AMA, GAO voice concern over direct-to-consumer ads, FDA oversight

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Direct-to-consumer pharma ads are facing national opposition. Source: CUPE National  

While the American Medical Association (AMA) called for better government oversight of direct-to-consumer advertisements (DTCA), the Government Accountability Office (GAO) is criticizing the FDA for being slow in sending warning or untitled letters to pharmaceutical companies that it suspects of violating DTCA rules.

Nancy Nielsen, MD, AMA president-elect, shared the association’s concerns about some DTCA, especially in regards to prescription drugs, in testimony to the House Energy and Commerce Committee Subcommittee on Oversight and Investigations May 8.

Last year, the FDA took an average of six months to issue regulatory letters citing violative DTC materials, Marcia Crosse, director of the GAO’s healthcare division, revealed during the meeting. In one case, the agency took more than three years to issue a regulatory letter, she said.

Before 2002, when the FDA decided that all draft warning or untitled letters had to undergo legal review, it took less than a month to send such letters, Crosse said.

The FDA has not improved since a 2006 GAO report found that “by the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the volatile advertising materials identified in each letter,” according to the 2008 GAO report that accompanied Crosse’s testimony.

“In addition, FDA’s issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs,” Crosse said.

Moreover, only two regulatory letters on DTC advertising went out in 2007—one warning letter and one untitled letter—compared with 15 to 25 regulatory letters each year between 1997–2001, before the legal review policy, according to the GAO.

Meanwhile, the FDA “has received a steadily increasing number of advertising materials directed to consumers,” approximately 6,000 in 1999 as compared with 21,000 in 2007, the GAO report stated.

“Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug's benefits than risks," said Nielsen. "Imbalances in these ads can diminish patient understanding of certain drug risks, and increase the need for an ongoing dialogue between patients and physicians about the benefits and risks of prescription drugs.”

At the hearing, the AMA stressed the need for FDA regulation over DTCA and shared guidelines for DTCA that address advertising content, disclosures and audiences targeted.

“The AMA guidelines for DTCA can help ensure that patients receive information about prescription drugs that is accurate, educational, well-balanced and encourages patient-physician communication,” said Nielsen. “We look forward to working with Congress to achieve our shared goal—that direct-to-consumer advertisements focus on truly helping patients rather than maximizing pharmaceutical companies’ bottom lines.”