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Executive Summary

REP. DINGELL ASKING FDA TO STATE Rx DIRECT TO CONSUMER AD INTENTIONS and to provide a copy of agency records pertaining to the issue developed since last fall. In an August 22 letter to FDA Com. Young, House Energy & Commerce/Oversight & Investigations Subcmte. Chairman Dingell (D-Mich.) asked FDA to provide "a statement of the current or planned agency activities regarding prescription drug advertising to comsumers." Dingell also asked Young to supply "copies of all books, records, correspondence, memoranda, papers, and documents within the FDA relating to the issue prepared since Oct. 5, 1984." Dingell explained to Young that his request for records was prompted by reports that the agency is about to make a "shift of position on this most important issue." The Michigan Demo noted that on Oct. 5 last year, he had sent a copy of his subcmte.'s report on the direct to consumer ad issue to FDA. The letter reminded Young of Dingell's conclusion at that time that "mass promotion of prescription drug products is not in the public interest." Dingell added that he believed that FDA "shared that view at that time:" According to reports reaching him now, Dingell said, FDA has now decided to allow such promotion through a waiver of its moratorium implemented over two years ago. The agency, in putting the moratorium in place, said that eventually it would produce guidelines by which tests of the direct to consumer ad concept might be designed and conducted. Referring to reports that the agency is now planning to open up the field by not restricting ads to consumers to just a test basis, Dingell said: "My surprise is that it is happening, if accurately reported, without the slightest notice to me or the subcmte. staff." Stating that reports say that the Office of Management and Budget, and not FDA itself, is supplying the impetus for the change in status of the direct to consumer ad issue, Dingell also asked Young to provide a "detailed description of all communications, oral and written, between the FDA and the Dept. of Health and Human Service, and between FDA and the Office of Management and Budget regarding this issue." The direct to consumer ad issue could become the second recent agency action which conflicts directly with the positions held by key House members. On August 6, the agency issued a proposed rule to collect user fees for NDA/ANDA processing, a concept specifically rejected earlier by the House in passing an FDA appropriations bill Two Federal Trade Commission economists recently came out in favor of direct to consumer Rx advertising in the Aug. 22 New England Journal of Medicine. The economists, Alison Masson, PhD, and Paul Rubin, PhD, argued that consumer Rx advertising would lead to "improved matches between patients and drugs" and to a possible lowering of drug costs to the consumer. Those assertions, the article maintains, are often disputed in support of not allowing direct to consumer Rx advertising. The economists' article asserts that drug use might be improved for several reasons. Consumers might experience symptoms of a disease without realizing that it is a disease until exposed to the advertising, the article notes. As an example, the authors cite Pfizer's institutional advertisement which notes that thirst is a symptom of diabetes. "Yet Pfizer's incentive to undertake this type of informational campaign must be limited because Pfizer must share with other makers of hypoglycemic agents the demand-increasing benefits of the advertising for which Pfizer alone bears the entire cost." Drug costs to consumers might be lowered through advertising, the economists maintain, because consumers would be made aware of lower priced but equivalent products. Increased competition brought about by advertising, both by the drug firms and retailers, might also lower prices, Masson and Rubin noted. In addition, noting that both advertising and detailing are expensive, the authors state that "relaxation of the constraint on direct consumer advertising would allow manufacturers to allocate their marketing resources more efficiently," which would then be reflected in prices.

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