Pharmacy Times

FDA OUTLINES NEW DRUG PRODUCT SAFETY CAUTIONS


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

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however, the agency is under pressure to avoid premature approvals of new drugs such as Vioxx (rofecoxib), which was withdrawn from the market after causing a number of disturbing side effects.

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