Lost in the Sauce

FDA is so snowed under by the drug industry's prolific marketing materials that its approach to nabbing rule-breakers amounts to little more than playing pin the tail on the donkey, a government report accuses. The study released last month fingers a 2002 policy change--intended to give FDA more teeth to police drug ads, but which made the agency slower, clumsier, and less efficient. It also calls on FDA to establish a system for prioritizing which marketing materials to review and for tracking them through the process.

Senators Herb Kohl (D-WI) and Bill Frist (R-TN) requested the report from the Government Accountability Office. Its findings may serve as extra ammunition for the new Congress as it attempts to add drug-safety reforms to a reauthorized 2007 Prescription Drug User Fee Act.

The 37-page report found that, compared to four years ago, FDA is issuing fewer warning letters to pharma companies that violate direct-to-consumer advertising rules, and is taking longer to send them out--so much longer, in fact, that about half of violators are getting warned about material that is no longer in circulation. "Given the length of time it takes FDA to issue regulatory letters and the potential for repeated use of violative claims, we are concerned about FDA's effectiveness at limiting consumers' exposure to false or misleading DTC advertising," wrote Marcia Crosse, GAO's director of healthcare.

The GAO blames a 2002 rule requiring FDA to have all warning letters approved by its Office of Chief Counsel, three attorneys who also have responsibility for a host of legal issues, including those relating to new drug approvals. Since FDA has little enforcement power of its own to act on ad violations, the policy was meant to warn manufacturers that the agency is willing to take legal action, when necessary.

But at the same time that the oversight process became more cumbersome--including back-and-forth negotiations between the DTC Review Group and the legal team before letters were sent--FDA saw a big jump in the number of ad materials it received. In 2005, reviewers faced a mountain of about 16,000 pieces of marketing material--nearly double what piled up on their desks three years earlier.

Of course, most of those materials--which range from prime-time broadcast spots to waiting-room brochures--never even get a perfunctory once-over. But GAO slammed the FDA for having no effective system either to prioritize which ad materials to review or to keep track of which--or even how many--pieces it monitors.

The Department of Health and Human Services (HHS), which oversees FDA, begged to differ. The agency claimed that it does have a system in place for prioritizing ads: It looks at broadcast spots first, since these have the largest audience potential, and then moves on to pieces that haven't run yet, as a way to stop problems before they start.

HHS also insisted that its enforcement efforts are about quality not quantity--and aimed at getting industry to voluntarily comply with its marketing rules. "Recognizing that the agency's credibility would suffer if it was considered a paper tiger, the department ultimately determined that a change was necessary and desirable," HHS officials wrote. "Instead of multiple letters, one letter now suffices."

FDA, however, does seem to be saving its bigger bite for the worst offenders. Of the 98 letters it issued from 1997 through 2001, only six, representing about 6 percent, were the most serious "warning letters;" in contrast, eight of the 37 letters (22 percent) issued between 2002 and 2005 were warning letters.

GAO also had a finger wag for pharma, noting that it takes an offender an average of five months to fix a violation, attributing the delay to lengthy compromise and negotiation between the company and FDA on new materials. About 42 percent of drugs receive multiple warnings for ads that continue to break the rules, it added.