The Food and Drug Administration has denied an application by a pharmaceutical firm to make the emergency contraceptive known as Plan B available without a doctor’s prescription. That decision contravenes recent recommendations from an FDA advisory panel and from some FDA staff members who reviewed data on the so-called morning-after pill, which consists of two high doses of the hormone levonorgestrel.
The drug’s possible switch to nonprescription status has raised the ire of groups that maintain that making the emergency contraceptive available over the counter would encourage unsafe sex.
Studies provided to the FDA by the drug’s maker, Barr Pharmaceuticals of Bala Cynwyd, Pa., don’t support that contention, but the participants in those studies were almost all women over the age of 16. At a May 7 news conference, Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, cited his concern about “sparse” data on the safety of levonorgestrel in adolescent girls 14 to 16 years old and the absence of safety information in girls 11 to 14.
The FDA and Barr Pharmaceuticals haven’t yet discussed what sorts of data would be needed to reverse the denial of Plan B for over-the-counter sales.