The Obama administration stunned women’s health advocates and abortion opponents alike Wednesday by rejecting a request to let anyone of any age buy the controversial morning-after pill Plan B directly off drugstore and supermarket shelves.
For what the Food and Drug Administration thinks is the first time, the Department of Health and Human Services overruled the agency, vetoing the FDA’s decision to make the contraceptive available without any restrictions. Revealing a rare public split, FDA Administrator Margaret A. Hamburg said her conclusion that the drug could be used safely by women of all ages was nullified by Health and Human Services Secretary Kathleen Sebelius.
“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 child-bearing potential,” Hamburg said in a statement.
“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.”
In a statement and separate letter to Hamburg, Sebelius said she reversed the FDA’s decision because she had concluded that data submitted by the drug’s maker did not “conclusively establish” that Plan B could be used safely by the youngest girls.
“About ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” Sebelius said.
Her action means that instead of being able to pick up Plan B off store shelves, like condoms and spermicides, girls 16 and younger still need a doctor’s prescription to obtain it. Women 17 and older can buy the pill without a prescription but must show proof of age to a pharmacist.
The decision shocked and angered the doctors, health advocates, family-planning activists, lawmakers and others who supported relaxing the restrictions to help women, including teenagers, prevent unwanted pregnancies.
“We are outraged that this administration has let politics trump science,” said Kirsten Moore of the Reproductive Health Technologies Project, a Washington-based advocacy group. “This administration is unwilling to stand up to any controversy and do the right thing for women’s health. That’s shameful.”
Susan F. Wood of George Washington University, who resigned from the FDA in 2005 because of delays by the George W. Bush administration in relaxing restrictions on Plan B, said she was “beyond stunned” by the decision.
“There is no rationale that can justify HHS reaching in and overturning the FDA on the decision about this safe and effective contraception,” Wood said. “I never thought I’d see this happen again.”
Opponents of easier access, meanwhile, hailed the decision, saying relaxing the rules would have exposed girls and women to risks from taking high doses of a potent hormone and misusing the medication; interfered with parents’ ability to monitor their children; and made it easier for men to prey on vulnerable minors.
“Plan B can act in a way that can destroy life,” said Jeanne Monahan of the Family Research Council, a conservative advocacy group. “A decision to make Plan B available for girls under the age of 17 without a prescription would not have been in the interest of young women’s health.”
A long controversy
Plan B has long been controversial and was the focus of one of the most contentious health disputes during the Bush administration. It works primarily by preventing an egg from being fertilized. But critics focus on the chance that it might prevent a very early embryo from implanting in the womb, an action they consider equivalent to an abortion. As a result, some doctors refuse to write prescriptions for it, some pharmacists refuse to fill requests, and some hospitals refuse to provide it to patients.
Wednesday’s decision came as the administration is trying to defuse rising tensions with the Catholic Church over several issues, including a proposed mandate that private insurers provide women with contraceptives for free and a federal denial of an anti-human-trafficking grant to the U.S. Conference of Catholic Bishops.
“I welcome the . . . decision not to expand nonprescription use of Plan B to all minors of childbearing age,” said the conference’s Deirdre McQuade. Plan B “could endanger the lives of newly conceived children through its abortifacient action, put minors at risk for unnecessary side effects, undermine parental rights and contribute to higher STD [sexually transmitted disease] rates.”