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, former FDA Assistant Commissioner for Women's Health Susan Wood last month 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. 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, 9/1). Several newspapers have published editorials and opinion pieces in response to FDA's action. Some of these are summarized below.

Editorials
Dayton Daily News: FDA's decision to delay Plan B is not about a concern for women's health but rather "the degree that some people think they're entitled to go to control the kind of birth control others use," a Daily News editorial says. "Critics don't have the power to outlaw [EC] altogether, so they're doing what they can -- at a politicized FDA -- to complicate a woman's life when that woman is desperately looking for a way to prevent a pregnancy or maybe even an abortion," according to the editorial (Dayton Daily News, 9/19).

Newport News Daily Press: The concerns about whether 16-year-olds will be able to understand the drug's labeling "should be seen for what it is: pandering to the religious right," a Daily Press editorial says, adding that age restrictions for sales of alcohol and cigarettes have been in place for decades. "By capitulating to religious zealots who oppose not only abortion, but birth control, the Bush administration is preventing millions of women from one of the most effective ways to curb abortion," according to the editorial (Newport News Daily Press, 9/18).

Peoria Journal Star: Given that two scientific advisory panels and FDA staff members have said that Plan B is safe for nonprescription sales, either the agency's "doctors and administrators are not as smart as most of us count on them to be" or "science is not driving the decision, religious belief is," a Journal Star editorial says. FDA should "stand by the science that says Plan B can be sold safely on drug store shelves," the editorial concludes (Peoria Journal Star, 9/13).

Philadelphia Inquirer: FDA's "dithering is more evidence" that the Bush administration is "aligned with the right against birth control," an Inquirer editorial says. Congress should call Crawford "on the carpet" and pass the Access to Legal Pharmaceuticals Act, which would "ensure that patients can obtain from their drugstore the medicine prescribed by their doctors, including birth control," the editorial concludes (Philadelphia Inquirer, 9/13).

Providence Journal: Arguments against making Plan B available for nonprescription sales are not "enough to offset the broad public health benefits of making emergency contraception readily available," a Journal editorial says, adding, "Nor are they sufficient grounds to deprive women of what should be a personal decision." FDA has "thrown an unconscionable barrier in the way of Americans who would practice responsible birth control," the editorial says, concluding, "Its stalling must cease" (Providence Journal, 9/12).

Tacoma News Tribune: The debate over Plan B is not a "debate about science" but is about a "religiously minded minority that wants to lump Plan B into the abortion debate," a News Tribune editorial says. FDA is "proving that when push comes to shove, Americans cannot trust the agency to let science be its guide," the editorial concludes (Tacoma News Tribune, 9/14).

Opinion Pieces
Ellen Goodman, Boston Globe: FDA has "given politics a veto over science" by casting the debate over Plan B as a "teenage protection plan" and denying contraception to women of all ages, columnist Goodman writes in a Globe opinion piece. If teenagers "need Plan B, it's because Plan A -- abstinence -- fails more often than condoms," Goodman writes, concluding that too many teenage girls become pregnant and face "Plan C: abortion or motherhood" (Goodman, Boston Globe, 9/16).

Jo Tolck, Minneapolis Star Tribune: Barr's desire to sell nonprescription Plan B is "just a moneymaking scheme that picks all of our pockets and in many cases fills no particular medical need," Tolck, executive director of the Human Life Alliance, writes in a Tribune opinion piece. The Planned Parenthood Federation of America would make at least $100 million in profits over the next five years if Plan B were approved, and Barr likely would sell the drug to pharmacies for at least double the amount it sells the contraceptive to PPFA, Tolck writes, adding that the "general public gets to pick up the inflated tab." FDA should "quickly realize the financial motivation behind the push for approval" and "summarily deny the request," Tolck concludes (Tolck, Minneapolis Star Tribune, 9/17).

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