Morning-After Pill (Plan B): Over-the-Counter Use
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 "consumers”—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.” For Ms. McQuade’s full statement, see: www.usccb.org/comm/archives/2006/06-158.shtml.
For more background information, see the Secretariat for Pro-Life Activities’ web page at: www.usccb.org/prolife/issues/contraception/morningafterpill.shtml.
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)). For text, see: www.nyed.uscourts.gov/pub/rulings/cv/2005/05cv366mofinal.pdf.
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.” See: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149568.htm
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.” For the full statement see: www.usccb.org/comm/archives/2009/09-090.shtml. | |
