Posted on behalf of Meredith Wadman
In a surprise move, the US secretary of Health and Human Services (HHS), Kathleen Sebelius, has overruled her own Food and Drug Administration (FDA) commissioner on a sensitive political issue, denying girls under 17 access to the emergency contraceptive Plan B unless it is prescribed by a physician.
Plan B (levonorgestrel), better known as the “morning after pill,” is taken after unprotected intercourse. It is believed to work by interfering with the transport of sperm and ova in the fallopian tube, or by preventing uterine implantation of a fertilized egg. Conservatives have objected to its use by young girls in the belief that it encourages promiscuity. Others who maintain that life begins at conception have opposed it on those grounds.
Plan B is currently available with a prescription to girls 16 and younger. Since 2009, it has been available to females 17 and older behind the pharmacy counter. In February, Plan B’s manufacturer, Teva Women’s Health, applied to the FDA asking the agency to make the pill available over-the-counter to all girls and women regardless of age.
On 7 December, Sebelius ordered FDA to deny the application and issued a statement explaining that, contrary to FDA expert opinion, she does not believe that the pill can be used safely by the youngest girls of reproductive age. Noting that about 10% of girls are capable of bearing children by 11.1 years of age, she wrote that while the science has confirmed the drug to be safe and effective with appropriate use, “It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.”
She added that the company did not provide enough age-appropriate data to FDA to “conclusively establish” that it should be made available over the counter to girls younger than 17.
In a statement issued the same day, FDA commissioner Margaret Hamburg responds by noting that the agency’s Center for Drug Evaluation and Research had considered the data presented by the company and determined that the pill was safe and effective in all adolescent girls. They also found, she wrote, that “the data supported a finding that adolescent females could use [Plan B] properly without the intervention of a healthcare provider.”
Nonetheless, she wrote, she was compelled by Sebelius’s order to deny Teva’s application to make Plan B available over-the-counter.
Reproductive health services provider Planned Parenthood, in a written statement, pronounced itself “extremely disappointed” with Sebelius’ decision.
Research “has shown that teens understand that emergency contraception is not intended for regular use and that the rates of unprotected sex do not increase when they have easier access to emergency birth control,” said Vanessa Cullins, the organization’s executive vice president for external medical affairs. She cited, for instance, this study in the journal Obstetrics and Gynecology, which found that girls younger than 16 with access to the pill behaved no differently in response to increased access to the pill from older girls and women. In particular, they did did not show increases in unprotected intercourse, sexually transmitted infection acquisition, or pregnancy.
The drug has been a political hot potato since the George W. Bush administration, when Susan Wood, the director of FDA’s Office of Women’s Health, resigned in protest after the Bush administration overruled a previous FDA decision to make the pill available over-the-counter to females 17 and older.
Wood, now an associate professor health policy at George Washington University, told Nature she was “stunned” by the decision, especially in view of President Barack Obama’s 2009 presidential memorandum on scientific integrity. That memo opened by declaring that “Science and the scientific process must inform and guide decisions of my administration.”
Says Wood of Sebelius’ order: “The arguments she makes make no sense if you know the data and you know the literature. I don’t know why this administration, which committed itself to scientific integrity, would take such an action.”