Kaiser Daily Women's Health Policy Report Summarizes Editorials On Nonprescription Sales Of Plan B

Chicago Tribune and Wall Street Journal editorials respond to a July 31 letter to Barr Laboratories' subsidiary Duramed Research from FDA in which acting FDA Commissioner Andrew von Eschenbach wrote that the agency 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. FDA spokesperson Susan Bro said that Barr and FDA are scheduled to meet on Tuesday in Washington, D.C., to discuss the application (Kaiser Daily Women's Health Policy Report, 8/3). The editorials 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.

• Chicago Tribune: If von Eschenbach is committed to "maintaining the long-standing traditions and values" of FDA and to being guided by "sound science," then "his first order of business should be to end this shameful chapter in FDA history and grant the approval" of Plan B for nonprescription sales, a Tribune editorial says, adding, "The evidence is overwhelming that the [medication] is safe and effective," and past decisions have been based on "[p]olitics, not science." Despite the letter, approval of the application is "not assured" and because of FDA's history regarding Plan B's application, "some skepticism is warranted" when looking at its recent announcement, according to the Tribune. The editorial concludes, "Unfortunately, politics may yet trump science again" (Chicago Tribune, 8/4).
  


• Wall Street Journal: Even though FDA "regulates many lifesaving and life-improving products," questioning at von Eschenbach's confirmation hearing on Tuesday "focused almost entirely" on Barr's application for nonprescription sales of Plan B, a Journal editorial says. The editorial adds that Plan B is "only one of thousands of drugs FDA regulates," many of which are "promising new therapies ... that will continue to suffer needless delays unless the FDA gets a confirmed commissioner with political clout." If senators, such as Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.), continue to discuss "minor issues" instead of confirming von Eschenbach, HELP Committee Chair Mike Enzi (R-Wyo.) should "cal[l] them on the deadly serious consequences of their political quibbling," the editorial concludes (Wall Street Journal, 8/4).

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