Direct-to-Consumer Oversight Faltering, Says GAO

Once again, the US Food and Drug Administration is under fire for not doing its job. This time the issue is direct-to-consumer (DTC) advertising. According to a new Government Accountability Office (GAO) report, FDA only issued two regulatory or warning letters regarding DTC violations in 2007. Compare this with the 15–25 letters the agency sent each year between 1997 and 2001.

The reason for the change, says GAO, is an FDA-initiated protocol that went into effect in 2002. At that time, FDA decided to start sending all draft warning letters regarding DTC violations through legal review before sending the letters out to companies.

In November 2006, GAO issued a report noting that FDA’s new protocol was leading to delays in issuing regulatory letters for DTC violations. What took two weeks from 1997 to 2001, took an average of four months between 2002 and 2005, and last year, took an average of five months. In 2006, GAO recommended that FDA issue letters more quickly and also implement a better tracking system for prioritizing DTC materials upon receipt.

DTC advertising materials have been on the rise over the past few years. According to GAO, FDA received approximately 6000 such submissions in 1999, and 21,000 in 2007. It’s FDA’s role to oversee that such materials, whether on TV, in print or on the Internet, are truthful and nonmisleading.

But, states the new GAO report, the agency “still does not systematically apply its criteria to all of the DTC materials it receives.”

GAO Director of Health Care Marcia Crosse testified to the House Subcommittee on Oversight and Investigations, part of the Committee on Energy and Commerce, on May 8, regarding the study’s findings. Overall, she said that not much has improved since GAO offered recommendations in late 2006.

 “The amount of time it takes to draft and issue letters has continued to lengthen,” said Crosse. “We believe that delays in issuing regulatory letters limit FDA’s effectiveness in overseeing DTC advertising and in reducing consumers’ exposure to false and misleading advertising.”

The fact that FDA has been unable to regulate DTC advertising effectively has brought up many questions, including whether or not DTC advertising should continue to be allowed. The United States is one of only two countries (New Zealand is the other) that still allow the practice.

Furthermore, FDA’s letters have not been very effective. According to the GAO report, for the six warning letters FDA issued in 2004 and 2005, the corrective advertising materials were initially disseminated more than 5 to almost 12 months after FDA issued the letter. One violative advertisement for an allergy medication ran from April through October 2004 before FDA issued a regulatory letter in April 2005; even then, the corrective ad was not released until January 2006.

Current law authorizes FDA to require companies to submit draft television ads up to 45 days before they are aired and to charge civil fines for violations of prescription drug DTC advertising. The agency, however, has not implemented such rules.

At last week’s hearing, House Oversight and Investigations Subcommittee Chairman Bart Stupak (D-Mich) said that if the US continues to allow DTC materials, additional limits on companies’ ads may need to be required.