FDA Commissioner Lester Crawford on Friday 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 make a decision on Barr's application by Sept. 1 (Kaiser Daily Reproductive Health Report, 8/29). Several newspapers have published editorials and opinion pieces and some groups have issued press releases in response to FDA's delayed decision on Plan B. Some of these are summarized below.

Editorials

• Detroit Free Press: FDA's indefinite delay in approving Barr's application for Plan B "is worse than disappointing, ... it's disingenuous," a Free Press editorial says. FDA "should make these pills readily available," the editorial says, concluding that if FDA "is going to insist on the artificial age limit, the agency should figure out how to enforce it, not use it as an excuse to delay again what should have been done long ago" (Detroit Free Press, 8/27).
  
  
• Honolulu Star-Bulletin: The Bush administration "continues to throw monkey wrenches into the approval process and hatch bogus issues as pretext to delay nonprescription sales of what its own medical experts have said is a safe and effective drug," a Star-Bulletin editorial says, concluding that the FDA's "postponement is unjustifiable" (Honolulu Star-Bulletin, 8/29).
  
  
• New York Times: FDA's reason for delaying a decision on Plan B is "lame" because if "profound" policy issues have been raised, "the agency has had plenty of time to grapple with them," a Times editorial says (New York Times, 8/30).
  
  
• Oregonian: FDA "appears to be responding less to scientific evidence than to conservative constituencies" in delaying a decision on Plan B, an Oregonian editorial says. The agency "should skip the politics and do its job," the editorial says, concluding, "In all matters relating to pregnancy prevention, delay is not the answer" (Oregonian, 8/29).
  
  
• Philadelphia Daily News: FDA has acknowledged that Plan B is safe "without a prescription -- even for teens -- but apparently it is bending to the will of conservatives who fear that this newest contraception will -- as usual -- encourage teens to have sex," a Daily News editorial says. According to the editorial, "you can't argue that FDA is approving an over-the-counter abortion" by allowing nonprescription sales of EC, adding, "But that's the rhetoric coming out of the right, which apparently would rather pretend teens are not having sex and experiencing unwanted pregnancies than deal with the issue" (Philadelphia Daily News, 8/29).
  
  
• San Francisco Chronicle: An advisory panel of scientists "urged approval" of Plan B, saying it "isn't harmful and should be available," which is "sensible advice, not dilatory politics, that the FDA should heed," a Chronicle editorial says (San Francisco Chronicle, 8/30).
  
  
• Seattle Post-Intelligencer: "If there's a conflict between science and political pandering, Bush officials are happy to ignore the facts, flout the law and place their faith in bringing out far-right voters," a Post-Intelligencer editorial says. FDA and Bush administration officials repeatedly have broken promises to act on Barr's application, creating a "pattern: Do what Karl Rove orders," the editorial concludes (Seattle Post-Intelligencer, 8/30).
  
  
• USA Today: FDA's decision is a "blatant cave-in to political pressure from opponents of abortion rights at the expense of its own standards," a USA Today editorial says. "By letting political considerations trump scientific fact, the FDA undermines its credibility," the editorial says, adding, "More immediately, it leaves too many high school girls ... and 800,000 others nationwide each year having to decide whether to have an abortion, put a baby up for adoption or raise a child before they are capable" (USA Today, 8/29).
  
  
• Washington Post: Crawford's announcement that FDA needs more time to consider Barr's application puts "the agency at risk of losing its credibility," a Post editorial says. "Whatever the legal arguments taking place, this unexpected delay at this stage of the approval process makes the FDA -- long admired around the world for its neutrality and professionalism -- look like an easily manipulated political tool," the editorial concludes (Washington Post, 8/30).
  

Opinion Pieces

• Marie Cocco, Long Island Newsday: "The official objections to emergency contraception aren't about medicine or even marketing," they are "about politics," columnist Cocco writes in a Newsday opinion piece. The "right wing" has "begun employing the same tactics against safe, legal birth control that it has used in its war against safe, legal abortion" by creating "diversions and distortions to confuse public debate and make people believe there must be something amiss," Cocco says (Cocco, Long Island Newsday, 8/30).
  
  
• Jenice Armstrong, Philadelphia Daily News: Conservatives fear an "unleashing of the sexual floodgates" if restrictions on Plan B are loosened, but making the drug available without a prescription will not spark a "nationwide, free-wheeling sex party" as opponents of the drug "would have you think," columnist Armstrong writes in a Daily News opinion piece (Armstrong, Philadelphia Daily News, 8/30).
  
  
• Paul Caprio, USA Today: FDA "acted in the best health and safety interests of American women" by delaying Barr's application, Caprio, director of the Chicago-based family advocacy group Family-Pac Federal, writes in a USA Today opinion piece. Approval of Plan B "would turn medical supervision of women's contraceptives upside-down" by making pharmacists "bartenders trying to determine a woman's age and identification," Caprio says. "[I]t is time for the FDA to exercise common-sense caution and reject this ill-conceived plan to allow pharmaceutical profits and special interest politics to trump serious health concerns for women," he concludes (Caprio, USA Today, 8/29).
  

Press Releases

• Nancy Northup, Center for Reproductive Rights: "Here we are days before the Supreme Court confirmation hearings -- a possible turning point in reproductive privacy and decision-making -- and this administration has once again willfully chosen to place a choke-hold on women's access to sensible and safe reproductive health care," CRR President Northup said, adding, "It is unconscionable that the FDA has resorted to yet another stalling tactic to avoid making Plan B available without a prescription" (CRR release, 8/26).
  
  
• Wendy Wright, Concerned Women for America: "Making the morning-after pill over-the-counter would only benefit those that profit from its increased sales, but the real price will be paid by women and girls who would suffer the health consequences," CWA Senior Policy Director Wright said (CWA release, 8/26).
  
  
• JoAnn Smith, Family Planning Advocates of New York State: "This is extremely frustrating for women," FPA President and CEO Smith said, adding, "Every day the FDA fails to increase access to EC means more unintended pregnancy and more abortion" (FPA release, 8/26).
  
  
• Eleanor Smeal, Feminist Majority Foundation: "These stall tactics are only harming women and increasing the need for abortions," FMF President Smeal said, adding that the Bush administration "continues to slam the door in the face of women's progress" (FMF release, 8/26).
  
  
• Nancy Keenan, NARAL Pro-Choice America: "FDA's delay flies in the face of an American majority that believes more should be done to reduce unintended pregnancies and the need for abortion," NARAL Pro-Choice America President Keenan said, adding, "Scientists, doctors and Americans across the political spectrum support giving women, especially survivors of sexual assault, better access to the morning-after pill to prevent unintended pregnancies" (NARAL Pro-Choice America release, 8/26).
  
  
• Kim Gandy, National Organization for Women: "This is just another in a long line of decisions that make women's health secondary to right-wing politics," NOW President Gandy said, adding, "This administration is determined to turn the FDA into an arm of the Republican Party -- carrying out the fondest desires of Bush allies who oppose women's use of contraception" (NOW release, 8/26).
  
  
• Marcia Greenberger, National Women's Law Center: "Despite conclusive scientific evidence that emergency contraception is safe for over-the-counter use, the FDA without persuasive justification has once again deferred a decision on expanding access to this time-sensitive, pregnancy-preventing drug," NWLC Co-President Greenberger said, adding, "The availability of emergency contraception should not be a political issue when women's health is on the line" (NWLC release, 8/26).
  
  
• George Thomas, Physicians for Reproductive Choice and Health: "It's unprecedented to have so many delays when the scientific evidence is so clear. This appears to be yet another stall tactic that puts politics ahead of science," PRCH board member Thomas said, adding, "Giving women timely access to emergency contraception is a public health imperative, and these delays are unconscionable" (PRCH release, 8/26).
  
  
• Karen Pearl, Planned Parenthood Federation of America: "It is a terrible day for women's health and safety. It is crystal clear that the FDA has chosen politics over legitimate science," PPFA Interim President Pearl said, adding that FDA "has failed its public health responsibilities and has failed women" (PPFA release, 8/26).
  
  
• Kirsten Moore, Reproductive Health Technologies Project: FDA "once again turned its back on American women by failing to approve back-up birth control for use without a prescription" and "sidestepped its obligation to act on the scientific evidence and promote public health," RHTP President Moore said (RHTP release, 8/26).