DRUG PROMOTION IN "GUISE OF SCIENTIFIC EXCHANGE" IS FDA's TOP PRIORITY FOR DRUG ADVERTISING DIVISION, KESSLER SAYS; GUIDANCE WILL BE OUT "THIS YEAR"

Drug promotion in the "guise of scientific exchange" is FDA's top priority in the drug advertising area, Commissioner Kessler asserted at the Drug Information Association's annual meeting June 17 in Washington, D.C. "I have asked Anne Witt, the new acting director of [the division of drug marketing, advertising, and communications] to pay special attention to one particular concern: promotion in the guise of scientific exchange," Kessler said. "The current excesses must stop." Kessler promised that a guidance on science educational activities will be "in place by the end of the year -- this year." The agency is "in the final stages of preparing a draft policy," Kessler said. "Before adopting a final policy, however, we will seek the advise of industry, consumers, and the medical community." In the interim, FDA expects firms to refrain from promotions through seminars. Kessler warned the DIA audience: "I do not expect companies to wait until this guidance becomes final to put their advertising and promotional houses in order." "The sheer volume of prescription drug promotional activities concerns me," the commissioner added. Using figures compiled for Sen. Kennedy's December promotion hearings, Kessler said "16 companies sponsored 34,000 symposia during 1988 -- at a cost exceeding $ 85 mil." compared to 7,000 symposia costing $ 6 mil. in 1974. "Non-traditional promotional techniques that rely heavily on researchers and medical experts" may not be "inherently wrong," Kessler continued, but "FDA is seeing several drawbacks in their current, 'real world' application." Such techniques "blur the distinction between promotion and legitimate scientific exchange" and so could "dilute the quality of scientific discourse," he said. In addition, "these practices can mislead the medical community and, ultimately, the public." Finally, "the inappropriate use of promotional tactics can give unscrupulous firms an unfair market advantage." Kessler outlined the "broad directions" that the FDA guidance will take. He listed four factors FDA would consider to determine if a symposium is in fact an illegal promotion: independence, objectivity, balance, and scientific rigor. "I would expect that 'independence' under such a policy would mean that the sponsor of a symposium would not be able to exert control, implied or expressed, over the content of the program," Kessler said. "Objectivity" suggests that presentations "are objective and not promotional in tone . . . 'Balance' would suggest that a variety of legitimate medical opinion be represented," he said. Finally, "scientific rigor" suggests that only "reliable data" is presented. Because "FDA can never anticipate every possible promotional scheme" with a policy statement, Kessler said, "I would suggest that it would be prudent for industry to watch FDA's stance on the promotion of all products." He reminded the meeting of FDA's recent enforcement actions involving food labeling and of his personal commitment to "clear and accurate labeling." For drug promotions, Kessler said, this translates to "three principal requirements": that "they be true and not misleading"; that "they provide 'fair balance'"; and that "they do not promote unapproved uses." Kessler cited three examples of promotions that cross the lines on these rules: Collagen Corporation's "frank promotion of collagen injections for unapproved uses," Johnson & Johnson's "promotion of Retin-A to prevent wrinkling," and Ciba-Geigy's use of "a former star athlete," Mickey Mantle, to promote Voltaren. The first two were discussed before Rep. Weiss' (D-N.Y.) Government Operations/Intergovernmental Relations Subcommittee on June 11 ("The Pink Sheet" June 17, p. 7). Mantle's promotion of Voltaren was discussed by Kessler at a press briefing in March ("The Pink Sheet" March 4, p. 3). "You have my word that we will go about this task in a way that legitimate, responsible pharmaceutical firms will have no difficulty accepting," Kessler said. "We do not seek to interfere with innovations in the way legitimate information about new products is conveyed. I am acutely aware that the FDA has a responsibility to foster the availability of useful and accurate information." However, Kessler said, "selected promotional practices have, to be blunt, gotten out of hand. The current situation requires action." While continuing to take a hard line position on promotion, Kessler added an acknowledgement of the new product approval side of FDA's responsibilities. Kessler has been highly successful at reinvigorating the agency's enforcement image; the challenge for him now will be to maintain a balance in emphasis on the product review activities. Kessler's talk at DIA was preceded by comments from his former boss, Sen. Hatch (R-Utah), who warned that if FDA becomes "exclusively an enforcement agency" he will "begin to cut" his support for the agency. The FDA commissioner stressed three areas of product review "which, in my view, require attention." They are: * Consistency: "FDA needs a greater degree of consistency in what it requires of drug sponsors." Expanding the computer- assisted NDA pilot program and using advisory committees more uniformly are two specific actions the agency will look at, Kessler said. * Decentralized decisions: FDA "needs to empower capable scientists and reviewers -- at all levels -- to make decisions," Kessler said. He pointed to the recent announcement that the oncologlic drugs division director can sign off on new cancer drugs as an example ("The Pink Sheet" June 10, T&G-2). "No one should underestimate the importance of this change," he said. * Firmer timetables: FDA "needs to give industry a better sense of our projected timetables for product review." This will allow industry to "be able to plan more efficiently for the manufacture, production and launching of its new products." Kessler implied that the drug industry may be surprised by more timely reviews and may have to prepare to react to them. Kessler told an anecdote about an unnamed "senior manager in the pharmaceutical industry" who said he had received a call from FDA "simply to report that, within 12 months, the agency would complete its review of an NDA submitted by the firm." The company "didn't know what to do," Kessler said, "Its manufacturing plans for the drug were not ready. In essence, the firm had to scurry around to catch up with FDA."