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Report: FDA struggles to monitor pharmaceutical ads

By ASSOCIATED PRESS
Published December 14, 2006

WASHINGTON - Regulators are issuing fewer citations to drug companies for false and misleading advertisements and are taking longer to do it, a congressional report says.

With annual spending on direct-to-consumer drug advertisements at $4.2-billion and growing, the government has limited ability to curb distribution of ads that violate federal rules, according to the report being released today.

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.

From 1997 to 2001, before FDA lawyers began reviewing the letters as a matter of policy, it took just two weeks on average to issue the letters. The number of letters fell off by about half between the two time periods.

When the FDA did send out letters in 2004 and 2005, it did so eight months on average after the flagged ads first appeared. At that point, more than half the ads were no longer in use, according to the report from the Government Accountability Office, the investigative arm of Congress.

The GAO also said the FDA lacks an effective way to screen, review and track the more than 10,000 ads and Web sites brought to its attention each year.

The Health and Human Services Department, the FDA's parent agency, acknowledges that the FDA's six reviewers cannot 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 rest on a more solid legal foundation.

[Last modified December 14, 2006, 01:37:07]