Plan B Pill Availability For OTC Denied By FDA

Plan B Pill – Plan B will not be an OTC (over-the-counter) birth control pill made available for younger teens, according to the Food and Drug Administration. The agency was preparing to lift the age limit that would allow people of any age to purchase the drug without a prescription. This decision is already causing some disagreements between the federal agency and the the U.S. Department of Health and Human Services.

Teva, the manufacturer of the birth control pill, requested approval from the FDA in February to make the drug available without a prescription to girls ages 16 and younger. The prescription drug is taken up to 72 hours after sex to prevent the implantation of a fertilized egg. It’s commonly known as the “morning-after” pill and available without a prescription to women 17 and older.

The product is often kept behind the pharmacy counter.

FDA commissioner Margaret Hamburg expressed support for expanding access for the drug without a prescription.

“I reviewed and thoughtfully considered the data, clinical information and analysis provided by (the Center for Drug Evaluation and Research), and I agree with the center that 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, HHS Secretary Kathleen Sebelius disagreed with the FDA’s determination.

“The switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately,” Sebelius said in a statement. “I do not believe that Teva’s application met that standard.”

In the meantime, Plan B will remain on the market and classified as a birth control pill, but girls younger than 17 must have a prescription.