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Executive Summary

FDA AD DIVISION WILL SCRUTINIZE PR FIRMS' PROMOTIONAL ACTIVITIES for unapproved drugs and unapproved uses for drugs already on the market, the division's acting director Ken Feather said at a Scott-Levin Associates Pharmaceutical Marketing Symposium held Nov. 10 in Washington, D.C. "Our position is that most company sponsored public relations activities dealing with their products can be considered to be promotional activities, which are subject to our regulation," Feather said. The ad division is "considering cases on which to begin to take regulatory action based on that position," Feather said. FDA's regulation of such promotions "will certainly be a developing area over the next number of years as we determine where our responsibilities and where our authority lie," Feather said. "We certainly will try to keep the industry informed of our positions, so that appropriate actions and responses and even complaints to these positions can be made." Feather pointed out that "whenever we hear the use of public relations techniques being used to disseminate information about drugs being discussed, it is usually in the sense of avoiding FDA regulation." There may not be direct statements to that effect, he noted, "but the inferences are all too clear in many cases." The public relations firm and/or sponsor may claim that such promotional activity is "either free speech or an exchange information," Feather said. It may be considered free speech when an investigator presents the results of his study at a seminar or at his own press conference, Feather noted. "However, when the manufacturer of the product, the sponsor of the research, pays to hold the press conference or pays for the investigator to travel around the country to present to seminars -- Is the scientist independent, or has he or she become an agent of the company?" Feather asked. "We think it is more likely the latter." Publicizing results of a small, short-term study for a new, but unapproved, use of a marketed drug for long-term use in a potentially large patent population might be acceptable if presented to a gathering of physicians as interesting information requiring further study, Feather pointed out. "But as a highly publicized campaign, which can do nothing but induce people to seek this drug for the unapproved use, it seems more like promotion," he said. During the Q&A session, Feather noted that a lot of misinformation about drugs is being disseminated, citing the example of one particular "newspaper video." The video shows an investigator discussing his study on a local news show and the use of the product for an unapproved use, Feather said. In that video, the investigator presents a film of a study subject using the product near his eyes. However, the product is contraindicated for use in the eyes, Feather said. "So that's the kind of information the agency is looking at and considering," he added. "There's lots of information that needs to be disseminated, but I think it has to be balanced. It has to be accurate, and ]it[ has to be truthful." One participant asked Feather whether or not FDA's current position on direct-to-consumer advertising would be supported by the Bush Administration. "There is a strong feeling within the agency against direct-to-consumer advertising," but "we have no intent to change the rules now," Feather responded. "If it's not illegal, ]and[ the agency has officially said it is not illegal, it can be done if you follow the rules, the rules that are currently in place."

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