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Executive Summary

House Commerce/Oversight Subcommittee Chairman Dingell (D-Mich.) is holding FDA's feet to the fire to get a policy on whether agency employees may attend future annual meetings of the National Association of Pharmaceutical Manufacturers. In a Dec. 5, letter the congressman asked Commissioner Young to describe the agency's "policy regarding FDA employees' attendance at any future meetings" with NAPM. Dingell's subcommittee has held four hearings on generic drug approvals and regulation this year. "If FDA employees are going to be allowed to participate in NAPM meetings at government expense," Dingell said, "please explain the public policy purpose achieved which is sufficiently important to justify encouraging informal agency contact 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 congressman further asked whether those FDA employees who have benefited from travel and lodging expenses "improperly afforded to them" by NAPM have reimbursed the association. In addition, he asked whether those "who accepted over $ 20,000 in improper gratuities from NAPM" have been the subject of "administrative action," as recommended by the Inspector General. Suggesting that FDAers may have made efforts to aid applications by firms with ties to India, the congressman linked the generic drug issue with another investigation by his subcommittee: unfair trade practices. Dingell noted several FDAers traveled to India, "in part," to "provide technical assistance to Indian drug firms on how to acquire approval for the export of medicinal chemicals to the U.S." The letter states: "Not only does India not respect U.S. product patents for pharmaceuticals and chemicals, but that country has failed to provide U.S. firms with reciprocal access to its markets. In fact, President Bush . . . appropriately placed India on the Super 301 list of the most unfair traders." The subcommittee was informed that Bioequivalence Division Director Shrikant Dighe, PhD, "and several other FDA employees escorted as many as 15 pharmaceutical industry executives to India," the letter states, and "Dr. Dighe himself has made at least four different trips over the past five years." Dingell asked Commissioner Young what action will be taken "to insure that Dr. Dighe and other FDA employees 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." He also asked which firms, industry representatives, consultants and other FDA employees participated in conferences attended by Dighe. In contrast to the implication of guilt leveled at the companies and individuals attending the NAPM meeting, Dingell requested that FDA publicize the names of any generic firms that it believes are clear of misbehavior or serious regulatory problems. "Given the questions still hanging over the industry, firms which satisfy the FDA that there is probably no fraud in their ANDAs, have not been paying off FDA employees and are generally in compliance with [good manufacturing practice regulations] should be so identified publicly as soon as the agency is satisfied," the Michigan Democrat said. However, "this should not be interpreted as a request to expedite the inspection or evaluation process," Dingell cautioned. "At this stage in its history, it is far more important that the agency take all necessary measures to insure accuracy rather than speed in its review of the records of generic drug firms."

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