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Executive Summary

The Pharmaceutical Manufacturers Association will explain the enforcement procedures for its new marketing guidelines to Sen. Kennedy by the beginning of February. Association president Gerald Mossinghoff committed to report back to Kennedy on enforcement procedures during testimony at the second day of the Dec. 11-12 marketing and promotion hearings. Asked by the senator whether PMA plans to enforce the new promotional guidelines, Mossinghoff replied: "I have not brought that [question] to the board of directors." He explained that the board was "moving pretty fast in adopting these AMA guidelines and that [enforcement] was not discussed at the time in New York" at the Dec. 6 board meeting. "I'd be pleased," Mossinghoff said, "to bring that to the executive committee of the board" and report back to the senator within 45 days. Kennedy suggested that an association enforcement plan will be necessary. He claimed that "abuses" have occurred while earlier guidelines were in force. He did not attempt to compare current marketing practices against positions taken by the PMA during the earlier round of hearings. During the first day of the hearings, the chairman asserted that the "principal question" for manufacturers and physicians and for Congress and the Bush Administration "is whether the industry and the medical profession can heal themselves or whether additional regulation or legislation is needed." During the second day, when the two associations testified, Kennedy said his "committee intends to monitor these reforms closely in order to determine whether the abuses covered by the guidelines are truly corrected." Holding up a copy of PMA's "Code of Pharmaceutical Marketing Practices," Kennedy noted that a previously existing passage stated that "scientific objectives should be the principal focus in arranging such meetings, and entertainment and other hospitality should not be inconsistent with such objectives." Turning to a newly added statement on symposia, Kennedy read: "Subsidies should not be accepted outside of modest meals or social events held as a part of a conference or meeting." The senator asked, "How does that [new provision] differ from" the earlier guides, under which "we've gotten into the kinds of problems that we've identified during the course of the hearings" and "which even you've identified in your opening statement? How does that tighten down on the types of abuses that we've seen?" Mossinghoff replied that "if there is any question at all, if these are subject to various interpretations, I would say that the AMA guidelines are the ones that control." Kennedy asked why the two codes were printed together. "You're distributing a pamphlet with the old ones and the new ones on it and representing that you're really trying to come to grips with some of the abuses...and I am somewhat confused as to which is the guidance," Kennedy said. Mossinghoff distinguished the positions on travel arrangements. "The major difference," the PMA president said, "is that...the IFPMA guidelines were silent with respect to companies paying for travel and accommodations for conferences. The AMA guidelines are very specific about the fact that doctors may not accept -- doctors who are merely attending a conference as opposed those making presentations or those who arrange the conferences -- but doctors who are attendees of conferences cannot accept travel or entertainment. That is now very specific in the AMA guidelines." Mossinghoff maintained that the voluntary marketing code previously established by the International Federation of Pharmaceutical Manufacturers Associations is "working very well." "More than 500 complaints" have been filed under the IFPMA code; such complaints "if they involve a PMA company are referred to me, I in turn refer the complaint" to the company's CEO or president, "and generally they are resolved within a week or two," Mossinghoff explained. There are "virtually no unresolved complaints under the IFPMA code," Mossinghoff continued. Therefore, "I firmly believe that the [new] voluntary code will work." Suggesting that a voluntary code will work better than enforceable regulations, Mossinghoff said the new code will continue to be "dealt with in a policy-management style as opposed to being some kind of a legally binding regulation, which involves the lawyers and regulators." Kennedy was skeptical: "For you as head of the PMA to suggest that if there's a violation you want FDA to enforce it, or we haven't had a single [unresolved] instance that has come before the PMA with regard to either ethical issues or inappropriate conduct by any of the members of PMA -- not a single instance -- then you have to really wonder what in the world your organization has been doing with regard to these kinds of instances." AMA's Daniel Johnson, MD, vice speaker of the House of Delegates, which on Dec. 4 adopted new ethical guidelines regarding industry gifts, testified that his association also had no plans for enforcement. However, Johnson noted, the guidelines will be adopted by state medical licensing boards and therefore become binding on physicians. Asked how many physicians have lost their licenses due to enforcement of the existing guidelines on conduct, AMA testified that the association "expelled 31 of its members for failure to meet its code of conduct." Kennedy requested a breakdown of the expulsions for criminal behavior and those for other types of violations of conduct.

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