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Executive Summary

FDA has not decided whether it will allow agency officials to attend National Association of Pharmaceutical Manufacturers meetings and what conditions the agency would place on the association, Acting Commissioner Benson told House Oversight Subcommittee Chairman Dingell (D-Mich.). Benson said that "no final decisions have been made regarding when and under what circumstances FDA will resume relations with the NAPM." However, he added, when FDA officials resume participation in the annual meeting of the generic drug makers association, the agency "will exert exclusive control over employees' travel and lodging arrangements," and FDA speakers "will not be permitted to make presentations at the beginning of the conference and then 'hold over' in order to participate in 'wrap-up' sessions." The agency letter includes answers to a series of questions posed by Dingell as a follow up to his subcommittee's Nov. 17 hearing ("The Pink Sheet" Nov. 20, p. 9). Benson's undated letter was released during the week of Feb. 5. An initial FDA response was sent to Dingell in January and returned as inadequate. FDA told Dingell that the agency "recognizes that the generic drug industry is a viable and important component of our nation's health care system." In order for the industry to understand changes in FDA drug regulation, "it is important to maintain a dialogue with generic drug manufacturers," Benson maintained. "Because NAPM represents a large number of generic drug firms, FDA participation at association-sponsored meetings and conferences is an effective means to communicate the agency's future initiatives regarding regulation of generic drugs." In a Dec. 5 letter, Dingell asked the agency why it would spend tax dollars to send government officials to a meeting where "informal" contact is made "with firms that have paid off FDA employees, falsified documents submitted to the agency, and/or been named as principals in the drug diversion scandals of a few years ago?" ("The Pink Sheet" Dec. 18, p. 12). FDA declined to attend NAPM's 1990 annual meeting during the week of Jan. 29, citing the problems over past subsidization of lodging expenses for FDA attendees. Benson also noted employees who received subsidies from NAPM have been instructed to repay them by March 30 or face disciplinary action ("The Pink Sheet" Jan. 1, T&G-4). In addition, "six memoranda of admonishment and three memoranda of reprimand have been issued," he said. "In one case, an individual is also slated for reassignment and another employee has elected to retire in lieu of proposed removal action." In response to a separate line of questioning, Benson asserted that trips to India by FDA officials to advise Indian drug firms regarding ANDA submissions predated placement of that country on the U.S. list of unfair trading partners. A February 1988 excursion that included FDA's Bioequivalence Division Director Shrikant Dighe, PhD, and other agency officials occurred "prior to the time when India's policies and actions regarding protection of intellectual property rights became a matter of broad concern in the U.S. government," Benson said. Dingell had asked the agency to ensure that FDA officials "will cease any participation with countries such as India until they agree to respect U.S. intellectual property and cease discrimination against U.S. imports." In response, FDA notes that the agency is now abiding by federal guidelines established in late 1988 to restrict activities in India until that country adopts adequate intellectual property protections. However, the agency does acknowledge that it is currently involved in two programs in India: a U.S. Agency for International Development project to construct a national biologics quality control facility, and the 1985 U.S.-Indo Vaccine Action Program. In a Jan. 23 letter to NAPM Executive Director Robert Milanese, Benson urged the association to be "more sensitive" to the agency's ethical guidelines. Benson said he hoped that "in planning future meetings in which FDA participation is intended, NAPM will be more sensitive to FDA's travel rules...and to the high ethical standards that we believe are essential to uphold, especially in regard to the participation of agency representatives during interaction with the regulated industry."

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