HHS overrules expanded availability of Plan B

February 1, 2012

US Health and Human Services (HHS) Secretary Kathleen Sebelius overruled the Food and Drug Administration (FDA) by refusing to allow emergency contraceptive Plan B One-Step to be sold over the counter to women younger than 16. It is the first time a health secretary has ever overruled the FDA.

US Health and Human Services (HHS) Secretary Kathleen Sebelius overruled the Food and Drug Administration (FDA) by refusing to allow emergency contraceptive Plan B One-Step to be sold over the counter to women younger than 16. It is the first time a health secretary has ever overruled the FDA.

Scientists and politicians have disagreed for years about whether to make Plan B available over the counter. After initially rejecting over-the-counter availability for women of any age, the Bush administration agreed to allow women 18 years old and older to purchase it without a prescription, and in 2009 the Obama administration lowered the age to 17.

FDA Commissioner Margaret Hamburg, MD, argued that Plan B was safe to sell over the counter, noting that the administration's scientists had "determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted disease." But HHS Secretary Sebelius claimed that the drug's manufacturer had failed to study whether girls as young as 11 years could use Plan B safely, a necessity, she said, because 10% of girls of this age can bear children.