FDA OFFICE OF LEGISLATIVE AFFAIRS WILL HAVE "INCREASED PRESENCE"

FDA OFFICE OF LEGISLATIVE AFFAIRS WILL HAVE "INCREASED PRESENCE" over the coming months, incoming FDA Associate Commissioner for Legislative Affairs Diane Thompson predicted at a Nov. 19 luncheon for members of Congress and staffers on FDA and women's health issues. Thompson, a former staffer to Sen. Mikulski (D-Md.), noted that her appointment is "part of, certainly, Commissioner 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 administrative 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" 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 industry group the FDA Council. 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 Schroeder (D-Colo.) and Snowe (R- Maine) ("The Pink Sheet" Sept. 20, T&G-14). The omnibus bill includes proposals to increase NIH research on breast cancer, women and AIDS, ovarian cancer and lupus. Another provision in the package would require drug companies to study interactions of new drugs with hormones prior to FDA approval. Scheman commented on FDA's position on off-label use. While the agency wants to allow for off-label use, for "people to have access to drugs," FDA would also like there to be an incentive for firms to submit additional efficacy data, Scheman said. She urged the staffers to consult with FDA when they begin addressing the portion of the Administration's health care reform proposal that is relevant to off-label use. The Administration's proposal "basically...provides for reimbursement for all approved drugs," Scheman said. However, there is a provision that would assure that FDA does not "completely lose the incentive [for companies] to come in for efficacy supplements," she added. The proposal gives authority to the HHS Secretary, that would be delegated to FDA, "to call for data, so that if a drug begins to be used very commonly," the agency can request additional data.