M E M O R A N D U M
TO: Reporters and Editors
RE: GAO report on FDA post-market review
Senator Chuck Grassley, Ranking Member of the Committee on Finance, issued the comment below regarding a new report from the Government Accountability Office, “NEW DRUG APPROVAL FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints,” GAO-09-866, September 2009.
In March 2008, Grassley asked the GAO to provide an independent assessment of how the Food and Drug Administration follows up on the effects of medicines that it approves based on narrowly defined benefits called surrogate endpoints. The FDA can accelerate a drug's approval based on surrogate endpoints, and Grassley asked the GAO to assess how the FDA follows these approvals with required post-marketing studies for safety.
"Approvals based on surrogate endpoints can help to get new drugs and treatment possibilities on the market more quickly. Once those drugs are on the market, the FDA also needs to monitor the outcomes, and this GAO report indicates that the follow-up hasn't been happening as it needs to be. The report should serve as an impetus for the FDA to improve the post-market surveillance of these drugs, giving patients and their doctors' meaningful information and necessary safeguards."
Grassley has conducted extensive oversight of the FDA since 2004. His 2008 request of the GAO is posted at http://finance.senate.gov/press/Gpress/2008/prg030408a.pdf. The GAO report issued today is posted here.