Sebelius overrules FDA on 'morning after' pill's OTC availability

Dec 9 2011

The decision to keep the contraceptive pill "Plan B" behind the counter could shield the Obama administration from a bruising battle with conservatives but comes at the expense of liberal groups who are "shocked" at the decision.

The New York Times: Plan To Widen Availability Of Morning – After Pill Is Rejected
For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives to be sold over the counter, including to young teenagers. The decision avoided what could have been a bruising political battle over parental control and contraception during a presidential election season (Harris, 12/7).

NPR: Women's Groups Outraged By Ruling On Morning-After Pill
Women's health advocates were quick to cry foul Wednesday when Health and Human Services Secretary Kathleen Sebelius overruled the opinion of the Food and Drug Administration that the popular "morning after" emergency contraceptive "Plan B One Step" should be allowed to be sold without a prescription -; and without age restriction (Rovner, 12/8).

The Wall Street Journal: Obama Health Chief Blocks FDA On 'Morning After' Pill
The move inserted the Obama administration into the long-running controversy over how much the federal government should restrict access to Plan B, a so-called morning-after pill that can stop pregnancy up to three days after intercourse. Allowing girls under age 17 to buy the $50 pill over the counter could have saddled the Obama administration with a political target as the 2012 presidential campaign moves into full swing (Dooren, 12/8).

The Baltimore Sun: Morning After Pill Won't Be Available Without A Prescription
Plan B One-Step is currently labeled over the counter for women aged 17 or older, but it is sold behind the counter. Girls aged 16 years and younger can only get the pill with a prescription. The maker of the drug, Teva Women's Health, had applied to the Food and Drug Administration in February to make it available over the counter to all girls of reproductive age (Walker, 12/7).

Bloomberg: Morning-After Pill Limits Marks First Time U.S. Overrules FDA
A decision by U.S. regulators to approve unrestricted over-the-counter access to Teva Pharmaceutical Industries Ltd. (TEVA)'s emergency contraceptive was overruled by the Obama administration, the first time in history for such a reversal. Secretary of Health and Human Services Kathleen Sebelius ordered Margaret Hamburg, the Food and Drug Administration chief, to reject the application by Petach Tikva. ... Hamburg said she was ready yesterday to approve sales of Plan B One-Step (TEVA) without a prescription to women of all ages based on "science-based evidence" (Edney and Armstrong, 12/8).

Boston Globe: US To Keep Morning-After Pill Restrictions
In a completely unexpected turn of events, the US Food and Drug Administration announced today that it was not going to permit the emergency contraception pill, Plan B, to be sold over the counter without any age restriction. The agency's commissioner said it had planned to lift the age restrictions but was overruled by Health and Human Services Secretary Kathleen Sebelius. In dueling press statements, the two Obama administration appointees said they came to opposite conclusions about the safety of making Plan B available to girls under age 17 (Kotz, 12/7).

The Associated Press: Block Of OTC Morning-After Pill Sparks Debate
It was the latest twist in a nearly decade-long push for easier access to pills that can prevent pregnancy after unprotected sex, and one with election-year implications. The move shocked women's health advocates, a key part of President Barack Obama's Democratic base, as well as major doctors groups that argue over-the-counter sales could lower the nation's high number of unplanned pregnancies (Neergaard, 12/8).

The Hill: Left 'Speechless' As Seblius Overrules FDA On Access To Morning-After Pill
In a decision steeped in 2012 politics, President Obama's top health official on Wednesday overruled government scientists to block wider access to the so-called "morning-after pill." The decision to leave in place a requirement that women younger than 17 get a prescription for the drug was a huge surprise to liberal groups and advocates for the Plan B contraceptive, some of whom said they were left "speechless" by Health and Human Services Secretary Kathleen Sebelius's involvement (Baker, 12/7).

Politico: Contraceptive Rule A Pill For Obama
President Barack Obama is facing a decision that could threaten inroads he made in 2008 with Catholic voters and other religious voters. But this time, the issue isn't abortion. It's contraception (Feder, 12/7).

National Journal: HHS Decision Tarnishes Obama's Pledge To Put Science First
The month before the stem cell decision, Obama's HHS rescinded Bush conscience exemptions that had allowed hospitals and doctors to pass on giving patients advice on family planning, particularly emergency contraception, which anti-abortion groups view as abortion. But Wednesday's move by Health and Human Services Secretary Kathleen Sebelius to overrule the Food and Drug Administration on the morning-after pill opens the administration up to accusations of political bias. Congress could, in theory, override the decision, but the actual chances this would happen are zero. Sebelius's move was clearly galling to medical experts. FDA Commissioner Margaret Hamburg, a physician and public health expert, broke the news in an unusual statement that first said she had OK'd the over-the-counter sale of morning-after contraception to all women (Fox, 12/7).