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FDA OFFICE OF LEGISLATIVE AFFAIRS WILL HAVE "INCREASED PRESENCE"

This article was originally published in The Tan Sheet

Executive Summary

FDA OFFICE OF LEGISLATIVE AFFAIRS WILL HAVE "INCREASED PRESENCE" over the coming months, incoming FDA Associate Commissioner for Legislative Affairs Diane Thompson forecasted at a Nov. 19 luncheon for members of Congress and staffers on FDA and women's health issues. Thompson, a former staffer to Sen. Barbara Mikulski (D-Md.), noted that her appointment is "part of, certainly, Commissioner [David] Kessler's commitment and [Deputy Commissioner for External Affairs] Carol Scheman's commitment to expanding and improving the role which the office of congressional affairs has played." Thompson is awaiting confirmation of the FDA appointment. FDA needs "you all to know and your bosses to know what the agency does and how we do it," Thompson told the staffers. "That makes you more informed consumers of the policy information that comes across your desks and your boss's desk and it enables you to both address the issues that are of concern to you but understand the constraints that the agency has to work with." The agency sees "this very much as a cooperative effort," she added. Thompson, Scheman and Special Assistant to the Commissioner for Women's Health Ruth Merkatz spoke at the meeting about FDA and women's health sponsored by the FDA Council, a Washington, D.C.- based, industry-sponsored advocacy group. Thompson pointed out that "all too often people think that the significance of having a women's perspective relates only to those things which can be categorized as women's issues." However, "that perspective is a much more universal and much more broad perspective," she stressed. An extensive package of women's health care legislation is currently before Congress. The Women's Health Equity Act of 1993 was introduced in the House in September by Congressional Caucus for Women's Issues co-chairs Patricia Schroeder (D-Colo.) and Olympia Snowe (R-Maine), and includes proposals to increase National Institutes of Health research on breast cancer, women and AIDS, ovarian cancer and lupus. Another provision in the women's health package would require drug companies to study interactions of new drugs with hormones prior to FDA approval.
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