Is the FDA too conservative on safety?

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As the FDA continues to focus on improving and strengthening drug safety, it is seriously worried lest it become or seem to become too conservative, according to drugs director Steven Galson.

Addressing an update session at the Food and Drug Law Institute conference in Maryland this past April, Galson was asked to address whether FDA or its advisory committees are moving toward a more conservative safety posture, especially after Merck’s COX-2 painkiller Arcoxia was voted down the day before due to safety concerns, and keeping in mind that the product is currently approved in 64 other countries. Mexico was the first country to approve the drug in 2003.

“This is certainly an extraordinarily serious concern,” Galson said while noting that he had not been at the panel meeting where that occurred but did view a few reports of what transpired.

“The fact that the advisory committee so overwhelmingly acted on this,” he continued,

“I think underlines the issue that if you are concerned about the changes in conservatism related to safety, it is not just an FDA issue.

“We tried the best we could, as we always do, to have a very balanced committee, and if that very balanced committee saw this then it certainly raises the question about conservatism,” Galson said.

“One of the things I and senior managers in the center and at the agency are very concerned about is that we have to make sure that we are not going with the flow,” he said.

“That is, if the pendulum is swinging then we are not swinging with it, but we are trying to steer a steady course.”

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