Morning-After Pill: Over-the-Counter Use


Executive: On April 16, 2003, Barr Research laboratories submitted to the U.S. Food and Drug Administration (FDA) an application to allow the morning-after pill called Plan B to be sold over-the-counter (OTC) without a prescription. Plan B is a levonorgestrel-only pill that has both contraceptive and abortifacient properties. On May 6, 2004, Steve Galson, Acting Director of the FDA’s Center for Drug Evaluation and Research, informed Barr Research laboratories that its application was not approved. The FDA was especially concerned about the safe over-the-counter use of Plan B by women less than 16 years of age. On March 11, 2004, Barr Research had amended its proposal to allow over-the-counter distribution of Plan B only to women 16 years and older. The FDA considered this amendment incomplete. Barr Research laboratories subsequently submitted a modified proposal, allowing over-the-counter sale of Plan B only to women 16 and older (Washington Post, June 23, 2004, A6).

The FDA solicited public comments on some narrow technical questions related to the Barr 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. 

For statements by the FDA, see:

In an October 27, 2005 letter to the FDA, Mark Chopko, USCCB General Counsel, opposed permitting OTC sale of the Plan B pill to minors. Plan B “is one instance of a drug in which over-the-counter availability, either generally or to a subpopulation, would be injurious to many – children and adults, as well as health care providers and professionals.” 

Supporters of Plan B claim that changing its status to OTC would decrease the number of abortions. A recent study coauthored by a Planned Parenthood doctor and published in the January 5, 2005 edition of the Journal of the American Medical Association casts serious doubt upon this contention. Commenting on the study’s findings, Cathy Cleaver Ruse, Esq., 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.”