U.S. regulators have extended their review of an application to make the Plan B ”morning after pill” available without a prescription, Barr Pharmaceuticals Inc. said on Friday.
Barr, in a statement, said it expects a decision from the Food and Drug Administration within 90 days of the original deadline, which was next Friday.
Plan B, an emergency contraceptive that may prevent pregnancy when taken within 72 hours of sexual intercourse, now is available only by prescription.
Political pressure
Barr spokeswoman Carol Cox said the FDA recently requested additional information about use of Plan B by adolescents, and she believed the agency wanted more time to study that data.
“I don’t think it’s unusual to have that happen,” she said.
In December, a Food and Drug Administration advisory committee voted 23-4 in favor of making Plan B available without a prescription. Requiring a prescription presents too many hurdles for women to get the product in time, supporters of the switch said.
The FDA is under political pressure to keep Plan B as a prescription-only product. Several lawmakers have voiced their opposition to a switch.
Barr is in the process of acquiring Plan B from privately held Women’s Capital Corp.
