Editorials, Opinion Pieces Respond To FDA's Announcement To Reconsider Plan B For Nonprescription Sales, Von Eschenbach Confirmation

Some editorials and opinion pieces respond to a July 31 letter to Barr Laboratories' subsidiary Duramed Research from FDA in which acting FDA commissioner Andrew von Eschenbach wrote that FDA is reconsidering the company's application to allow Barr's emergency contraceptive to be sold without a prescription to girls and women ages 16 and older. The letter says that 18 is the "appropriate age" to allow women to buy Plan B without a prescription and asks Barr to raise the age restriction in its application from 16 to 18. The letter also requests that Barr meet with FDA within seven days, make unspecified changes to the packaging for Plan B and provide a thorough description of the company's plan to enforce the age restriction. The editorials and opinion pieces also respond to von Eschenbach's confirmation hearings in the Senate Health, Education, Labor and Pensions Committee, which began one day after the letter was sent to Barr. During the hearing, committee members questioned him regarding the agency's review of the application (Kaiser Daily Women's Health Policy Report, 8/2). Summaries appear below.

Editorials

• Boston Herald: FDA "must act quickly to make sure there are no further delays in making [Plan B] more widely available to women who want to avoid an unwanted pregnancy -- not end one," a Herald editorial says. "This medication has the potential to eliminate millions of unwanted pregnancies -- and millions of abortions," the editorial adds, concluding, "[T]he time to act is now" (Boston Herald, 8/2).
  


• Denver Post: "We're encouraged to see progress" on Plan B's application for nonprescription sales, a "matter that could have been resolved a year ago," a Post editorial says. "Some senators see the FDA move as a political ploy to get von Eschenbach confirmed," the editorial says, adding, "We hope not" because the matter "should be resolved quickly and the plan implemented" (Denver Post, 8/1).
  


• Des Moines Register: The timing of von Eschenbach's letter is "reminder" that the Plan B controversy is "about politics" and not "about science," a Register editorial says. "It's time for science to prevail in a government agency that is supposed to be dedicated to keeping consumers safe based on medical facts -- not to making decisions based on politics" (Des Moines Register, 8/2).
  


• Long Island Newsday: "In a triumph of antiabortion ideology over science," FDA has "stalled attempts to make [Plan B] available without a prescription," which is an issue that "loomed" over von Eschenbach's confirmation hearings, a Newsday editorial says. FDA's letter implies that it might approve the application, which might allow von Eschenbach's confirmation -- which has been put on hold by Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) -- to continue, the editorial says (Long Island Newsday, 8/2).
  


• Oregonian: FDA's decision to consider Plan B for nonprescription sales does not "count as enlightenment" because the "change wouldn't help teenagers ... who are sexually assaulted or otherwise in distress," an Oregonian editorial says. The "compromise isn't ideal" because "teenagers under 18 would still need" prescriptions and "pharmacists still will be gatekeepers" to their EC access, according to the editorial. The decision "would simply move the agency a little closer to treating women and science with respect," the editorial says (Oregonian, 8/1).
  


• San Francisco Chronicle: Von Eschenbach at the hearing "said all the right things to lower the temperature" surrounding Barr's application, including that he hoped to come to a decision regarding the application "in a matter of weeks," a Chronicle editorial says. "Let's hope so," the editorial says, concluding, "It would be a good way to start his term as the nation's top drug regulator if he followed the scientific rule book and approved" nonprescription sales of Plan B (San Francisco Chronicle, 8/2).
  


• Seattle Times: The "social wars" over Plan B, which consist of FDA's "ideologically inspired foot-dragging" and the "alleged passive-aggressive 'out of stock' excuses of drug stores ... should stop," a Times editorial says. "FDA's handling of the Plan B application has been frustratingly ham-handed," the editorial says, adding, Plan B "should be readily available over the counter" (Seattle Times, 8/2).



• Washington Post: FDA might be "on the verge" of approving Barr's application or the agency's letter "could be just another FDA gambit, dangling the prospect of action in hopes of getting the acting commissioner confirmed," a Post editorial says, adding, "We hope it's the former." If emergency contraception were widely available, it could prevent up to 600,000 abortions and 1.5 million unintended pregnancies annually in the U.S., according to the editorial. "Plan A for the FDA should be making Plan B available" without a prescription, the editorial concludes (Washington Post, 8/3).

Opinion Pieces

• Maureen Downey, Atlanta Journal-Constitution: FDA has delayed approval of Barr's application for nearly three years, even though the agency's "experts have repeatedly deemed [Plan B] safe, effective and appropriate" for nonprescription sales, Downey, a member of the Journal-Constitution's editorial board, writes in an opinion piece. "Under the pretense of protecting young women from being victims of bad medicine," FDA has delayed a decision on the application "merely to appease extreme conservatives who want to preserve unwanted pregnancies as a just punishment for women who dare to have sex for any reason other than procreation," Downey says, concluding, "It's time that ended" (Downey, Atlanta Journal-Constitution, 8/2).
  


• Wendy Wright, Atlanta Journal-Constitution: "Easy access" to EC "would be harmful to women and girls," as countries that have approved nonprescription EC sales have seen "skyrocket[ing]" increases in sexually transmitted infections and "no drop in pregnancies and abortions," Concerned Women for America President Wright writes in a Journal-Constitution opinion piece. In addition, approval of Barr's application would allow adults to buy Plan B "and -- even in the store -- give it to a 13-year-old (without the parent's knowledge)," Wright says, adding that neither Barr nor FDA would have the ability to punish violators of the age restriction (Wright, Atlanta Journal-Constitution, 8/2).
  


• Cindy Richards, Chicago Sun-Times: The new restriction requirements expressed in von Eschenbach's letter could limit accessibility to Plan B in small towns and the increased age requirement "means a frightened teenager who just realized the condom broke would have to find a doctor to write a prescription," but "it's a start," Sun-Times columnist Richards writes in a Sun-Times opinion piece. She adds that Plan B's approval for nonprescription sales is "not a done deal" and that FDA could reconsider as it previously has done, but the hold on von Eschenbach's confirmation and the expected meeting between Barr and FDA imply that "things might be different this time" (Richards, Chicago Sun-Times, 8/2).

"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.