“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.