The report, titled, Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations, was requested by Senators Susan Collins (R-ME), Barbara Mikulski (D-MD), James Jeffords (I-VT) and Representatives Nick Rahall (D-WV) and Joe Hoeffel (D-PA).
According to GAO, while the FDA is generally effective at halting the dissemination of advertisements it identifies as misleading, the FDA's oversight of DTC advertising "has limitations." For example, the Division of Drug Marketing, Advertising, and Communications, within FDA's Center for Drug Evaluation and Research, reviews all broadcast advertisements because of the large number of people who will see them. The FDA issues regulatory letters for a small percentage of the advertisements it reviews. (From August 1997 to August 2002, the FDA issued 88 regulatory letters for DTC advertisements deemed in violation of FDA standards.) Pharmaceutical companies that have received regulatory letters usually ceased dissemination of the misleading advertisement. According to the GAO report, however, FDA's oversight has not prevented some pharmaceutical companies from repeatedly disseminating different, misleading advertisements for the same drug.
GAO also found that FDA is taking longer to issue regulatory letters to pharmaceutical companies. A decision by the Department of Health and Human Services for FDA's Office of Chief Counsel to review all draft regulatory letters has sharply reduced FDA's effectiveness in issuing these regulatory letters in a timely manner, according to the GAO. This means that misleading ads may remain on the air even after they are identified by FDA as misleading. Some regulatory letters may not be issued until after an advertising campaign has run its course.
"The report is troubling in that it shows us that the FDA is unable to keep pace with those pharmaceutical companies that are bent on bad faith advertising, while seeming to comply with the rules. We intend to highlight these limitations to the FDA and urge the agency to rectify the deficiencies in its current operations," said Senators Susan Collins (R-ME), Barbara Mikulski (D-MD), James Jeffords (I-VT) and Representatives Nick Rahall (D-WV) and Joe Hoeffel (D-PA). The five members of Congress will send a letter to the FDA detailing the report and urging remedial action in the areas cited by GAO.
The report also found that DTC advertising appears to increase prescription drug spending and utilization. Drugs that are heavily advertised to consumers often are among the best selling drugs. In 2000, 22 of the 50 drugs with the highest DTC spending were among the top 50 in sales. Moreover, sales of drugs with the highest DTC spending have risen more quickly than sales of other drugs.