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MERRELL DOW PLANNING Rx DIRECT CONSUMER ADS IN WAKE OF FDA DECISION SEPT. 9 TO LIFT VOLUNTARY MORATORIUM; HILL OVERSIGHT COULD FOLLOW

Executive Summary

Merrell-Dow is planning an Rx advertising campaign for consumers to take advantage of FDA's Sept. 9 decision to withdraw its request for a voluntary moratorium on consumer ads. The company reportedly has already discussed a direct ad campaign with FDA. Merrell has two new Rx products ideally suited for consumer advertising. The company's smoking deterrent Nicorette is a logical choice for the initial ads based on the company's existing "Quit" informational promotion campaign and the consumer-driven demand for the product. Merrell also has the new Rx antihistamine Seldane on the market as a potential subject for consumer ads. The "Quit" smoking campaign has essentially been an Rx consumer ad without a product name and warning material. In recent ads, Merrell has advised "Now your doctor can provide a treatment to help control nicotine withdrawal symptoms, materials to help you overcome the psychological and social factors, plus valuable counseling and follow-up." The "Quit" campaign has appeared in wide-circulation magazines such as Time. Until now, Merrell has avoided mentioning that a drug product was available to help stop cigarette smoking. Merrell's approach has been to stimulate the patient to contact an MD for help in cutting back on smoking. FDA gave the drug industry the go-ahead for direct-to-consumer advertising in a Sept.9 Federal Register notice. Withdrawing its September 1983 request for a voluntary moratorium on direct advertising, FDA said it has "concluded that, for the time being, current regulations governing Rx drug advertising provide sufficient safeguards to protect consumers." The agency noted that in most cases "with certain exceptions" Rx consumer ads will be required to carry the standard brief summary warnings which appear in ads to the medical professions. "Although consumer-oriented advertising via electronic and print media is permitted, law and regulations governing prescription drug advertising require, with certain exceptions, a brief summary of all necessary information related to side effects and contraindications in any advertisement that promotes a drug for a particular use." The brief summary material is an obvious disincentive to broad advertising because of the added cost of extra pages and the possible communication problems caused by the medical jargon. In further smoking cessation ads, Merrell could avoid the brief summary by refraining from using the drug name and by emphasizing that a new Rx drug is available to help reduce smoking. Because of its unique position in the Rx smoking deterrent field, Merrell may be able to increase its direct ad support for Nicorette without running product-specific ads. The Nicorette campaign is a natural for Merrell. A Seldane campaign would be more significant to the rest of the industry as a test of an Rx drug company's attempt to distinguish a new product from a familiar existing class. If Merrell can convince consumers that a non-sedating Rx antihistamine is a significant improvement over existing OTC items and that the difference in the products is worth a trip to an MD, it could be a key sign of the potential of direct ads. FDA is likely to face continued opposition from Congress to direct-to-consumer Rx ads. House Energy & Commerce/Oversight and Investigations Subcmte. Chairman Dingell recently put the agency on notice about his concerns. Dingell wrote FDA Com. Young earlier this summer that "mass promotion of Rx drug products is not in the public interest" ("The Pink Sheet" Aug. 26, T&G-1). Indicating Hill interest in the role of White House influence on the direct advertising issue, Dingell requested from FDA all documents and correspondence on the subject since Oct. 5, 1984, as well as a detailed description of all communications between FDA and HHS and between FDA and the Office of Management and Budget (OMB). In October 1984, Dingell's staff released a report on Rx direct ads which was intended to maintain pressure on FDA to prevent consumer ads. The report maintained that there was a "virtually uniform negative reaction from the pharmaceutical industry, government, physicians, and consumer representatives" with regard to consumer ads ("The Pink Sheet" Oct. 15, 1984, p. 3). The Hill report included the results of a survey which found that only Merrell Dow, Sandoz, and Purepac explicitly favored direct ads. In a July 1984 letter to Dingell, Merrell Dow VP-Public Affairs Robert Ingram said there are "limited applications for some form of consumer advertising that might be acceptable." Ingram specifically mentioned Nicorette and Seldane as examples of products which might be advertised to consumers. While ostensibly rejecting consumer ads, several companies responding to the Dingell survey in 1984 indicated support for forms of promotional contact with consumers. Bristol-Myers, for instance, expressed support for either public service messages that encourage patients to visit their physician if they have certain symptoms or ads that are economically oriented. Bristol objected to ads which try to convince consumers of the merit of a particular Rx product on the basis of safety, efficacy, or convenience. Merrell outlined a series of guidelines for consumer ads in its 1984 letter to Dingell. The company said at that time that acceptable Rx consumer advertising: (1) should not mention a drug by name -- - therapeutic class designation would be more acceptable; (2) should reinforce the role of the physician or other health care professional in diagnosis and drug choice; and (3) should conform to the approved product labeling and provide precautionary information where appropriate. Sandoz and Purepac, the other two companies which expressed support for Rx ads in the Dingell survey, say they are not currently planning any consumer ad campaigns. Hoechst-Roussel, which recently ran a campaign discussing intermittent claudication, reports no plans to test Rx ads.

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