FDA advances Drug Watch safety initiative

A Web site could provide a window into the agency's decision-making process.

By Susan J. Landers, AMNews staff. June 13, 2005.

Washington -- An early warning system proposed by the Food and Drug Administration to alert physicians and patients to emerging risks posed by drugs already on the market is beginning to take shape, with draft recommendations published and an oversight board named.

The activities are part of the FDA's attempts to alleviate concerns raised about the agency's ability to ensure the safety of the nation's prescription drugs. The agency recently came under attack for what many charged were unnecessary delays in disclosing cardiovascular risks posed by COX-2 inhibitors and a heightened risk of suicide among adolescents who took selective serotonin reuptake inhibitors.

To prevent similar information delays in the future, the FDA intends to post to a new "Drug Watch" Web site data that suggest a drug poses a risk not seen during clinical trials.

"The purpose of the Drug Watch Web page is to provide a forum in which we can communicate emerging safety information to the public while we continue to evaluate that information," noted the FDA's draft guidance on the new system. The draft is available on the agency's Web site for comment until August 4.

The ultimate goal of the new initiative is to provide some "transparency" to agency decisions, said a spokeswoman. For example, one such web posting might read: "FDA is investigating postmarketing reports of renal failure in elderly patients treated with Drug A, but a causal relationship has not been established. We are continuing to analyze these reports to determine whether the occurrence of these adverse events affects the risk/benefit assessment of Drug A therapy."