IOM report scolds FDA, suggests DTC ban
The September Institutes of Medicine (IOM) report blindsided the FDA, scolding the agency for reliance on “the prospect of productive negotiations with industry” and urging it be granted “the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements,” including “distribution conditioned on specific warnings to be incorporated into all promotional materials (including broadcast DTC advertising)” and “a moratorium on direct to consumer advertising.” More precisely, IOM recommends a black triangle be used to designate new drugs for two years, and that DTC be prohibited for that period.
Other IOM recommendations, such as better funding for FDA drug safety efforts and solid leadership for the agency, have merit. But it was the proposed advertising ban and the “Get tough” talk that got much of the ink.
Steven Galson, director of the Center for Drug Evaluation and Research at FDA, was noncommittal on the specifics, but said “the spirit of the report resonates with many of us.”
On drug ads, he told Newsweek: “There are constitutional and other legal issues [to regulating drug ads], but we are looking at these policies and I know Congress is, as well. So there may well be changes.”
Galson testified to the good that DTC advertising does, but said: “There are potential negatives as well, such as people… convincing doctors to give them drugs they don't really need.”
Acting FDA commissioner Andrew von Eschenbach greeted the report with the equivalent of a limp handshake saying, “While considerable work has been done over the past two years to improve our approach to drug safety, work still remains to be done.”
The Coalition for Healthcare Communication and the American Association of Advertising Agencies responded coolly: “The group's specific proposal for a two-year DTC blackout clearly violates First Amendment protections of speech. Moreover, the use of a new drug symbol requires significant study and, if adopted, careful administration. And, of course, the First Amendment requires that any such technique be carefully tailored to insure that its intended outcome is effective, limited in scope, and not counterproductive.”
The New England Journal of Medicine chimed in on behalf of the IOM's prescription, as did USA Today, which wrote: “The ways to prevent another Vioxx debacle are well known. How many more reports will collect dust on a shelf before FDA and Congress act?”
The drug industry might wonder: How many reports extolling the public health benefits of and debunking common fears about consumer ads will go overlooked by critics for whom the facts don't suit their arguments? The exhaustive Prevention and FDA surveys firmly refute the suburban legends about advertising.
Just don't expect anybody to read them going into another election cycle.