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FDA’s POLICY TOWARD FAIR BALANCE/BRIEF SUMMARY IN Rx DRUG ADS NEEDS REASSESSMENT, COMMISSIONER KESSLER SAYS IN JAMA ARTICLE ON  PROMOTIONS

Executive Summary

Referring to the off-hour showing of the brief summary by cable television to meet the brief summary requirements, Kessler and Pines state that "Lifetime cable channel's scrolling of the brief summary in the early morning hours does little to inform those viewing the advertisement." Kessler further questioned the appropriateness of physician label information in consumer ads. "Some would even argue that a consumer advertisement that includes the brief summary is by definition inappropriate, since the information was written in a form to be used by physicians, not consumers," Kessler reasoned. A footnote to the article points out that it was accepted for publication before Kessler was nominated as commissioner. However, as the front-runner for the position since early in the spring, Kessler must have been aware that his article had the potential to define his viewpoint on the hot topic of pharmaceutical industry promotional practices in preparation for his tenure with the agency. In fact, the subject, timing and handling of Kessler's article contribute to a developing picture of the new FDA commissioner's political skill. Kessler is well aware that two top Capitol Hill figures are staking out positions on the promotional topic. Sen. Kennedy (D-Mass.) has the results of a 1989-1990 survey of promotional practices as a point of departure for hearings (see following story) and Rep. Dingell (D-Mich.) continues to express reservations about direct-to-consumer advertising. Against that background, it appears a smart move by Kessler to show interest in the topic of pharmaceutical promotions going into the FDA job and to use the non-confrontational forum of a medical journal to chart a middle-of-the-road position on the subject. The JAMA article also is timely coming two weeks before the AMA mid-year meeting where pharmaceutical industry promotional practices are one of the topics scheduled for discussion ("The Pink Sheet" Nov. 12, T&G-2). Overall, the Kessler/Pines article remarks that those "who question promotional activities need to recognize that they have value, are here to stay and will continue to be a major source of information about prescription drugs, but those who argue for further expansion of these activities, especially of direct-to-consumer advertising, must exercise caution. If a perception develops that the increase in prescription drug advertising and promotion is resulting in inaccurate and misleading information, then more aggressive regulation may result." However, they also note that the line between scientific exchange of information and promotion is "extremely fine," particularly at a time when "patients have access to the Physician's Desk Reference, when anyone can tune in to the Lifetime cable television channel, when almost every week major scientific studies are reported on the evening news, and when the National Institutes of Health and the FDA themselves sometimes seek to publicize their own research findings." Kessler and Pines state that "emphasis must be focused on the content of the information being conveyed. The statutory mandate that information not be false or misleading should continue to be the central focus of the agency." In "focusing agency priorities, it is important to recognize that there are times in a product's life cycle that should be subject to greatest scrutiny," the authors continue. "The launch of a new drug is an especially critical juncture -- opinions about the drug are being formed at this time -- and no matter how extensive the previous clinical trials, the adverse event profile of the drug is still incomplete." They also suggest that consideration be given to public health needs, particularly with regard to consumer advertising. "From a public health perspective, a pneumococcal vaccine aimed at those who are at high risk for the disease is very different from a drug with no unique properties." In an accompanying JAMA editorial, FDA Center for Drug Evaluation and Research Director Carl Peck, MD, and Office of Health Affairs Director of Medical Staff Peter Rheinstein, MD, comment: "The article makes some cogent observations." Peck and Rheinstein strongly concur on the review of the brief summary. "The need to revise the brief summary for use in advertising in a way that makes it readable and more useful is inescapable," the FDAers declare. Peck and Rheinstein further agree that ad content should be the central concern, not how it is delivered. They go a bit further than the Kessler/Pines article and say: "Once the manufacturer sponsors and exercises control [of promotional information], it is difficult to say that the material produced should not be subject to the usual regulatory requirements for prescription drug information." They note that FDA plans in "the near future" to issue revised guidelines on direct-to-consumer advertising, industry sponsorship of continuing medical education meetings and press releases. Kessler's political skills and contacts are also evident in the credits to the article. Among the individuals to whom Kessler and Pines say they are indebted for help on the article are Rep. Waxman's top aide (and former Health Research Group lawyer) William Schultz and Sen. Hatch's top aide Nancy Taylor. Sen. Kennedy's former staffer Stephen Keith (Merck) also is cited, as is FDA Ad Division Director Kenneth Feather. Kessler's wife, Paulette Kessler, (Columbia, BA, Yale, JD) also contributed to the article. The collaboration with Pines, however, may carry one untimely association for Kessler. Coincidentally with the publication of the JAMA article, Rep. Dingell's staff released more material on FDA's handling of the Shiley heart valve. Included in that material was reference to a memo from Pines to Pfizer in 1985 on a series of meetings with James Benson, then a top official in FDA's Center for Devices and Radiological Health and now FDA deputy commissioner. The Dingell staff is apparently pursuing the contact between Pines and Benson as a sign of undue influence by Pfizer on FDA's handling of the Shiley heart valve problems. Pines was a logical co-author for the article on promotions. He is a well-recognized expert on publicity issues in the FDA area. He was an FDA associate commissioner for public affairs during the tenure of Donald Kennedy and Jere Goyan, and was edged out of the agency by the Reagan Administration for being too aggressive in the agency's promotional efforts in disputes with FDA regulated firms. "CONTENT" OF PROMOTIONAL INFORMATION IS THE KEY [From the summation of the Nov. 14 Kessler-Pines JAMA Article] "Misleading information can result if the sponsorship is hidden, if the drug's status is misidentified, or if the information is inaccurate or taken out of context.

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