(09-23) 04:00 PDT Washington --
The federal system for approving and regulating drugs is in serious
disrepair, and dramatic changes are needed to fix the problem, a blue-ribbon
panel of government advisers concluded Friday 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 shared 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 FDA requested the drug safety review after the sudden withdrawal of
Vioxx in 2004 generated a firestorm of criticism over its drug safety program.
The widely used drug was pulled from the market by manufacturer Merck after a
company-sponsored study confirmed that patients taking Vioxx were more likely
to suffer heart attacks than those who did not.
The 15 experts drawn from academic and professional organizations were
unanimous in endorsing the recommendations, which called for several major
policy changes that have long been urged by drug safety advocates but have been
resisted by the industry, Congress and FDA itself. A number of them would
require congressional action.
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 re-evaluate safety and effectiveness data of such new drugs
within five years after initial approval, the panel added, and th