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SANDOZ, MERRELL DOW, PUREPAC ARE ONLY COMPANIES FAVORING Rx ADS TO CONSUMERS ACCORDING TO DINGELL SUBCMTE. REPORT; "IDEA WHOSE TIME HAS NOT YET COME"

Executive Summary

Sandoz, Merrell Dow and Purepac are the only companies, out of 32 drug firms surveyed, to favor Rx drug advertising to consumers, according to a staff report by Rep. Dingell's (D-Mich.) Oversight & Investigations Subcmte. The report culminates a two-year review of the issue of Rx drug advertising to consumers. In an Oct. 5 letter to FDA Com. Young describing the report, Dingell noted there is a "virtually uniform negative reaction" from the pharmaceutical industry, govt., physicians and consumer representatives with regard to such advertising. "The staff has concluded that, fortunately, mass promotion of Rx drugs is an idea whose time has not yet come," Dingell stated. "The industry's expressions on the subject are decidedly negative as its members contemplate the increased expense, govt. regulation, and exposure to product liability actions that such marketing activity would bring. The reactions from physicians' and consumers' representatives, and from many in the govt., is that such advertising would not benefit the public." In formulating the report, Dingell sent a letter to 27 major brand name drug companies, of which 26 responded, and 10 major generic companies, of which six responded. "Of the 32 respondents, only three, Sandoz, Merrell Dow, and Purepac, were willing to state that they believed advertising to consumers would be beneficial to the company, purchasers of their products, the medical community, or the public in general," the report says. Twenty-four companies stated that they did not believe the practice would be beneficial. The report charged five companies with fence sitting. "The remaining five, Pfizer, Ciba-Geigy, Norwich-Eaton, Merck, and American Cyanamid, waffled -- either not yet being sure, or wanting to study the issue more," according to the study summary. While the congressional summary of the survey responses concludes that there is a strong anti-advertising feeling within the industry, a closer look at some of the responses reprinted in the report indicates a gray-area of support for increased consumer contact by the drug companies. Merrell-Dow gave the most detailed explanation of the positive view of Rx drug advertising. The firm, in fact, described how it could conceive using consumer advertising to help launch the new non-sedating antihistamine Seldane (terfenadine). Pointing out that Seldane is part of a new generation of non-sedating antihistamines, Merrell maintained: "Advertising which allerted allergy sufferers that a new medication was available without referring to it by name, could provide an educational service. Company identification within the advertisement would also be acceptable." (See text, page 5 for Merrell-Dow's pro-ad arguments.) Bristol-Myers, one of the companies counted in the report tabulation as flatly opposing direct advertising, made a distinction between different forms of communicating with the public. Bristol's support for one of those forms of contact puts it in a position not too far from Merrell's stance characterized as pro-advertising. Bristol divided contact with the consumer into three categories: public-service; economically-oriented, and product-selling. The product-selling type is defined by Bristol as having the objective of trying to "convince the patient of the merit of a particular Rx drug on the basis of a safety, efficacy or convenience issue." Bristol stated a firm objection to that form of contact. Bristol, however, expressed support for the other two forms of direct contact. For example, for public service messages that "encourage patients to visit their physician if they have a certain symptomatology," Bristol declared: "It is clear that the medical community and public benefit." Increased consumer awareness of symptoms, Bristol said, "will benefit the pharmaceutical industry through increased drug usage and will benefit the public; not only through better medical care, but through the cost benefits of preventing the progression of untreated disease." Similarly, Roche distinguished between product-oriented promotional communications and patient educational materials. "In referring to patient education," the company said, "we have in mind information communicated to the patient. It is designed to inform and educate patients about particular medical conditions and alternative courses of treatment, including various types of drugs. Its goal is not to evoke a desire to purchase a particular drug but rather to enlighten a patient on a particular disease." Roche maintained: "Such information may be product-specific, related to a therapeutic class of drugs, or be entirely disease-oriented." Future Regs, If Necessary, Should Prohibit Broadcast Ads And Specify Print Content In response to Dingell's inquiry whether companies would respond in kind to competitor-initiated Rx drug advertising to protect their market position, the study found that a "high percentage of the respondents would not rule out answering in kind" if a direct competitor successfully broke the ice. The report concludes that if such advertising materializes, "it should not be judged against standards designed to measure the legality of advertising Rx drugs to physicians." The report states that future regulations, if they become necessary, should prohibit broadcast advertising of Rx drugs, specify the quality and quantity of information to be included in print advertising, and establish a standard "to ensure that whatever information is required to be included is actually communicated effectively." Noting that a prohibition of broadcast advertising raises Constitutional issues, the report says FDA "could argue that, by its very nature, Rx drug advertising to consumers in the broadcast media would be inherently misleading and, therefore, not Constitutionally protected." With respect to who should have jurisdiction over regulation of Rx advertising, the report states that FDA "is the one agency to control these promotional efforts effectively if they are to begin at all," since FDA is the licensor of industry products and its ability to request a product seizure has an "in terrorem effect" that gets an intransigent company's attention. The report also points out that the Federal Trade Commission "lacks a continuing institutional expertise in pharmacology" and must rely on outside assistance in dealing with drug advertising cases. In his letter to Young, Dingell said FDA "is to be commended for convening those involved in a number of open forums and for facilitating the expression of opinion from all sides. Both you and the pharmaceutical industry are also to be commended for imposing and respecting the voluntary moratorium on mass promotion so that the issues could be explored in advance." He noted that Congress "will not acquiesce in failure to move swiftly to ensure effective consumer protection if industry members succumb to the lure of mass promotion."

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