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Kaiser Daily Reproductive Health Report Summarizes Opinions on FDA's Delayed Decision on Plan B

FDA Commissioner Lester Crawford last month said the agency is indefinitely deferring a decision on... Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B and opening a 60-day public comment period on the application, sparking charges that the action was motivated by politics rather than science. As a result of the agency's action, FDA Assistant Commissioner for Women's Health Susan Wood last week resigned from her position, saying, "I can no longer serve ... when scientific and clinical evidence, fully evaluated and recommended for approval by professional staff here, has been overruled." FDA in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription and in January delayed a ruling on Barr's revised application, which would allow EC to be sold without a doctor's prescription only to women ages 17 and older (Kaiser Daily Reproductive Health Report, 9/1). In July, HHS Secretary Mike Leavitt in a letter to Sen. Mike Enzi (R-Wyo.), who chairs the Senate Committee on Health, Education, Labor and Pensions, said that FDA would act on Barr's application by Sept. 1, later adding that the agency never guaranteed a "yes or no" decision (Kaiser Daily Reproductive Health Report, 8/30). Several newspapers have published editorials and opinion pieces in response to FDA's action. Some of these are summarized below. Editorials
Baltimore Sun: It is "clearly no coincidence that Dr. Crawford's abundance of caution is being applied to" the issue of nonprescription sales of Plan B, a Sun editorial says. Crawford has been "forced to adopt many improbable positions in order to keep his job," the editorial says, adding, "But now he's at risk of turning the world's most respected drug-reviewing agency into a laughingstock" (Baltimore Sun, 9/6).

Bergen Record: FDA's Plan B "debacle" shows, among other things, that some leaders of the antiabortion movement "don't seem to care as much about reducing abortions as they do about dictating morality," a Record editorial says. Last week, the American Academy of Pediatrics endorsed nonprescription sales of Plan B; however, Crawford "hasn't been listening to the doctors, ... [o]nly to the zealots," the editorial says (Bergen Record, 9/7).

Des Moines Register: "If there's ever been a subject pro-lifers and pro-choicers should agree on, it's the morning-after pill," a Register editorial says, adding, "[FDA] should spend more time trying to prevent deaths from drugs like Vioxx than worrying about whether a teen is purchasing a safe and smart product" (Des Moines Register, 9/9).

Houston Chronicle: "Rather than demonstrating a commitment to women's health, the FDA pulled a fast one" by deferring a decision on Barr's application for Plan B, a Chronicle editorial says. "It should be plain by now that the administration ranks protecting the health of American women and basing decisions on science somewhere below currying favor with its political base," the editorial concludes (Houston Chronicle, 9/5).

Los Angeles Times: The real issue with EC is that there is a "minority opinion among those who oppose abortion that morning-after contraception is itself abortion," a Times editorial says, concluding, "[T]his minority holds disproportionate sway in the Bush administration ... [a]nd that's why Crawford, absurdly calling for more study, reneged ... on a promise to deliver a decision" on Plan B by Sept. 1 (Los Angeles Times, 9/6).

Portland Press Herald/Maine Sunday Telegram: Wood's resignation might "force some needed clarity on the issue of" nonprescription sales of EC, a Press Herald/Sunday Telegram editorial says. Legislators are now calling for congressional hearings to investigate why "FDA is not recognizing the scientific findings of its staff, thus thwarting advance of the emergency contraception," the editorial says (Portland Press Herald/Maine Sunday Telegram, 9/6).

South Florida Sun-Sentinel: FDA "doesn't need a new rule or the years-long delay" in approving EC; "it needs a backbone," a Sun-Sentinel editorial says. The agency "must be reminded that its role requires science be its guide, not moral and political pressures," the editorial says, adding that FDA "should stop playing politics and do the job required of it" (South Florida Sun-Sentinel, 9/8).

St. Louis Post-Dispatch: The Bush administration has "consistently filtered science through a distorted political lens," a Post-Dispatch editorial says. "Now in the name of ending abortion, it is denying women access to a safe, effective method for preventing pregnancy -- even if that results in more abortions," the editorial adds, concluding, "That might be good politics, but it is inhumane and reckless public policy" (St. Louis Post-Dispatch, 9/5). Opinion Pieces
Susan Reimer, Baltimore Sun: FDA's action is the "latest in a series of insidious assaults" on the reproductive health of women by the Bush administration, columnist Reimer writes in a Sun opinion piece. "If the Bush administration and the arch-conservatives who support his family-life agenda were to have their way, 'The 40-Year-Old Virgin' would not be a silly summer movie. It would be government policy," Reimer concludes (Reimer, Baltimore Sun, 9/6).

Jim Spencer, Denver Post: FDA "bowed to antiabortionists and prudes" by delaying the decision on Barr's application, columnist Spencer writes in a Post opinion piece, adding that the decision had "nothing to do with science." The agency's reasoning for continued delays are "a smoke screen" and a "betrayal" to U.S. women, Spencer says (Spencer, Denver Post, 8/31).

Alastair Wood et al., New England Journal of Medicine: A drug's efficacy and safety "are the only legitimate considerations for FDA approval," and an agency advisory committee in December 2003 agreed that Plan B meets both considerations, Wood, a professor of medicine and pharmacology at Vanderbilt University School of Medicine, NEJM Editor in Chief Jeffery Drazen and NEJM associate editor Michael Greene write in a NEJM opinion piece. "The recent actions of the FDA leadership have made a mockery of the process of evaluating scientific evidence, disillusioned many of the participating scientists both inside and outside the agency, squandered public trust and tarnished the agency's image," the authors say, adding, "American women and the dedicated professionals at the FDA deserve better" (Wood et al., New England Journal of Medicine, 9/22).

Kiera Camron, Tallahassee Democrat: "I, for one, am thankful for the FDA taking the time to look more carefully" at Barr's emergency contraceptive Plan B, Kiera Camron, former executive director of Open Door Women's Clinic in Tallahassee, Fla., writes in an opinion piece. It is FDA's "responsibility to ensure the involvement of medical professionals and prevent the over-the-counter sale of EC," adding, "With any luck, [the agency] will conclude that over-the-counter EC is one 'blessing' America can do without," she says (Camron, Tallahassee Democrat, 9/9).


NPR's "Talk of the Nation/Science Friday" in the first hour of the program is scheduled to include a discussion of FDA's action on Plan B. Guests on the program are scheduled to include David Hager, former member of the FDA Reproductive Health Drugs Advisory Committee and a professor in the Division of General Obstetrics and Gynecology at the University of Kentucky College of Medicine; Vivian Lewis, director of the Division of Reproductive Endocrinology at the University of Rochester Medical Center; and Alastair Wood, professor of medicine and pharmacology at Vanderbilt University School of Medicine (Flatow, "Talk of the Nation/Science Friday," NPR, 9/9). The complete segment will be available online after the broadcast at 6 p.m. ET.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

View drug information on Vioxx.





Kaiser Daily Sãnãtatea reproducerii Raport rezumã Opiniile pe FDA a Întârziat Decizie privind Planul B - Kaiser Daily Reproductive Health Report Summarizes Opinions on FDA's Delayed Decision on Plan B - articole medicale engleza - startsanatate