Morning-After Pill: Over-the-Counter Use

 

Executive: 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/bbs/topics/NEWS/2006/NEW01436.html. 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:

The USCCB’s opposition to OTC sales of Plan B is based on four primary reasons: (1) the abortifacient potential of Plan B (two of its four main actions could interfere with the survival of the early embryo); (2) problems for informed consent (OTC availability would reenforce the lack of awareness that Plan B can be an  abortifacient); (3) public health concerns (possible routine use of this potent drug, higher risk of ectopic pregnancy and sexually transmitted diseases); (4) the heightened prospect of coercing pharmacists to provide the drug against their conscientious objection. See the Bishops’ Secretariat for Pro-Life Activities’ web page at: www.usccb.org/prolife/issues/contraception/morningafterpill.htm.

On July 31, 2006, the U.S. Food and Drug Administration (FDA) had announced a framework for working with Duramed to resolve the remaining policy issues for the potential approval of OTC use of Plan B. The controversy over the approval goes back several years.

On April 16, 2003, Women’s Capital Corporation submitted to the FDA an application to allow the  MAP called Plan B to be sold OTC without a prescription. Later in 2003, Barr Pharmaceuticals acquired Plan B. On May 6, 2004, Steve Galson, Acting Director of the FDA’s Center for Drug Evaluation and Research, informed Barr that the OTC application was not approved. The FDA was especially concerned about the safe OTC use of Plan B by women less than 16 years of age. Barr subsequently submitted a modified proposal. In 2005, the FDA solicited public comments on some technical questions related to the modified proposal. Can the age criterion be used to decide if a drug should be prescription or over-the-counter? As a practical matter, how would the over-the-counter drug be regulated and enforced? If the drug is issued both ways (prescription and over-the-counter), can the drug be marketed in the same package? The 60-day comment period ended on November 1, 2005. In its July 31, 2006 letter to Duramed Research, the FDA said that it received approximately 47,000 comments.

Supporters of Plan B claimed that changing its status to OTC would decrease the number of abortions. A study coauthored by a Planned Parenthood doctor and published in the January 5, 2005 edition of the Journal of the American Medical Association cast serious doubt upon this contention. Commenting on the study’s findings, Cathy Cleaver Ruse, Esq., then Director of Planning and Information for the United States Conference of Catholic Bishops’ Secretariat for Pro-Life Activities, remarked: “Proponents have repeatedly claimed that making the drug available without a prescription would reduce abortion numbers by as many as half; now their own study debunks that claim.”

 See, Susan E. Wills, “Plan B: Politics vs. Science?” National Review Online (August 15, 2006) at: http://www.nationalreview.com/article/218486/plan-b-politics-vs-science-susan-e-wills?target=author&tid=901295

Ms. Wills argues that proponents of the widespread use of Plan B need to come to grips with the findings of science, namely, that studies show that the widespread use of “emergency contraception” (EC) like Plan B does not reduce rates of unintended pregnancy or abortion, that the repeated use of Plan B is not as safe as advertised, and that Plan B has at least four different modes of action, two of which are potentially abortifacient, depending on when sexual activity occurs and Plan B is taken in a woman’s fertility cycle.