports.  That doesn't mean that all of these reports will result in FDA action, but one can discern some trends and thematically related reports that might result in further scrutiny – notably in post-marketing studies and commitments, for example.  The two under the device heading look for more stringent standards for approval and for tracking devices which is a safe bet for future action.  

Looking back at 2009, here are the GAO reports of note from a search done on FDA, divided by subject matter:

General:

  • FDA Needs to Establish Key Plans and Porcess for Guiding Systems Modernization Efforts – June 2, 2009
  • Considerations Regarding a Behind-the-Counter Drug Class
  • FDA Should Take Further Ations to Improve Oversight and Consumer Understanding (Dietary Supplements)

Drugs:

  • FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints – September 23, 2009
  • Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Process for Medical Product Investigators – September 25, 2009

Devices:

  • Shortcomings in FDA's Premarket Review, Postmarket Surveillance and Inspections of Device Manufacturing Establishments – June 18, 2009 
  • FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process – January 15, 2009

Food:

  • Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food – September 15, 2009
  • Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage and Transportation – July 24, 2009
  • FDA Safety and Consumer Protections Are Often Less Stringent Than Comparable EPA Protections for Tap Water – July 8, 2009
  • FDA Program Changes and Better Collaboration among Key Federal Agencies Could Improve Detection and Prevention – February 19, 2009

Drug Safety:

  • FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions are Needed – November 9, 2009
  • FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs – June 19, 2009
  • Food and Drug Administration Faces Challenges in Establishing Protections for Its Postmarket Risk Analysis System – June 1, 2009
  • Undercover Tests Show the Institutional Review Board System is Vulnerable to Unethical Manipulation – March 26, 2009


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