Plan B Remains Prescription Only for Women Age 16 Years or Younger
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In a controversial decision, the emergency contraceptive Plan B One-Step—administered as a single tablet containing levonorgestrel 1.5 mg—will remain a dual-status product, available on a nonprescription basis to women 17 years of age and older but by prescription only to women 16 years of age and younger.
In a controversial decision, the emergency contraceptive Plan B One-Step—administered as a single tablet containing levonorgestrel 1.5 mg—will remain a dual-status product, available on a nonprescription basis to women 17 years of age and older but by prescription only to women 16 years of age and younger. The decision marks the first time that the Secretary of Health and Human Services has ever publicly overruled the FDA.
In February 2011, Teva Women’s Health Inc. (manufacturer of Plan B One-Step) submitted a supplemental application seeking to make the product available on a nonprescription basis to all women of child-bearing potential. The FDA Center for Drug Evaluation and Research (CDER) recommended approval of the application, based in part on data from studies designed specifically to address whether Plan B One-Step met the regulatory standards for nonprescription drugs. According to the CDER, the data showed that adolescent females could use Plan B One-Step properly without the intervention of a health care provider.
On December 7, 2011, Secretary of Health and Human Services Kathleen Sebelius directed the FDA to deny the application, invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions. In a statement issued that day defending the decision, Secretary Sebelius explained that the label comprehension and actual use studies did not contain data for all ages for which Plan B One-Step product would be available for use (i.e., girls as young as 11 years of age physically capable of bearing children).
The statement from Secretary Sebelius and a response from FDA Commissioner Margaret Hamburg are available at the following URLs: