EXPERTS: CDER FOCUS GROUPS INTENDED TO DELAY DTC REFORMS

The FDA's recent decision to convene focus groups to study potential changes to the agency's policy on direct-to-consumer (DTC) advertising is part of an FDA effort to stall reform while an interim commissioner heads the agency, according to industry experts.

The agency recently announced that it intends to conduct 20 focus group studies annually, with approximately 10 focus groups and 200 focus group sessions, focusing on DTC ads, physician labeling, risk communication and other topics. While the agency usually uses focus groups to develop new policies, experts following the DTC ad issue said the move will only act to delay the development of meaningful policy.

During a recent FDAnews audioconference, John Kamp of the Coalition for Healthcare Communication, and Peter Pitts, director of the Center for Medicines in the Public Interest, criticized the agency's decision. "Unfortunately, more research may be done in lieu of actual changes," Pitts said. Convening focus groups is the "FDA's way of doing nothing while saying something is being done," Kamp added.

It is especially unlikely that new policies will be implemented while the agency has an interim commissioner, Pitts said. However, acting FDA Commissioner Andrew von Eschenbach took exception to that notion, telling FDAnews, "I don't have the sense that there is something that I can't do because I'm acting. I haven't seen it as an issue yet.

"My title may be acting, but there is nothing acting about what I'm doing. I have the executive authority to implement policy," Eschenbach told FDAnews following a recent speech at the FDA/CMS Summit for BioPharma Executives in Washington, D.C. Eschenbach added that he would serve as the agency's permanent commissioner if the president asks him to.

Legislative action to change federal policy regarding DTC advertising is also unlikely at the current time, Pitts and Kamp said. Congress is too far behind in passing fiscal year 2006 appropriations bills to focus on the issue, Kamp said. However, a rider is a possible way to address the need for clearer DTC requirements, Kamp added.

Both speakers argued that new DTC policies are necessary to ensure that future regulation is not as subjective as it is now. Without firmer standards, companies will not know what they are allowed to do, the speakers said. "You can't regulate by opinion," Pitts argued, adding that the FDA needs to develop metrics to measure the quality of DTC promotions. Without set standards, the agency will be at greater risk of having its decisions overturned in court, Kamp added.

To obtain a copy of the "DTC Advertising and Promotion: Strategies for Adapting to a Changing Environment" audioconference on CD, go to http://www.fdanews.com/wbi/cds/2065-1.html.