Summary of editorials on approval of nonprescription plan B sales to women over age 18

Aug 30 2006

Some editorials respond to FDA's decision on Thursday to approve Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B to women ages 18 and older.

The approval came after the agency in May 2004 issued a "not approvable" letter in response to an application originally submitted by the pharmaceutical company Women's Capital for nonprescription sales of Plan B, which can prevent pregnancy if taken up to 72 hours after sexual intercourse.

Barr purchased Women's Capital during consideration of the application. FDA in the "not approvable" letter cited inadequate data on Plan B's use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available without a prescription only to girls and women ages 16 and older.

In a July 31 letter to Barr subsidiary Duramed Research, acting FDA Commissioner Andrew von Eschenbach wrote that 18 is the "appropriate age" to allow women to buy Plan B without a prescription and asked Barr to raise the age restriction in its application from 16 to 18. Barr earlier this month resubmitted its application.

The approval requires Barr to "[m]onitor the effectiveness of the age restriction and the safe distribution of [nonprescription] Plan B to consumers [ages] 18 and above and prescription Plan B to women under [age] 18."

Barr has agreed to send "anonymous shoppers" into pharmacies to test compliance with the age restriction, to distribute with the drug a booklet about its proper use, and to exclude gas stations and convenience stores from selling the drug.

Barr spokesperson Carol Cox said Plan B should be available for nonprescription sales this fall (Kaiser Daily Women's Health Policy Report, 8/25).

• Arizona Daily Star: Although FDA's decision on Plan B "came as a welcome surprise," it is "only a partial solution that leaves young women without equal access to health care," a Daily Star editorial says. "So while the FDA made a good, albeit incomplete, decision on Plan B, it is vital to remember that the battle for reproductive rights continues," the editorial says, concluding, "Young women deserve equal access to health care" (Arizona Daily Star, 8/29).
  
  
• Austin American-Statesman: The Plan B application "shouldn't have been delayed ... because of political considerations," an American-Statesman editorial says, adding that FDA "finally did the right thing by approving" nonprescription sales of Plan B to women ages 18 and older (Austin American-Statesman, 8/30).
  
  
• Chicago Sun-Times: "Congratulations to [FDA] for finally recognizing women are adults who can make their own reproductive" decisions, a Sun-Times editorial says. Plan B "became a political hot potato," but FDA's approval process "should not be mired in politics; it should be a safety and health issue," the editorial says. "Thank goodness sanity has finally prevailed," the editorial concludes (Chicago Sun-Times, 8/29).
  
  
• Dallas Morning News: It is a "good thing that, after three years of foot-dragging," FDA has "finally stopped the politicking" and approved nonprescription sales of Plan B for women ages 18 and older, a Morning News editorial says. "In the short term, approval of Plan B may help restore some credibility to the troubled agency," the editorial says, concluding, "We'd all feel safer if the agency stuck to its job description of regulating and verifying the effectiveness of drugs and left sanctioning morality to individuals and politics in Washington" (Dallas Morning News, 8/26).
  
  
• Las Vegas Sun: It is "clear" that the Bush administration "bullied the FDA into dragging its feet" on its approval of Plan B for nonprescription sales to women ages 18 and older, a Sun editorial says. "It is frustrating, but not surprising, that Bush administration politics taints the scientific processes on which federal agencies base important decisions regarding Americans' health," the editorial says, concluding, "The Bush administration seems unable to separate important scientific considerations from the administration's political ones" (Las Vegas Sun, 8/28).
  
  
• Long Island Newsday: Approving Barr's application "was the right thing to do," but the "specter of ideology and political calculation" surrounding the lengthy approval process was "inescapable," a Newsday editorial says. The safety and efficacy of Plan B have been the "same throughout the ... three years" FDA delayed approval of nonprescription sales of the drug, but "[w]hat changed was the intensity of political heat on officials to make a decision," the editorial concludes (Long Island Newsday, 8/29).
  
  
• Oregonian: By "settling on a political compromise that pretends that Plan B is somehow still dangerous for 16- and 17-year-olds," FDA has "deliberately chosen to keep the drug out of reach of the very girls who are the youngest and least prepared for motherhood, or an abortion," an Oregonian editorial says. "Maybe that arbitrary distinction makes some kind of strange sense in terms of abortion politics," the editorial says, concluding, "But in terms of women's health, it makes none at all" (Oregonian, 8/25).
  
  
• Raleigh News & Observer: "Based on need as well as science, [FDA] was right to give Barr ... a green light" concerning their application to allow nonprescription sales of Plan B to women ages 18 and older, a News & Observer editorial says. "FDA sets useful parameters, relying on Barr to ensure that pharmacies take seriously their duty to follow the rules on Plan B," the editorial says, adding that "parents of resourceful teenagers must realize it's not a fool-proof system." The editorial concludes, "Young teenagers need the guidance of their parents, which often is the most effective contraceptive around" (Raleigh News & Observer, 8/28).
  
  
• Seattle Times: FDA's approval of Plan B to women ages 18 and over "represents progress, but the conditions still have the potential to limit on-demand access because the drug can be purchased only at a pharmacy when the pharmacist is on duty," a Times editorial says. "[B]y keeping the drug behind the counter, the restriction could run up against the proclivities of a few pharmacists who want to meddle in the contraceptive choices of women," the editorial adds (Seattle Times, 8/28).
  
  
• Springfield Republican: FDA's approval of Barr's application for nonprescription sales of Plan B to women ages 18 and older will "help restore faith" in the agency, but "alone won't restore the FDA's credibility," a Republican editorial says. But in future decisions, there should be "[n]o more politics" because the "side effects proved awful," the editorial adds (Springfield Republican, 8/25).
  
  
• St. Petersburg Times: FDA has "no excuse" for taking three years to approve Plan B for nonprescription sales to women ages 18 and older, a Times editorials says, adding that it was because of the "Bush administration's appeasement" of people who oppose abortion rights that the approval Barr's application was delayed. "We are glad to see the agency finally came to its senses," the editorial concludes (St. Petersburg Times, 8/29).