FDA-commissioned report becomes vehicle for pharmaceutical companies' critics

A report commissioned by the US Food and Drug Administration has produced scathing criticism of the agency and the pharmaceutical industry, recommending 25 measures designed to improve consumer confidence. Many of the proposals are welcomed by industry observers, insofar as they aim to provide the FDA with the resources to perform its existing functions, as well as improve post-marketing approval oversight.

The Institute of Medicine was asked by the FDA to examine its effectiveness in the wake of the withdrawal by US drug major Merck & Co of its painkiller Vioxx (rofecoxib) (Marketletters passim). Sheila Burke, the reporting committee's chairperson, said: "we found an imbalance in the regulatory attention and resources available before and after approval." She added that "regulatory authority that is well-defined and robust before approval diminishes after a drug is introduced to the market."

Among the IOM recommendations are more funding for the FDA, increased powers for the agency to demand post-market authorization studies, clearer legal authority and enforcement tools, especially for the drug safety division. Drugmakers, in addition to the regulatory costs imposed by IOM proposals, would also face a ban on direct-to-consumer advertising for new drugs for two years, although the report's authors believe the FDA should be allowed to determine how long the ban would stay in force.