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Executive Summary

REP. DINGELL REQUESTS FDA SPEECHES, MEMOS OF CONTACTS WITH NAPM when agency officials attend the first day of a regulatory-legislative conference of the National Association of Pharmaceutical Manufacturers, scheduled for June 7-8 in Washington, D.C. In a May 3 letter to FDA Acting Commissioner Benson, Rep. Dingell (D-Mich.) asked the agency to provide his House Energy & Commerce/Oversight Subcommittee "with complete texts of the remarks of all FDA employees addressing NAPM" during any association meetings held the rest of this year. The congressman also requested that "each FDA participant...log the time devoted to the preparation and attendance at the meetings" and also "keep careful notes of each private sector contact during the meetings (regardless how casual) and supply legible copies of such logs and memoranda of meetings to the subcommittee within seven days of the completion of NAPM conferences." The first day of the June conference will be devoted to regulatory issues affecting the generic drug industry, the second to legislative ones. Speakers scheduled for the second day include two members of the full Energy & Commerce Committee: Reps. Bliley (R-Va.) and Waxman (D-Calif.). Bliley, the ranking Republican on Dingell's Oversight Subcommittee, is an original cosponsor of generic-specific FDA enforcement legislation being introduced May 15 by the Michigan Democrat. Staff indicate that Bliley's speech is not likely to endear him to NAPM. Dingell suggested that FDA should not participate in the association's meetings. "There exists a basic principle of 'clean hands or hands off.'" Dingell contended. "NAPM has no claim to clean hands, and FDA officials should keep an appropriate distance from that trade association." The congressman previously had complained that FDA employees who attended NAPM annual meetings inappropriately had their travel and hotel accommodation costs subsidized by the association. Such subsidy presented an apparent conflict of interest, Dingell said. The fact that the June 7-8 meeting will be held in Washington "merely cures one of" the problems with agency participation in NAPM meetings, he maintained. "NAPM remains an organization which includes firms which have pled guilty, others which will undoubtedly be found guilty and others which were fortunate to avoid criminal charges in the generic drug and drug diversion scandals," the congressman contended. The letter describes the association as "a trade group of generic drug makers and pharmaceutical drug distributors, many of whom have figured prominently in either the generic drug scandal or the drug diversion scandal." Furthermore, "to the best of our knowledge, NAPM still shares offices with, and is represented by, the New York law firm of Bass and Ullman," Dingell continued. "As counsel to NAPM this law firm was responsible (by commission or omission) for the position that FDA employees could have their travel expenses and those of their families subsidized by NAPM." FDA participation in NAPM meetings is unnecessary, the letter continues, because the agency "has begun to publish carefully crafted guidelines for the approval of generic drug applications." There is "no reason to continue to engage in the questionable practice of 'regulation by speech,'" Dingell said. "If NAPM members are not sophisticated enough to learn how to properly apply for approval to manufacture drugs without relying on extensive informal extra-record contacts with [agency] officials, then they should not be receiving approvals." Furthermore, he added, FDA "hardly has the excess resources to devote to creating conference programs for any trade organization as it has historically done for NAPM." The letter acknowledges that "an occasional speech by an agency policymaker to a trade association, even one whose members are entirely dependent on the goodwill of that agency, may in principle be useful and appropriate." However, Dingell said, "the track record of conflict of interest that has defined the relationship between FDA and NAPM for over a decade makes your decision [to permit agency employees to participate in the June meeting] questionable on the grounds of appearance alone. For at least the past 10 years many FDA employees have been improperly subsidized, many to the tune of several thousand dollars each, to attend NAPM meetings." Dingell further suggested that the association's annual meetings were conducive to "ex parte contacts" between industry agents and FDAers that led to illegal agreements. "Raju Vegesna first provided Charles Chang with items of value -- free room and board -- at an NAPM meeting and began the association which ultimately led to their 'special relationship.'" Former FDA chemist Chang and former American Therapeutics' President Vegesna, respectively, have pled guilty to receiving and paying illegal gratuities.

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