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Opinion | Kaiser Daily Reproductive Health Report Summarizes Editorials on FDA's Delayed Decision on Plan B

[Sep 02, 2005]

FDA Commissioner Lester Crawford last week said the agency is indefinitely deferring 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 decision was motivated by politics rather than science. FDA in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B -- which can prevent pregnancy if taken within 72 hours of sexual intercourse -- 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. 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. As a result of the agency's action, FDA Assistant Commissioner for Women's Health Susan Wood on Wednesday 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" (Kaiser Daily Reproductive Health Report, 9/1). Several newspapers have published editorials in response to FDA's delayed decision on Plan B. Some of these are summarized below.

Atlanta Journal-Constitution: FDA should "do its job and stop being held hostage to antiabortion activists and politicians who would rather condemn women for having abortions than help them prevent pregnancies," a Journal-Constitution editorial says. Although several states have moved to make EC more widely available through nurses and pharmacists, "a patchwork quilt of state regulations is not what the country needs," the editorial says (Atlanta Journal-Constitution, 8/31).
Austin American-Statesman: Leavitt's "promise to act has been broken," a Statesman editorial says, concluding that FDA's "course is clear: Set an age limit, approve the drug for over-the-counter sales and stop interfering in the personal lives of American women" (Austin American-Statesman, 8/31).
Boston Globe: FDA "bowed once again to political pressures" by delaying its decision on Plan B, a Globe editorial says, adding that "the best way to make Plan B more available to reduce abortion in this country would be for the FDA to approve over-the-counter sales without age restrictions" (Boston Globe, 8/31).
Chicago Sun-Times: FDA "wimped out" when it came "to making bold decisions on behalf of women," a Sun-Times editorial says. "Allowing greater access to Plan B could prevent" some of the three million unplanned pregnancies and the number of abortions that occur annually in the U.S., the editorial says, concluding, "It's surprising the opponents of Plan B haven't figured that out yet. Or the faint-hearted old FDA" (Chicago Sun-Times, 9/1).
Chicago Tribune: FDA has created "roadblock after roadblock" to prevent nonprescription sales of EC, but with "each delay, it gets harder to accept" the agency's reasoning, a Tribune editorial says. The editorial calls on Illinois to "act on its own" if FDA is "going to continue dragging its feet" and allow EC to be sold without a prescription in the state (Chicago Tribune, 9/2).
Eugene Register-Guard: FDA "must be ferociously embarrassed at having to concoct yet another lame excuse" for delaying its decision on Plan B, a Register-Guard editorial says. The editorial calls on Crawford to "[s]top stalling," adding, "You've got thousands upon thousands of public comments already. Approve Plan B now" (Eugene Register-Guard, 8/29).
Long Island Newsday: "Drugs and politics don't mix," a Newsday editorial says, adding, "Taken together they're threatening [FDA's] credibility as an agency that dispassionately evaluates the safety and effectiveness of drugs." The editorial concludes, "A yes or no decision by the FDA isn't too much to ask and, given the evidence, that decision should be yes" (Long Island Newsday, 8/31).
Miami Herald: "If it will assuage the FDA's queasiness, why not" require women to show ID to receive Plan B contraception, a Herald editorial says, adding, "While this could cause some discomfort, especially for women living in small towns, it's a small price to pay to get this drug out of FDA's clutches and into the mainstream" (Miami Herald, 8/31).
Philadelphia Daily News: "How long will the federal government get away with basing decisions on politics, not scientific evidence?" a Daily News editorial asks, noting that the "most recent was the delay, yet again, of approval" for nonprescription sales of Plan B. The editorial answers its question, "Government will play political games with our health until we demand that it stop" (Philadelphia Daily News, 9/2).
Pittsburgh Post-Gazette: Crawford's "excuses for stringing out" the process of approving Plan B for nonprescription sales sound "lame and reek of political meddling," a Post-Gazette editorial says, adding that FDA's "Plan A should be to confront concerns that politics trumps science in its executive suite and stop stalling on Plan B" (Pittsburgh Post-Gazette, 9/1).
St. Petersburg Times: FDA has announced "what amounts to a Plan C for the morning-after pill marketed as Plan B: Stall," a Times editorial says. "Maybe President Bush wants to punt this ball down the field for the next president, but he will be hard-pressed to answer for a commitment" made by Leavitt to the Senate in July, the editorial says (St. Petersburg Times, 8/31).
Seattle Post-Intelligencer: "We're so impressed" by Wood's resignation, but "we also feel that she's just the sort of person -- a scientist with integrity -- who ought to stay in the fight" to approve nonprescription sales of Plan B, a Post-Intelligencer editorial says. "Heck, why allow a safe form of emergency birth control now when they could do it on the 12th of Neveruary?" the editorial asks, adding, "It's not like this country leads the world in the number of unplanned pregnancies. Oh wait, yes it does -- three million, every year" (Seattle Post-Intelligencer, 9/2).
Springfield Republican: FDA's postponement of a decision on Plan B contraceptive sales "should have been announced on Groundhog Day" -- instead of on Friday, Women's Equality Day -- "because the FDA is apparently afraid of its own shadow," a Republican editorial says. Members of Congress should "deman[d] that the FDA disregard ideological beliefs when making its decisions; in this case, a decision that will give women the power to safely and effectively protect themselves," the editorial says (Springfield Republican, 8/31).
Virginian-Pilot: A "more reasonable" view of Plan B is that it can prevent "tens of thousands of abortions and unwanted pregnancies," a Virginian-Pilot editorial says, noting that restricting access to minors "is consistent with other national reproductive policies and therefore valid." The editorial concludes, "A country that can put a man on the moon can surely figure out how to distinguish between younger and older women in selling a pill. If, that is, policymakers care half as much about science in one case as in the other" (Virginian-Pilot, 8/31).

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=32377

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