Administration Stops Plan B Expansion

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Administration Stops Plan B Expansion

Special Report - December 9, 2011
U.S. Department of Health and Human Services Secretary Kathleen Sebelius has stepped in to prevent the Food and Drug Administration (FDA) from making the “morning-after” abortifacient drug, Plan B One-Step, available over the counter without a prescription and without an age requirement. Sebelius issued a memorandum and press release on December 7, nixing the FDA’s plan to allow Plan B to be available to all women without a prescription, regardless of age. She cited her authority to do so under the Federal Food, Drug, and Cosmetic Act, based on her “conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional.”

Sebelius expressed concern in her memorandum “that the ‘label comprehension and actual use studies submitted to FDA do not include data on all ages for which the drug would be approved and available over-the-counter.’” She went on to point out that “it is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age.” According to Sebelius, this would include girls as young as 11 years.

Since April 2009, Plan B has been available without a prescription to women 17 years and older. Women younger than 17 can purchase Plan B with a prescription. This decision by Sebelius does not affect current availability. The FDA’s plan to make Plan B available over-the-counter came after a February 2011 request from Teva Pharmaceutical Industries, which manufactures Plan B, to allow Plan B to be “available over the counter for all girls of reproductive age.”

Related resources:
FDA to Allow More Access to Contraceptives  - April 29, 2009
FDA Approves Nonprescription "Morning After Pill" - August 1, 2006
Emergency Contraception (the "Morning After Pill"): Why it Matters in the Debate Over Abortion - FNC - March/April 2009