GAO reports that FDA still lags in DTC violation warnings

WASHINGTON The Government Accountability Office has released a report stating that the Food and Drug Administration continues to lag in sending warnings or untitled letters to pharmaceutical companies that it suspects of violating direct-to-consumer advertising rules.

Marcia Crosse, the head of the GAO’s health care division told a House Oversight and Investigations Subcommittee last week that the FDA last year took an average of six months to issue regulatory letter citing “violative” DTC materials. 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 according to Crosse.

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 to 25 regulatory letters each year between 1997 and 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.