Congress Passes, President Signs, Powerful New Drug Bill Expanding FDA Powers - Drug Manufacturers Finally Lose on Capitol Hill

Mike Ferrara

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In a devasting blow to big drug companies, President Bush today signed into law a new drug safety bill. The bill was passed by the House and Senate, both controlled by Democrats, but it had bi-partisan support. The legislators were upset with the recent string of problems with bad drugs being approved by the FDA. The most recent fiasco was the world-wide withdrawal of the painkiller Vioxx, manufactured by Merck & Co., Inc. (NYSE: MRK). Merck lied to the FDA, lied to doctors, and lied to consumers about the safety of Vioxx. The new bill finally holds drug manufacturers responsible for their bad conduct. The FDA was granted additional oversight powers, including paying more attention to side effects of drugs already on the market.

It also gives the FDA the power both to require drug companies to do further study on the safety of medicines, if needed, and to mandate new label warnings when problems do appear. The FDA also gains the ability to fine companies to ensure compliance with those two new authorities. The legislation further requires companies to publicly release results of all clinical trials that show how well their approved drugs performed. Not yet approved drugs could be subject to the requirement later.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.