FDA to Expand Post-Approval Review of Drugs

Gardiner Harris of the New York Times reports today in an article entitled "FDA to Expand Scrutiny of Risks From Drugs After They're Approved for Sale" that the FDA has a new program called the "Sentinel Initiative" that will monitor how approved drugs affect consumer health.  They will use information from Medicare beneficiaries. 

Researchers praised the government initiative, but many said its fruits would take years to realize. And several said the Bush administration’s policy of delivering the Medicare drug benefit through myriad private plans made the effort that much more difficult.

“This is going to take a lot of work,” said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington.

Mr. Leavitt said “the power of this is in the capacity to take disparate databases and use it in a productive way.” Dr. Janet Woodcock, director of the F.D.A.’s drug center, agreed that much work remains to be done.

The article points out that this is better than what the FDA does now (the article explains that the FDA currently has "an unsystematic system in which doctors, patients and manufacturers report problems with drugs and medical devices when they deem them important.")   There are several problems with using Medicare data, including the fact that it is claims data not patient records and the fact that Medicare recipients use many more drugs than the general population, and are sicker than the general population. 

ADL