The Food and Drug Administration of the United States is now the patient on the examining table, with no shortage of attending doctors or nostrums. Months ago, the agency sought the advice of the National Academy of Sciences' Institute of Medicine on its drug safety system. The resulting report echoed previous suggestions that the agency should be given more money and power and proposed altering current industry approaches to drug development.1 2 3 4 The drug industry, already smarting from tightened FDA drug safety standards, went into defensive mode.

The Institute of Medicine report will certainly play a key part in an upcoming debate in Congress over renewal of legislation that empowers the FDA to collect fees for a portion of the cost of reviewing applications for drug approval. The current user fee legislation expires 30 September 2007 and must be reauthorised by then; this will provide a vehicle for new drug safety legislation if Congress decides it is necessary. With the recent US election results giving the Democratic Party control of both houses of Congress, it seems certain that the user fee extension law will include provisions to tighten drug safety law.

The current controversy is the latest in a series of drug …