FDA - grab a broom, it's time to sweep the stables

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 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 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 that get published in medical journals, the report said. Studies that show positive results for a drug are more likely to be submitted to journals than negative ones.

The committee also took aim at FDA's 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.

"FDA's credibility is its most crucial asset, and recent concerns about the independence of advisory committee members ... have cast a shadow on the trustworthiness of the scientific advice received by the agency," the report said.

To reduce turnover and political interference, the institute said the FDA commissioner should be appointed to a fixed six-year term.

Other recommendations:

-- Put a symbol on the packages for new drugs to denote that their benefits and risks may not be fully understood. It would remain in place for two years.

-- Ban advertising directed at patients during that two-year period.

-- Review the risks and benefits of all new drugs after five years.

-- Bolster the Food and Drug Administration's safety staff and give it an integral role in drug approval.

-- Create an Internet registry to post results of clinical drug trials.

-- Adopt stronger policies to minimize conflicts of interest among outside advisers who serve on the panels that guide much of the FDA's work.

Source

Insider's view: Change and character starts at the top. That's certainly where the rot and smell in the FDA started, a while back!

It's an old but true saying that a fish rots from the head.

Not at "middle management levels" where there are thousands of decent hard working scientists struggling to keep the FDA on the right path.

People like the brave whistleblower Dr David Graham, for example.

Time to grab a broom and get sweeping.

From the top!