There's been a move afoot for some time to separate the FDA's drug-safety operations from the Center for Drug Evaluation and Research, which now oversees both drug approvals and safety. The thinking is that safety oversight should be independent, rather than cheek-by-jowl with the approvals process. That way, the people involved in approving a drug aren't the same people watching it for potential safety problems.
Well, that movement might have gained some traction. Bloomberg looked at FDA safety records and found that half of the 21 drugs withdrawn since 1995 were linked to cardiovascular problems. Presented with that data, Sen. Charles Grassley (R-Iowa) said it supports his efforts to create the new FDA drug-safety center. "The question is whether there are more drugs that should be on the list, and are not," Grassley tells the news service.
Grassley is working with Rep. Rosa DeLauro (D-CT) on a bill that would establish the new center, a separate Office of Surveillance and Epidemiology. Grassley's idea is that the center's staff would proactively study potential safety problems with drugs; he alleges that some red flags are now ignored.
It's true the FDA relies disproportionately on voluntary side-effects reports from doctors and patients. It is working on a computer network for post-market surveillance--the Sentinel Initiative--that would allow agency staff to sift insurance claims, electronic medical records and patient registries for potential safety problems. But that initiative is in the early stages.
- read the Bloomberg story