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 December 16, 2003, two FDA advisory committees held hearings on this application and recommended that the Plan B pills be available over the counter. The recommendation was not binding.
On December 5, 2003, the U.S. Conference of Catholic Bishops had submitted a statement to the FDA in opposition to the Barr Research proposal.
On February 13, 2004, the FDA announced it would delay a decision for 90 days, stating it needed more time to review additional data.
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. “Based on a review of the data, we have concluded that you have not provided adequate data to support a conclusion that Plan B can be used safely by young adolescent women for emergency contraception without the professional supervision of a practitioner licensed by law to administer the drug.” 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 can resubmit either its original application or its amended March 11 proposal. It would be required to submit more data on safety and in the case of the March 11 proposal also include details on marketing Plan B for different age groups in a single packaging configuration. The FDA was especially concerned about the safe over-the-counter use of Plan B by women less than 16 years of age. Dr. Galson noted: “You propose OTC status for Plan B for both adults and children based primarily on an actual use study of 585 subjects. Only 29 of the 585 subjects enrolled in the study were 14-16 years of age, and none was under 14 years of age.”
Responding to the FDA’s May 6 decision, Cathy Cleaver Ruse, Director of Planning and Information for the USCCB’s Secretariat for Pro-Life Activities, stated, “We are pleased that the voice of reason prevailed . . . A drug which can destroy human embryos and increases health risks to women and girls does not belong on the drugstore shelf.” Plan B is an “overdose” of birth-control pills, which require a prescription. “It would be senseless to place a potentially dangerous ‘overdose’ of a prescription drug on the shelf next to the bandaids,” Ruse commented.
According to news stories, 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).
House: On July 13, 2004, during floor consideration of Fiscal Year 2005 Agriculture Appropriations Bill (H.R. 4766), Rep. Carolyn Maloney (D-NY) offered House Amendment 690 that denied funds “to restrict to prescription use a contraceptive that is determined to be safe and effective for use without the supervision of a practitioner licensed by law to administer prescription drugs. . . .” Rep. Chris Smith (R-NJ) said that this amendment only restated current law. He pointed out that the FDA denied approval to over-the-counter use of Plan B based on science and safety concerns. The Maloney amendment was agreed to without objection.
For a brief survey of the morning-after pill in public policy debates, see NCHLA briefing page at: nchla.org/docdisplay.asp?ID=64