From the Washington Post:
The Food and Drug Administration said yesterday that it is making changes in the way it operates to prevent the kind of drug safety controversies that have dogged the agency in recent years.
Officials outlined plans to better monitor safety problems after drugs are approved and to make internal changes to increase the profile of agency scientists who raise red flags about drugs. The steps were announced in response to a report last year by the congressionally chartered Institute of Medicine (IOM) that called for an overhaul of the FDA’s culture and structure following safety controversies over drugs such as the painkiller Vioxx.
While the changes seem like a good start, the FDA still does not have the power to “impose fines and restrictions on companies that do not voluntarily follow the FDA’s directives,” and that is of some concern to consumer advocates. —MEGHANN MARCO
FDA Revamps Process for Safety of Drugs After Approval [Washington Post]