In a surprising move that opens the Obama administration to accusations of putting politics above science, Health and Human Services Secretary Kathleen Sebelius has overruled the Food and Drug Administration’s decision that would have allowed any woman, including teens under the age of 17, to get a morning-after birth-control pill without a prescription.
Advocates immediately cried foul, and senior Democrats on the Hill expressed disappointment that the Obama administration would intervene on such a sensitive matter.
In an unusual statement, FDA Commissioner Dr. Margaret Hamburg said she had decided that certain forms of morning-after contraception would be safe for younger teens to use, and they could understand how to use them. She was prepared to approve the pills for over-the-counter sales to all women.
"However, this morning I received a memorandum from the secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential," Hamburg said in the statement.
An FDA spokeswoman said she could not recall HHS ever before overruling FDA in this way.
In a separate statement, HHS Secretary Kathleen Sebelius said she worried that approval would have allowed girls as young as 11 to buy birth control on their own.
Democrats on the hill expressed immediate disappointment.
"The FDA is a science-based organization, and I think they gave her their recommendations based on the science, and I wish she had followed it,” Energy and Commerce ranking member Henry Waxman, D-Calif., whose committee has jurisdiction over HHS and FDA, said in an interview.
Rep. Louise Slaughter, D-N.Y., the ranking member on the Rules Committee and a cochair of the Pro-Choice Caucus, said she regretted the administration’s decision. “We were really thinking it would make a major difference. I’m very disappointed,” Slaughter said in an interview.
Advocates went further, saying it was a case of politics trumping science – an accusation last made against the Republican administration of former President George W. Bush. “There is no rationale for this move,” Kirsten Moore of the Reproductive Health Technologies Project told the Associated Press. “What else can this be but politics?” asked Cynthia Pearson, executive director of the National Women’s Health Network. “It’s not science. It’s not medicine. It’s not women’s health.”
FDA had been due to report Wednesday on applications to make it easier to get emergency contraceptives, such as one called Plan B One-Step.
The single-dose pills contain higher levels of a hormone used in once-a-day birth control pills. Taken within three days of unprotected sex, they can prevent pregnancy. In 2009, FDA approved Plan B for sale over the counter, but only to women over 17 who produced ID. Teens 16 and under would need a prescription to get it.
In 2009, a New York district judge ruled the FDA’s age limit was “arbitrary and capricious” and likely influenced by politics. He ordered the FDA to reconsider --something the agency didn’t do, and advocates had sued again, with a hearing on the matter scheduled for next week.
Drug-maker Teva asked FDA this year to approve a fully over-the-counter version of the pill. Women's-health advocates argued that the pills could be used safely and that teenage girls who are already sexually active are very unwilling to see a doctor for last-minute contraceptive prescriptions.
"The Center for Drug Evaluation and Research carefully considered whether younger females were able to understand how to use Plan B One-Step," Hamburg said.
"Based on the information submitted to the agency, CDER 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 diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a health care provider."
Hamburg said she agreed that the product was safe and should be available to all women over the counter. But Sebelius overruled her.
"Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17," Hamburg said.
Sebelius said she reviewed Hamburg’s report but decided the data did not cover all age groups of girls who might use the drug. “Yet, 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.
She noted that 10 percent of U.S. girls reach puberty at age 11 and could in theory get the pill under any new FDA approval.
Planned Parenthood’s Dr. Vanessa Cullins said the decision could make it harder to fight the United States’s historically high teen birth and abortion rates.