Sebelius overturns FDA on morning after pill access

By Dr. Ananya Mandal, MDDec 8 2011

Health and Human Services Secretary Kathleen Sebelius this Wednesday overturned the Food and Drug Administration's (FDA) plan to remove the age limit on who can buy Teva Pharmaceutical Industries Ltd's Plan B One-Step pill – commonly known as the “morning after pill” without a prescription.

The pill, which has to be taken within 72 hours of unprotected sexual intercourse, has been available without a prescription to women over 17, but they have to still ask a pharmacist for help and show identification for an age check. Girls under 17 need a prescription to buy the drug.

The FDA expressed surprise at the move. An FDA spokeswoman said no health secretary has ever overruled the agency. The FDA itself has drawn fire in the past for being slow to expand access to the morning-after pill. FDA approval would have likely put the morning-after contraceptive on drugstore shelves next to condoms and other family-planning products.

“The whole thing is extraordinary and does not make any sense,” said Susan Wood, former head of the FDA's Office of Women's Health who resigned in protest over the agency's handling of the drug in 2005. “I had come to believe that the FDA would be allowed to make decisions based on science and the public's health. Sadly, once again, FDA has been overruled and not allowed to do its job,” Wood said. FDA experts, including gynecologists and pediatricians “reviewed the totality of the data (on Plan B) and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential,” Margaret Hamburg, FDA Chief, said in a statement.

The move is the latest effort in a decade-long battle over the pill, which critics say could lead to promiscuity, sexual abuse and fewer important doctor visits if readily available for purchase. Advocates for such emergency pills say they help reduce unwanted pregnancies or abortions and that quick, easy access for women of all ages is critical for the medicines to work.

“Politically, contraception is a flash point...but in the medical community and the general public, it is a normal part of daily lives. We had thought that Secretary Sebelius understood that,” said Amy Allina, who leads advocacy work at the non-profit National Women's Health Network.

Sebelius highlighted that while on average girls reach reproductive age by 12.4 years, some are capable of bearing children at 11.1 years. “It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non- prescription availability of this product for all ages,” Sebelius wrote Hamburg in a memo today.

“The Secretary made this decision,” an administration official said when asked whether it was made by Sebelius alone. When asked whether she consulted in advance with President Barack Obama or with the White House, the official would only add, “Agencies routinely consult/inform the White House about a wide range of issues and decisions.”

But Dr. Lisa Flowers, associate professor in the Department of Obstetrics and Gynecology at Emory University's School of Medicine, said Sebelius' decision “might be the right thing to do until we get a really good system by which we can educate young kids about prevention of pregnancy and understanding the risks of getting involved in sexual intercourse, and what are the outcomes.” Flowers suggested the FDA consider allowing over-the-counter access for girls under the age of 17 if they are accompanied by a parent to the drugstore.

Teva expressed its disappointment at the last-minute HHS action. “We commend the FDA for making the recommendation to approve providing women with increased over-the-counter access,” the Petach Tikva, Israel-based company said in the statement. “We are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion.” The company's sales of Plan B One-Step last year reached $80 million, according to IMS Health data.

Plan B One-Step is made with levongestrel, an ingredient found in birth control pills, and is linked with side effects that can include nausea, dizziness, changes in menstrual periods and fatigue.