Government Accountability Office Blasts FDA

Report Criticizes How Agency Handles DTC Prescription-Drug Advertising

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NEW YORK ( -- The Government Accountability Office has released a scathing report on the way the Food and Drug Administration handles direct-to-consumer prescription-drug advertising, saying the agency has issued fewer warning letters to pharmaceutical companies for false and misleading advertisements and is taking longer to do so.
Critical of the Food and Drug Administration's handling of DTC prescription drug ads.
Critical of the Food and Drug Administration's handling of DTC prescription drug ads.

The GAO report, requested by Sens. Bill Frist, R-Tenn., Herb Kohl, D-Wis., and Charles Grassley, R-Iowa, also said the FDA lacks an effective way to screen, review and track the 10,000 pieces of advertising generated by drug makers each year in what has become a $4.5 billion-a-year industry. The FDA has just six reviewers on staff.

Warning letters
Between 1997 and 2001, it took the FDA an average of two weeks to issue a warning letter or citation to drug companies that ran afoul of DTC ad guidelines. But as the category exploded, the FDA was unable to keep up. From 2002 to 2005, when FDA lawyers began reviewing the letters as a matter of policy, the report found it took the FDA an average of four months to draft, approve and send correspondence to drug makers -- and, the report said, in 2004 and 2005, those letters came an average of eight months after the ads first appeared.

Though drug companies still spent more on research and development than on marketing, the report found that DTC ad spending grew 20% each year between 1997 and 2005, while R&D spending grew an average of 9%.

The Health and Human Services Department, the FDA's parent agency, said the FDA focuses on ads with the greatest potential to affect public health, and that such letters are have 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.

John Kamp, executive director of the Washington-based Coalition for Healthcare Communication and a DTC advocate, blasted the GAO report, saying that measuring quality by measuring the number of warning letters is "silly."

Time for reform
"Clearly the GAO is not composed of experts in the advertising review process," Mr. Kamp said. "Better government oversight doesn't necessarily mean spending more money and adding more staff. It's time for FDA to reform the advertising review process to ensure that it is objective, predictable and social-science based. Once that's done, we can better determine how to efficiently and effectively administer the program."

In the wake of the report, Sen. Kohl is sending a letter to the White House to ask President Bush to give the FDA more money to review and regulate DTC.

"If we are serious about protecting the health of consumers in our country, then we need an FDA capable of reviewing DTC ads and taking swift action when necessary," said Mr. Kohl, who will become chairman of the Senate panel with jurisdiction over the FDA budget. "This report tells us that we're nowhere close to that goal."

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Ira Teinowitz contributed to this report.
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