Plan B: Sebelius Overrules FDA, Nixes Sale Without ID

Dec. 7, 2011 -- Plan B One-Step -- the emergency contraceptive "morning-after pill" -- will remain hidden behind pharmacy counters. Girls under age 17 will still need a prescription.

Teva Pharmaceuticals had petitioned the FDA to allow stores to put Plan B on shelves with other family-planning products -- and to sell it to anyone who wanted it. The company conducted a study it said showed that girls as young as 12 could understand how to safely use the single-pill product.

The FDA agreed. In a statement released today, FDA Commissioner Margaret Hamburg, MD, said "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of childbearing potential."

But in an extremely unusual action, HHS Commissioner Kathleen Sebelius -- Hamburg's boss -- overruled the FDA.

Sebelius noted that about 10% of girls are able to get pregnant at age 11. In a statement, Sebelius said her 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."

The studies submitted to FDA, as published, included girls aged 12 to 17. At least 79% of the youngest girls could understand the instructions.

By the time a girl gets a prescription for Plan B, it may be too late. The drug must be taken within three days -- 72 hours -- of unprotected sex.

"The sooner Plan B is taken, the better it works," Amy Niemann, vice president of Teva Women's Health, tells WebMD. "That is the entire rationale for having widespread availability for this product."

Nancy L. Stanwood, MD, MPH, section chief of family planning at Yale School of Medicine, says full OTC status would have made emergency contraception available to many more people who need it.

"The irony of Plan B not being OTC for women of all ages is that it has not been available for the women who need it the most," Stanwood tells WebMD. "Teens may be sexually active for a while before they see a doctor to get a prescription for contraceptives. ... [With emergency contraceptives] they don't just have to hope the condom doesn't break. There is something they can do."

And there's another group of women that may want emergency contraception: rape victims.

"Many women who have been raped do not come in for medical care, and many do not see a doctor in a timely manner," Stanwood says. "With over-the-counter sale of Plan B, at least they could do this. And young women are more likely to be raped. We want these women to get medical care, but most do not do it quickly."