I guess Big Pharma’s advertising is getting a little out of hand. According to MedsAbroad.com, a recent GAO (General Accountability Office) report stated,
the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) [said] a bottleneck … 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.
According to figures in the report, DTC advertising has increased 20 percent a year from 1997 to 2005. Forbes adds:
The U.S. Food and Drug Administration has issued fewer warnings to drug companies for false and misleading direct-to-consumer advertising and is taking longer to act on such infractions, says a Government Accountability Office (GAO) report released Thursday. Between 1997 and 2001, the FDA took an average of two weeks to issue warning letters to drug companies about ads that violate federal rules. Between 2002 and 2005, it took an average of four months to issue such letters, the report said. The GAO also found that the number of warning letters issued by the FDA fell by about half between those two time periods, the Associated Press reported.
Despite the recent influx of DTC advertising, the FDA has only six employees commissioned to review the incoming material.
1 response so far ↓
1 eDrugSearch Blog » Blog Archive » When it comes to drug ads, is the FDA the new MPAA? // Apr 23, 2007 at 1:35 am
[...] The FDA positions the plan as a toughening of previously lax regulations in response to public complaints about direct-to-consumer ads. The reality is, the projected $6 million in annual fees for FDA review would primarily serve to keep the drug ads coming at a blistering pace. As one observer sums up FDA priorities: [FDA officials] behave as if their job is to get as many “good products” to the American public as quickly as they can. The focus should be on public safety rather than on facilitation of the drug availability process. [...]
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