FDA OUTLINES NEW DRUG PRODUCT SAFETY CAUTIONS

Pharmacy Times, Volume 0, 0

FDA officials have vowed to place a heavier emphasison prescription-drug safety. This move could lead tofewer product recalls in the future but also could resultin slower approvals of important new medicines.

The agency is already drawing criticism for a slowdownin the pace of approvals for new molecular entities—especially breakthrough drugs that could savetens of thousands of lives annually. At the same time,however, the agency is under pressure to avoid prematureapprovals of new drugs such as Vioxx (rofecoxib),which was withdrawn from the market after causing anumber of disturbing side effects.

FDA officials suggested that there would be more talkand less action in clearing new drugs. Key elements ofthe new approach will involve "improving communicationand information flow among all stakeholdersengaged in promoting the safe use of medical products,"and "the establishment of an advisory committeeto provide input to improve the agency's risk-communication...practices."