Direct-to-consumer Advertisements Would Be Reviewed Prior To First Use
The drug company AstraZeneca Plc has proposed that there be a mandatory FDA review of all direct-to-consumer ("DTC") advertisements for prescription drugs before the ad is first broadcast or published.
AstraZeneca made its recommendation during the FDA's November 1-2, 2005 public hearings on DTC advertisements. In written testimony submitted to the FDA in connection with those hearings, AstraZeneca said it has adopted the Pharmaceutical Research and Manufacturers of America ("PhRMA") guidelines on direct-to-consumer advertisements.
AstraZeneca's new proposal goes beyond the guidelines adopted earlier in 2005 by Pharmaceutical Research and Manufacturers of America ("PhRMA"). Those DTC ad guidelines, which take effect in January 2006, call for PhRMA's members to voluntarily submit new television ads, but not those intended for newspapers and magazines, to the FDA for review. Ken Johnson, PhRMA's senior vice president for communications, said the industry trade association has not taken a position on AstraZeneca's call for a mandatory FDA review of all DTC drug ads, including print advertisements. Mr. Johnson did comment that "[w]e certainly encourage our companies to go above and beyond the code, if they believe it will help them better educate and inform consumers".
At present, the drug companies are required by law to submit DTC ads for FDA review at the time of the first broadcast or publication, not before that point. Some drug companies have voluntarily provided their DTC ads to the FDA earlier. As part of the November 2005 public hearing, the FDA is considering whether the earlier review of DTC drug ads should be mandatory. Drug companies spent an estimated $4.1 billion in 2004 on DTC ads for their prescription drug products.
Peter Lurie, deputy director of Public Citizen's Health Research Group and a well-known pharmaceutical industry critic, pointed out that AstraZeneca's proposal comes with a caveat that could prevent any mandatory early review of DTC ads from happening. AstraZeneca'a proposal is predicated on the FDA conducting faster reviews of DTC ads submitted to the agency for approval. The FDA, however, is not able to speed up its DTC ads reviews because it is short-staffed, observed Public Citizen's Lurie. "In effect, it's an empty promise," Lurie said. "The [FDA's] drug advertising division has been drastically understaffed for decades, and there's no reason to believe that will change anytime soon."
In relevant part, one purpose of the FDA's early November 2005 public hearing was to consider whether the agency should revise its rules about how much risk information should be included in DTC prescription drug advertisements, and whether all consumer-directed advertisements should be reviewed by the agency before public use.
(Posted by: Tom Lamb)