Sen. Patty Murray (D-Wash.) on Oct. 26 proposed an amendment to the Labor-HHS appropriations bill (HR 3010) that would have mandated an investigation into alleged mismanagement at FDA -- including the agency's handling of a proposal to make the emergency contraceptive Plan B available without a prescription -- but later withdrew the amendment because Sen. Tom Coburn (R-Okla.) would have introduced an amendment calling for an investigation into the agency's approval of mifepristone, FDA Week reports (FDA Week, 11/4). Murray's amendment would have shifted $3 million from the Office of the HHS Secretary to the agency's Office of Inspector General to conduct an investigation into alleged mismanagement at FDA, including its delayed decision on Barr Laboratories' application to make nonprescription Plan B available to women ages 17 and older (Murray release, 10/26). Former FDA Commissioner Lester Crawford in August announced that the agency would indefinitely defer the application and opened a 60-day public comment period on it, which expired on Nov. 1 (Kaiser Daily Women's Health Policy Report, 11/2). When Murray offered her amendment, Coburn, who opposes nonprescription access to Plan B, said he would offer a secondary amendment to fund an OIG investigation into FDA's 2000 approval of mifepristone, which is used to induce medical abortion (Mundy, Seattle Times, 11/7). FDA approved mifepristone under a set of FDA rules known as subpart H, which usually is reserved for approving drugs for life-threatening illnesses. A spokesperson for Coburn said that Murray then withdrew her amendment because both it and Coburn's secondary amendment immediately would have come to a vote. A spokesperson for Murray denied that assertion, saying that neither amendment would have reached a vote because they asked for new investigations, which should be introduced into legislation, not through an appropriations bill (FDA Week, 11/4).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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