GAO Tells the FDA to Work Harder on Direct-to-Consumer Advertisement Issues

by Patricia Green, published on 12/18/06 by MedsAbroad.com

In 2004, the GAO (General Accountability Office) told the FDA, specifically the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), that they needed to fix a bottleneck that had formed when the DDMAC was told by Health and Human Services (HHS - the authority which oversees the FDA) in 2002 that they needed to have all the regulatory letters to drug companies reviewed and approved by the FDA's Office of the Chief Counsel (OCC) before they're issued. These letters are used to tell the drug companies that their direct-to-consumer (DTC) advertisements are in violation of regulations. The OCC sat on these letters for up to eight months before they were issued, which made them pointless in about half of the cases as the drug companies had moved on to other advertising in the meantime. Even when the letters were issued and drug companies removed the offensive material, they often later went back to that material in subsequent advertisements for the same drug.

The latest GAO report gives figures on how much is spent by drug companies on their DTC advertising, as compared to their advertising to doctors and the money they spend on research and development. DTC is the lowest amount of the three, by far, but it has increased by 20 percent per year from 1997 through 2005. This is in sharp contrast to drug promotion to doctors and research and development, each of which increased by 9 percent annually over the same period.

How effective is the DTC advertising? The GAO report says, "…while DTC advertising increased prescription drug spending and utilization, it can have both positive and negative effects on consumers. The studies we reviewed found that increases in DTC advertising have contributed to overall increases in spending on both the advertised drug itself and on other drugs that treat the same conditions." Further on they say, "The surveys we reviewed found that between 2 and 7 percent of consumers who saw DTC advertising requested and ultimately received a prescription for the advertised drug." That's fairly effective.

The FDA complains of manpower shortages which prevent it from being timely in its regulatory investigations of the DTC advertisements. But the GAO insists that this is a bogus excuse. Basically, the GAO suggests that the FDA is disorganized and doesn't prioritize the material well. They say, "…the agency cannot ensure that it is identifying and reviewing the highest-priority materials."

Direct-to-consumer advertising can be informative, but we are relying upon the FDA to make sure that this information is accurate and truthful. It is worrisome to think that the drug advertisements we are so often seeing may be giving us information that is wrong. If they're telling us wrong information, are they also giving wrong information to our doctors? The FDA needs to (1) get their act together and get organized where the DTC advertising reviews are concerned; and (2) break the bottleneck at the OCC that slows down needed regulatory letters.

Return to list of articles by Patricia Green