GAO Report: DTC Getting Off Easy
Dec/14/2006 05:40 Filed in: Pharma
Business
Regulators are issuing fewer citations to drug companies for false and misleading advertisements and are taking longer to do it, a congressional report says. DUH ! With direct to consumer advertising over $4 billion and increasing and a small staff of reviewers just what is the FDA supposed to do?
From 2002 through 2005, it took the Food and Drug Administration four months on average to draft, approve and send warning letters and other correspondence to companies that were in violation of the rules, government auditors said. Between 1997 and 2001, before FDA lawyers began reviewing the letters as a matter of policy, it took two weeks on average to issue the letters. The number of letters fell off by about half between the two time periods.
The Government Accountability Office also said the FDA lacks an effective way to screen, review and track the more than 10,000 ads and Web sites brought to the agency's attention each year. The amount has doubled in four years.
The Health and Human Services Department, the FDA's parent agency, acknowledges that the FDA's six reviewers can't scrutinize everything so they focus on those ads with the greatest potential to affect public health. The department said the lengthy legal reviews give the FDA more teeth because the letters that are sent rest on a more solid legal foundation. "As a result, companies take our letters more seriously and quickly react to the problems identified therein," the department said in written comments to the GAO, the investigative arm of Congress.
Will this lead to more reviewers? Probably not but you can be sure that when Democrats take control of both houses that this report will be used against the FDA. The new head of the FDA is sure to be called in front of Congress to explain the the FDA's lack of oversight of DTC ads and websites. Changes are in store but for now the direction and scope of those changes are anybody's guess.
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