Prometheus 6

Here's the report. You can read it online or order a printed copy or pdf.

The panel called for a moratorium on consumer advertising of newly approved classes of drugs until they have been on the market long enough for unrecognized side effects and risks to emerge. Packaging for new types of medications should also carry a special symbol, such as the black triangle required in Britain, to alert patients that the drug's safety profile would not be fully known until it had been more widely studied, the report said.

The FDA should reevaluate safety and effectiveness data of such new drugs within five years after initial approval, the panel added, and the agency needs new powers to impose fines and requirements on drugmakers. In addition, the report called for the agency to have authority to place a wider range of restrictions on drugs it deems risky. 

FDA Told U.S. Drug System Is Broken
Expert Panel Calls For Major Changes
By Shankar Vedantam
Washington Post Staff Writer
Saturday, September 23, 2006; A01

The federal system for approving and regulating drugs is in serious disrepair, and a host of dramatic changes are needed to fix the problem, a blue-ribbon panel of government advisers concluded yesterday in a long-awaited report.

The analysis by the Institute of Medicine shined an unsparing spotlight on the erosion of public confidence in the Food and Drug Administration, an agency that holds sway over a quarter of the U.S. economy. The report, requested by the FDA itself, found that Congress, agency officials and the pharmaceutical industry share responsibility for the problems -- and bear the burden for implementing solutions.

The report represents a watershed moment after two years of controversy over the safety of such widely used drugs as pain relievers and antidepressants. The Institute of Medicine is part of the National Academies, chartered by Congress to advise the government on scientific and health policy issues. Its recommendations traditionally carry great weight.

The 15 experts drawn from academic and professional organizations were unanimous in endorsing the recommendations, which called for several major policy changes. Several of these have long been urged by drug safety advocates but have been resisted by the industry, Congress and the FDA itself. A number of them would require congressional approval.

The panel called for a moratorium on consumer advertising of newly approved classes of drugs until they have been on the market long enough for unrecognized side effects and risks to emerge. Packaging for new types of medications should also carry a special symbol, such as the black triangle required in Britain, to alert patients that the drug's safety profile would not be fully known until it had been more widely studied, the report said.

The FDA should reevaluate safety and effectiveness data of such new drugs within five years after initial approval, the panel added, and the agency needs new powers to impose fines and requirements on drugmakers. In addition, the report called for the agency to have authority to place a wider range of restrictions on drugs it deems risky.

Manufacturers should also be required to register all clinical trials they sponsor in a government-run database to allow patients and physicians to see the outcome of all studies, not just those published in medical journals, the report said. Studies that show positive results for a drug are more likely to be published by journals than negative ones.

The committee also took aim at FDA management, citing a history of intra-agency squabbling and conflicts of interest on the expert advisory panels appointed by the agency to review the scientific data on proposed new drugs and devices. A substantial majority of advisory panel members should have no ties to industry, it said.