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FDA PRECLEARANCE FOR PHASE IV PROTOCOLS, TO POLICE PROMOTION STUDIES, URGED BY EX-INDUSTRY EXEC JONES; VNRs SHOULD BE PRECLEARED, BARUCH PROF SUGGESTS

Executive Summary

FDA preclearance for Phase IV studies and video news releases were two of the suggestions for increased FDA authority raised at the Dec. 11-12 promotion and advertising hearings before Sen. Kennedy's Labor & Human Resources Committee. Retired industry exec David Jones urged the review of Phase IV protocols to look for studies designed primarily to support marketing claims. Jones maintained that the industry has developed a widespread use of post-approval studies as a means to "disguise promotion as research." "Perhaps the FDA should require pre-approval of all Phase IV protocols," Jones suggested in written testimony. "Phase IV studies were intended to generate valuable post-marketing surveillance to help us understand better how a drug works and how to manage adverse effects," the former public affairs specialist noted. "But Phase IV has now become just a device to camouflage promotion as research." Tracing the roots of Phase IV promotion studies, Jones recounted Ciba-Geigy's early success with a post-marketing campaign of promotional studies of Lopressor in the early 1980s. Jones noted that Ciba attempted to scuttle Merck's effort to enter the beta blocker class with a new post-infarction claim for Blocadren by running its own studies on the indication and promoting the studies prior to NDA approval. Jones indicated that Ciba's success in linking the new indication with the existing product was a bit of good fortune. The company did not begin its promotional studies, he maintained, until it thought it had enough information for an FDA supplemental application. However, the application was delayed by FDA requests for more information and the promotional studies carried the day in the marketplace. When the Merck product was approved, Jones noted, "cardiologists stayed with Lopressor." Promotion study expenses are included in research budgets, Jones told Kennedy. Asked how "companies bury their promotion expenditures," Jones responded: "It depends on what the marketing objective is. If it is pre-approval publicity prior to the time it gets on the market or a claim prior to the time it gets approved, then medical education will most always be budgeted somewhere in Phase III research." The studies are promotional in intent, Jones maintained, but they are charged to research "because the product has not yet been transferred to marketing. So it is still an R&D product. So all the communications associated with that product can easily be cross-charged into the R&D budget." Jones contended that type of accounting skews the industry data collected by PMA. "Those figures appear in the kinds of reports that PMA issues as expenditures for actual research, when they are not. They are promotionally related," he told Kennedy. More attention to video news releases was also urged by Jones and Baruch College marketing assistant professor Eugene Secunda. "FDA has recently said," Secunda reported, "that while new guidelines concerning VNRs are still in development, if such promotional material for branded ethical drugs is paid for and distributed by pharmaceutical firms, it would be regarded by the regulatory agency as labeling, and considered in much the same way paid advertising is now." Secunda speculated that "presumably, pharmaceutical companies producing VNRs to promote their branded prescription drugs will soon be encouraged to submit them to the FDA before distribution." In response to questioning from Kennedy on the regulation of VNRs, PMA President Mossinghoff indicated that new authority may not be necessary for FDA to act against unapproved uses promoted in VNRs. Citing FDA Commissioner Kessler's recent article in the Journal of the American Medical Association on promotions, Mossinghoff said: "Based on Dr. Kessler's article...it is clear that if a company produces a drug-specific video news release that has indications going beyond approved labeling, that is a violation of FDA regulations." Mossinghoff noted that control of VNRs is limited because of the media's prerogative to use them as they will. The VNR "is an effective modern press release," Mossinghoff said. "There are thousands of these used every year. The VNR is a press release...PMA puts out surveys of new drugs in development, and to do that we produce a VNR in connection with it. How that VNR is used is really up to the news organization; it's up to the station or the network how best to use it. Sometimes they use it as part of their program; sometimes they say, 'This is provided to you by the Pharmaceutical Manufacturers Association.'" Secunda and Jones both supported more disclosure of the sources of VNRs. Secunda said, for example, that "beyond the specific requirements of the FDA, it may be ultimately judged in the public interest that the federal government require that all use of such material be identified as emanating from a sponsored source, in much the same way 'file footage' is now voluntarily identified, with a super on the screen." Other suggestions for FDA authority at the hearing included...the required inclusion in labeling of a prominent acknowledgement of unapproved indications in cases in which companies receive a second regulatory letter for a promotion of an unapproved use (Jones); comparative safety and efficacy reviews (HRG Director Sidney Wolfe); and...civil penalties for FDA in cases of ad or promotion violations (Wolfe). Wolfe and Hatch agreed to the resource needs at FDA. Responding to a comment by Hatch on FDA's limited resources, Wolfe said the situation is particularly bad in the drug advertising division. "Whereas the budget has gone up some [at FDA in general]," Wolfe observed, "the part of the FDA that works on drug advertising and promotion is woefully understaffed, particularly now that it is being faced with new chores such as possible direct-to-patient advertising." The advertising enforcement effort, Wolfe said is "one part of the agency [that] needs to be targeted for more staff so that they can come up with more evidence. When I wind up being the person that provides them with a lot of the information on these gross cases, I know there must be something wrong because I spend only a part of my time doing it. I believe they only have seven people for the whole country for drug advertising."

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