FDAnews Drug Daily Bulletin

GAO Criticizes FDA Regulatory Letters on Violative DTC Ads

May 13, 2008

The FDA continues to be slow in sending warning or untitled letters to pharmaceutical companies that it suspects of violating direct-to-consumer (DTC) advertising rules, according to a report by the Government Accountability Office (GAO).

Last year, the agency took an average of six months to issue regulatory letters citing violative DTC materials, Marcia Crosse, head of the GAO’s healthcare division, told a House Oversight and Investigations Subcommittee last week. 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 — a policy for which there was no apparent need — 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 violative advertising materials identified in each letter,” according to the GAO report accompanying 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.”

Moreover, only two regulatory letters on DTC advertising went out in 2007 — one warning letter and one untitled letter — compared with 15–25 regulatory letters each year between 1997–2001, before the legal review policy. Meanwhile, the FDA “has received a steadily increasing number of advertising materials directed to consumers,” the GAO report said — approximately 6,000 in 1999 as compared with 21,000 in 2007.

The GAO report can be viewed at www.gao.gov/new.items/d08758t.pdf.