GAO Blasts FDA on Drug Ads

NEW YORK The U.S. Government Accountability Office issued a blistering report Friday that accuses the Food and Drug Administration of failing to protect patients from misleading drug ads.The report, commissioned by Sen. Bill Frist (R-Tenn.) when he was the Republican leader of the Senate, states that FDA's ability to halt misleading advertising is "limited," that it has failed to stop repeat offenders and that it has no consistent system for policing drug advertising.If the FDA discovers drug ads it believes are false or misleading, it issues warning letters to companies. The letters are almost always obeyed.Although the GAO has a policy of writing its reports in the most neutral, objective terms possible, its criticisms seemed doubly harsh because the GAO chastised the FDA for similar reasons in an account in 2002. As GAO's most recent report archly put it, "These issues are not new."A representative for the FDA accepted some parts of the report but challenged others, such as the claim that FDA enforcement was inconsistent.After its investigation of the FDA and the direct-to-consumer drug advertising business, the GAO found:--The FDA has inconsistent criteria for evaluating drug ads and therefore "cannot ensure that it is identifying or reviewing those materials that it would consider to be the highest priority."--The FDA is too slow in taking action against misleading drug advertising. "The 19 regulatory letters FDA issued from 2004 through 2005 were issued an average of 8 months after the violative materials were first disseminated to consumers," the report states. By contrast, "it took an average of 2 weeks to issue a letter [warning companies to remove misleading ads] from 1997 through 2001."--The system has gotten slower because in 2002 the FDA changed its policy to require all warnings to proceed via its general counsel's office. "The 2002 policy change had adversely affected FDA's ability to enforce compliance with its regulations by delaying the issuance of regulatory letters and potentially allowing misleading advertisements to continue to be disseminated," the report states.--The FDA has only seven staffers looking at the more than 10,000 pieces of DTC advertising submitted to the office each year. Thus, the FDA only "reviews a small portion of the DTC materials it receives, and the agency cannot ensure that it is identifying for review the materials it considers to be the highest priority."--When then FDA does get a warning out, it's often moot. The report states, "Drug companies had already discontinued use of more than half of the violative advertising materials."--The FDA is failing to stop repeat offenders, the report states. "Of the 89 drugs for which FDA cited violative DTC materials from 1997 through 2005, 25 drugs had DTC materials cited in more than one regulatory letter, sometimes for similar types of violations," the study says.The GAO recommended that the FDA develop formal, consistent guidelines for ad review, and that it act to reduce the amount of time it takes for such reviews to lead to warning letters.In response, the U.S. Department of Health and Human Services, which oversees the FDA, said the GAO's recommendations would require a vast increase in its staff.In addition, "The suggestion that [the FDA] does not consider DTC materials that should have the highest priority is incorrect," said Vincent Ventimiglia, assistant secretary for legislation, DHSS, in a statement. The FDA "reviews all final and draft broadcast ads because these have the greatest potential impact."

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GAO Blasts FDA on Drug Ads

Jim Edwards

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