Healthy Skepticism Library item: 13030

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Publication type: news

Congress Questions Surrogate Endpoints as FDA Pushes Them
FDA Week 2008 Mar 7
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1747130&contentType=sentryarticle&channelID=33

Full text:

Congress’ investigative arm will probe the use of surrogate endpoints for drug approvals at a time when the FDA is spearheading their development to bring drugs more quickly to the market. The Government Accountability Office is investigating the matter at the request of Sen. Charles Grassley (R-IA).

FDA allows drug companies to get drugs approved based on how they affect biomarkers, such as lowering cholesterol levels, that are surrogates for clinical outcomes, such as reducing the risk of strokes and heart attacks. When companies use surrogates, they are supposed to continue testing products once on the market to ensure that the surrogates accurately predicted how well and safely the drugs work.

Grassley primarily is worried about FDA’s ability to get companies to finish such post-market studies. But some say the GAO study could also fuel a more general attack on the use of surrogate endpoints.

The GAO investigation will include reviewing the number of drugs that have been approved based on surrogate endpoints, the surrogate endpoints that FDA uses to approve drugs, and for each of these drugs identified, the date each was approved and whether companies finished post-market trials.

In recent years FDA has encouraged the development of surrogate endpoints.

Many of the Critical Path Initiative goals that FDA released two years ago involved developing and verifying surrogate endpoints and biomarkers. But FDA is cash-strapped and the Critical Path Initiative was barely funded so the agency got Congress to create a nonprofit foundation, called the Reagan-Udall Foundation, to take it up. The foundation is partially funded by the drug industry, which has made it controversial among some consumer groups and Rep. Rosa DeLauro (D-CT), chair of the appropriations subcommittee responsible for FDA’s budget.

The same law that created Reagan-Udall reauthorized drug user fee law. FDA negotiated the goals of the user fee program with industry before handing it over to Congress to reference in statute. The goals include letting FDA spend user fees on writing guidelines for biomarkers and trial designs that use surrogate endpoints.

The Pharmaceutical Research and Manufacturers of America issued a release defending FDA’s reliance on surrogate endpoints for approvals.

“Drug approval decisions based on surrogate endpoints approved by the Food and Drug Administration (FDA) often allow patients to access life-saving and life-enhancing remedies more quickly,” the release states.