FDA Moves to Strengthen Postmarketing Rx Safety

Pharmacy Times, Volume 0, 0

Shaken by the discovery of serioussafety problems with Vioxx and a numberof antidepressant drugs approvedfor marketing in the United States, theFDA announced a series of new stepsdesigned to identify risks associatedwith prescription medicines currentlyon the nation's pharmacy shelves.

The measures include a new FDA-sponsoredstudy by the Institute ofMedicine to examine the effectivenessof the nation's new drug approval system,and a series of workshops andAdvisory Committee meetings that willexplore "emerging concerns" aboutmedications already on the market.

The FDA also plans to implement anew program for adjudicating differencesof professional opinion concerningpossible safety risks posed byapproved drugs. Because these scientific"disagreements can have a potentiallysignificant public health impact,"the new system will employ an independent"ad hoc panel" of experts toreview and resolve disputes, a representativefrom the agency said.