Background: On August 24, 2006, the U.S. Food and Drug Administration (FDA) approved over-the-counter (OTC) distribution of the Plan B morning-after-pill (MAP) for Aconsumers”—men and women—18 years and older. The potent drug would remain available prescription-only for women 17 years and under. See: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108717.htm. The controversy over the approval goes back to 2003.
Plan B, a product of Duramed, a subsidiary of Barr Pharmaceuticals, is a levonorgestrel-only MAP that has not only contraceptive but also abortifacient properties. Deirdre McQuade, Director of Planning and Information for the Bishops’ Secretariat for Pro-Life Activities, objected to the OTC approval of Plan B. “Without the benefit of a doctor’s supervision, many women will be unaware of this abortifacient action and the other risks posed by Plan B.” Ms. McQuade urged health care providers “not to confuse FDA approval with a right to access and refuse to stock this potent drug for distribution on demand.”
Judicial: On March 23, 2009, U.S. District Judge Edward Korman, U.S. District Court of the Eastern District of New York, overturned the FDA’s August 24, 2006 determination that Plan B would be available OTC to men and women 18 years and older but would remain available prescription-only for women 17 years and under. The FDA was ordered “to permit Barr Pharmaceuticals, Inc. the Plan B drug sponsor, to make Plan B available to 17 year olds without a prescription, under the same conditions as Plan B is now available to women over the age of 18.” Tummino v. Torti, Memorandum and Order (No. 05-CV-366(ERK)(VVP)).
Executive: On April 22, 2009, FDA announced that “the government will not appeal this decision” and that it had notified the manufacturer of Plan B [Duramed Research, Inc. of Bala Cynwyd, PA] that it may “market Plan B without a prescription to women 17 years of age and older.” On April 22, the FDA announced that the administration would not appeal this decision.
Deirdre McQuade, Assistant Director for Policy and Communications at the Catholic bishops’ Secretariat of Pro-Life Activities, said that the FDA’s action “flies in the face of common sense.” Although Plan B can prevent fertilization, it may also prevent the conceived embryo from implanting in the womb. “Without the benefit of a doctor’s supervision, many teens will be unaware of this possible abortifacient action and the other risks posed by Levonorgestrel, particularly the risks from repeated use.”