In a move that continues restrictions on a morning-after birth control pill, Health and Human Services Secretary Kathleen Sebelius Dec. 7 vetoed a Food and Drug Administration decision to allow unrestricted over-the- counter sales of Plan B One-Step, an emergency contraceptive.
The HHS secretary’s action, endorsed Dec. 8 by President Obama, overturned FDA approval of a request by Plan B maker Teva Pharmaceutical Industries to make the compound, now available without a prescription to those above 17 years old, available to all age groups.
According to the New York Times, Sebelius’ said, “I have concluded that the data submitted by Teva do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.”
According to a report from Reuters, a FDA spokesperson said the agency being overruled by the HHS Secretary was unprecedented. The FDA was finally coming on board with what women’s health advocates have been requesting for the medication over the last eight years – to increase the ease of access to the pill for women who need it.
Because a prescription is required for people under 17, the drug is kept behind the counter, meaning everyone who asks for it has to show ID.
Sebelius said she thinks this continues to be necessary, according to FoxNews, because the product packaging and instructions could be confusing to girls as young as 11 years old, who could be in need of the product.
The move surprised Dr. Robert Block of the American Academy of Pediatrics who described the Sebelius’ decision to FoxNews as “medically inexplicable.” Dr. Cora Breuner, an AAP member, referencing the costs said, “I don’t think 11-year-olds go into Rite Aid to buy anything.”
Obama gave his “wholehearted support” to the decision, according to the New York Times. “The reason Kathleen made this decision,” the president told reporters at the White House, “is that she could not be confident that a 10-year-old or an 11-year-old going to a drug store should be able — to buy a medication that potentially, if not used properly could have an adverse effect. And I think most parents would probably feel the same way.”