Report cries foul over FDA's fussing and feuding

Take the Pill,
originally uploaded by messyatwork.

Experts at the Institute of Medicine in Washington, who advise the government on health, released a report (available for purchase here) that looked at problems at the U.S. Federal Drug Administration following the withdrawal of the painkiller Vioxx in 2004. The FDA partially sponsored the report. It emphasized the lack of post-approval oversight and the need for labeling and advertising restrictions on newly approved drugs.

“More drugs are being approved faster with less time to intensively investigate pre-marketing safety data,” the report said (CBC).

The report also criticized the FDA for being plagued with poor management and persistent internal squabbling.

“While we have done a lot of work over the past two years to improve the drug safety enterprise at FDA, we recognize more remains to be done,” said FDA spokeswoman Susan Bro (CBC).

The report’s recommendations include:

• Boost the budget of the FDA.
• Approve drugs for five-year periods so that the FDA can thoroughly review post-approval safety questions.
• Add a symbol, such as a black triangle, on new drug labels to warn consumers and doctors of the uncertainty surrounding their safety compared with older drugs.
• Ban advertisements of drugs during their first two years on the market.
• Authorize the FDA to issue fines, injunctions and withdrawals when drug makers fail to complete required safety studies.
• Lengthen the term of the FDA commissioner to six years instead of an open-ended assignment.
• Ensure at least 60% of members of FDA advisory panels are free of “significant financial involvement” with companies that may be affected by the decisions.

The need for further oversight and post-approval reviews was disputed by the pharma industry.

“Drugs are approved as safe and effective by FDA under the conditions that are prescribed on the label. The label can highlight that there are issues with the drugs, with respect to how they are used. I don’t think it’s fair to characterize all new drugs as requiring heightened regulatory uncertainty,” said Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America (New York Times).

Further information can be found at the CBC, Associated Press or The New York Times.

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