FDA wants full authority to control labeling for drugs

Mar 2 2005

Sandra L. Kweder, FDA's deputy director for new drugs, wants Congress to issue the FDA with the authority to control labeling for drugs to stop the prolonged disputes on this matter.

Even though the dangerous side effects of Vioxx were known, negotiations between the FDA and its manufacturer, Merck & Co., ( which took almost a year), over what a warning should say, delayed getting the information out to users about potential heart problems. Authority to dictate the labeling language along with the Bush administration's new policy on publicizing the full facts about drugs warnings, might have prevented the ensuing problems with the prescribing of the drug.

Merck withdrew Vioxx from the market Sept. 30 after heart problems were reported in some users; questions were then triggered about other so-called Cox-2 inhibitors - Bextra and Celebrex - prompting the FDA to elect an advisory panel to look into the matter.

The panel, on Feb. 18, decided that the arthritis drugs' benefits outweighed its risks of heart problems and strokes but that the products should carry strong warnings.

This week Massachusetts-based Mogen Idec Inc. and Elan Corp. announced they were withdrawing a drug to treat multiple sclerosis after it triggered a serious disease in two patients - killing one of them - when taken with other drugs.

Congress is considering legislation to tighten rules on how the government keeps track of the safety of drugs after the FDA approves them.

The Bush administration announced last month it will set up an independent Drug Safety Oversight Board to monitor FDA-approved medicines once they're on the market and update physicians and patients with emerging information on risks and benefits.