FDA - proposed changes fall short of what's needed

The FDA 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.

But!

A member of the IOM panel said the FDA had fallen short.

"In a number of cases, the FDA does not go as far as the IOM recommendations, but they are first steps and in the right direction," said R. Alta Charo, a professor of law and bioethics at the University of Wisconsin.

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