Vioxx's history and the need for better procedures and better testing.

After it was put on the market, Vioxx, a popular and widelyadvertised arthritis drug, was found to have cardiovascular risks. It took fourteen months of intense negotiation before a warning was added to the labeling, which cautioned about use by those with heart disease and the “unknown” significance of study findings. When a later study confirmed the risk, Merck, the drug maker, withdrew the drug voluntarily from the market. The finding of such a serious risk after the drug was on the market and the time it took for a warning to be given, led to a loss of public confidence in the agency and a debate about the regulatory system. At the agency’s request, the Institute of Medicine (IOM) of the National Academy of Sciences studied the agency’s regulatory system and issued a report (“IOM Report”) on the future of drug safety, recommending legislative and regulatory changes based on a “vision of a transformed drug safety system” that has “at its core a Lifecycle approach to drug risks and benefits.”