Plan B, the emergency oral contraception, should have been available completely over the counter years ago.
The American Medical Association, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics have all endorsed making Plan B available OTC.
Plan B is already available in 31 countries without requiring a prescription, and in 2003 an FDA advisory committee recommended the medication be approved for OTC sale in the United States. In 2006, the Bush administration approved Plan B for “behind the counter” sales — women 17 and older could obtain it from a pharmacist without a prescription, but women under 17 still require a prescription.
Not surprisingly, the Bush administration caved to its anti-abortion base and rejected the recommendation. What was surprising, however, was that the Obama administration also decided to put politics above science and in 2011 Secretary of Health and Human Services Kathleen Sebelius announced that she also was rejecting the FDA’s recommendation that Plan B be sold over the counter.
FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.
The Secretary of the Department of Health and Human Services is responsible, acting through the FDA Commissioner, for executing the Federal Food, Drug, and Cosmetic Act. Today’s action reflects my 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. Plan B One-Step will still be available over the counter to women ages 17 and older.
Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc.
Apparently, the Obama administration believed this decision would give them political cover to address other women’s issues that they deemed more critical.
Anyway, US District Court Judge Edward R. Korman was having none of it,
This case is not about the potential misuse of Plan B by 11-year-olds. These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-7olds using these drugs is likely to be miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed. Instead, the invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions
Secretary Sebelius’s directive to the FDA to reject the Plan B One-Step SNDA forced the agency to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability.
Add the war on science to yet another crazy Bush war that Obama insisted on continuing.