REP. DINGELL WILL "MORE CLOSELY" MONITOR Rx DRUG ADVERTISING FOR CONSUMERS, HE TELLS FDA; AD COALITION DROPS EFFORT TO RESEARCH EFFECTS OF CONSUMER ADS

Rep. Dingell (D-Mich.) has directed his House Energy & Commerce/Oversight Subcommittee staff to step up its vigilance of the growing practice of direct-to-consumer advertising of prescription drugs, the House Energy & Commerce/Oversight Subcommittee chairman told FDA on March 16.

In a letter to FDA Acting Commissioner Benson, Dingell said he has directed his subcommittee staff "to monitor more closely" developments in prescription drug ads for consumers. The congressman noted that the increased scrutiny of consumer-directed pharmaceutical advertising was prompted by a Scott-Levin Associates study indicating that there is "substantial consumer support" for such ads.

Dingell asked the agency to provide "the number of corrective actions taken by FDA in the area of advertising activities" since June 1983.

The Michigan congressman also asked for "any internal memoranda and/or documentation regarding FDA's policy on direct-to-consumer advertising." The letter notes that the subcommittee is "particularly interested in internal discussions regarding aqdequate provisions for dissemination." Dingell justified the subcommittee review of FDA's records on internal discussions in his assertion that "the agency has not formulated a policy statement on this matter."

* The Scott-Levin survey report indicates that more than 70% of consumers believe that direct-to-consumer ads for prescription pharmaceuticals are "an important educational tool," are "valuable," or provide "a source of reliable" health care information.

The survey also found that 17% of physicians have diagnosed a disease "as a result of a patient coming...for help and describing symptoms seen in an ad." In addition, 72% of physicians indicated that "in most cases" patients requesting an advertised product "did...suffer from a condition that could be treated with the drug requested."

Although the survey found that most physicians remain opposed to such advertising, fewer doctors were opposed in 1989 than two years earlier. The percentage of physicians indicating that the ads provide no benefits to consumers fell to 55% in 1989 from 63% in 1987. Similarly, the portion of prescribers indicating that consumer-directed promotions provide no benefit to physicians decreased to 67% in 1989 from 72% in 1987.

However, 60% of physicians surveyed said ads are "appropriate" if they do not mention brand-name products but only direct consumers to contact a doctor to discuss a specific symptom or illness. On the other hand, only 12% indicated that it is appropriate for ads to mention brandname drugs.

Dingell's letter to Benson indicates that the subcommittee may be gathering information to update its 1984 report on prescription drug ads for consumers. At that time, Dingell's subcommittee concluded that congressional hearings were not needed because FDA seemed disinclined to loosen its advertising regulations to allow widespread consumer advertising. Sounding a note of caution, the recent letter points out the report stated "that the subcommittee would act immediately to bring the appropriate parties before it [in hearings] should the FDA take steps to facilitate direct-to-consumer advertising or if certain industry members decided to commence advertising of prescription drugs to consumers."

The letter also notes that the Prescription Drug Advertising Coalition withdrew its request that FDA endorse a coalition plan to test the effectiveness of advertising to consumers via broadcast media. The subcommittee was informed that the withdrawal of the request "was prompted by the coalition's realization that FDA would not relax the rules to allow airing of prescription drug advertisements for research purposes," Dingell said.

In a Jan. 24 letter to FDA Office of Drug Standards Director Peter Rheinstein, MD, the coalition said it would "not at this time make any futher effort to obtain FDA approval for the University of Michigan/[Institute for Social Research] research project which we discussed with FDA last fall." The coalition is made up of 53 private organizations, including 14 pharmaceutical companies, a number of advertising agencies, media companies and all three major television networks. The group had initially focused its efforts on initiating the research project to determine the viability and appropriate format of consumer-directed prescription television ads.

The coalition's decision to redirect its efforts away from the proposed television ad study stemmed from a meeting with several top FDA officials last fall ("The Pink Sheet" Dec. 11, p. 14).

At that meeting, FDA's then Deputy Commissioner Benson told the coalition that FDA could not "make a favorable decision" on the proposal at that time. According to a PDAC memo of the meeting, Benson added that "even if [the group] were able to show that direct-to-consumer advertising increased consumer understanding, this would not necessarily mean that [such advertising] made a positive contribution to public health." Following the meeting, FDA created a working group to look into the issue of direct-to-consumer advertising of prescription drugs. Dingell has kept an eye on the coalition, and particularly the three networks, in their efforts to legitimize television advertising of prescription drugs and find a way around FDA's requirement of brief summary information in all brand-specific prescription drug ads.

In 1988, Dingell and two other subcommittee chairmen of his Energy and Commerce Committee House Health Subcommittee Chairman Waxman (D-Calif.) and Telecommunications Subcommittee Chairman Markey (D-Mass.) -- wrote to the heads of the three major television networks to caution them that Congress would not permit direct-to-consumer pharmaceutical ads. And last year, prior to FDA's scheduled meeting with PDAC, the Michigan congressman wrote then-FDA Commissioner Young to "remind" him of the oversight subcommittee's "long-standing" opposition to "the relaxation of standards associated with direct-to-consumer advertising."

The coalition's study was to have been conducted by the University of Michigan's Institute for Social Research under the institute's Survey Research Center Director Ronald Kessler, PhD. Originally slated to begin this year, the study was to have been based on consumers' response to three direct-to-consumer ads for prescription drugs ("The Pink Sheet" Sept. 25, 1989, p. 10). In the January letter to FDA, the coalition also noted that the group's research advisory committee "wishes to cooperate with the FDA working group in its study of direct-to-consumer advertising of prescription drugs and the regulation thereof." The committee particularly hopes "to explore with the working group whether there is a need for research projects on subjects of mutual interest," the letter states. "If the working group believes research projects could be useful to its work, the committee may be able to provide advisory assistance and/or funding."

Kessler and Coalition Secretary James Johnstone (of the Washington law firm Wiley, Rein & Fielding) met with FDA's Robert Temple, MD, Kenneth Feather, and Louis Morris, PhD, in late February to follow up the suggestion that the coalition work with FDA on future research considered appropriate by the agency. However, FDA did not indicate it is currently prepared to collaborate on any research on the issue. The coalition's is now waiting for the agency's working group to reach a consensus on Rx drug ads for consumers.