OPINIONFDA's drug safety challenge: Making improvements without adverse eventsScrutiny of Food and Drug Administration procedures to ensure safety and efficacy should not impact the practice of medicine.Editorial. April 25, 2005. These are trying times for the Food and Drug Administration. It's long been considered the world's gold standard in ensuring the safety and efficacy of prescription drugs. But in recent months, the agency has suffered some black eyes. The first occurred when problems emerged regarding clinical trial data indicating that there could be an increased risk of suicidal behavior among children and teens who initiate therapy with antidepressant medicines. The result was significant soul-searching both within the FDA and beyond regarding how such data are collected. But this was only the beginning. Recently, when findings of cardiovascular risks linked to COX-2 inhibitors surfaced, FDA processes to ensure the safety of prescription drugs before and after they reach the marketplace once again were in the spotlight -- this time the focus of even more intense public and congressional scrutiny. The upshot now is a newfound level of oversight and activity. For instance, the FDA has made an effort to shore up its own systems. The agency announced Feb. 15 the creation of a new Drug Safety Oversight Board comprised of FDA members as well as medical experts from other Dept. of Health and Human Services' agencies and government divisions. Last month it also published guidance documents to help the pharmaceutical industry improve how it assesses and manages drug risk. Also in the works is a Drug Watch Web page, which will include the newest information for physicians and patients about safety risks for previously and newly approved drugs. [...]Full text of American Medical News content is available to AMA members and paid subscribers.
Copyright 2005 American Medical Association. All rights reserved.
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