The Food & Drug administration had decided to make the abortifacient “morning after” pill available over the counter without a prescription. But now the Health & Human Services Department has over-ruled that decision, keeping the drug by-prescription only:
The federal government Wednesday rejected a request to let young teenage girls buy the controversial morning-after pill Plan B directly off drugstore and supermarket shelves without a prescription.
In a rare public split among federal health officials, the Health and Human Services Department overruled a decision by the Food and Drug Administration to make the drug available to anyone of any age without a restriction.
In a statement, FDA Administrator Margaret A. Hamburg said she had decided the medication could be used safely by girls and women of all ages. But she added that Health and Human Services Secretary Kathleen Sebelius had rejected the move.
“I agree … 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.
“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,” she said.
In a separate statement and letter to Hamburg, Sebelius said she overruled the FDA because she had concluded that data submitted by the company that makes the drug did not “conclusively establish” that it could be used safely by girls of all ages.“About 10 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. “If the application were approved, the product would be available, without prescription, for all girls of reproductive age.”
The surprising decision is a stunning blow to some doctors, health advocates, family-planning activists, members of Congress and others who backed relaxing the restrictions to help women prevent unwanted pregnancies.
How safe it is. . . but it isn’t safe for unborn children.