FDA to again decide on OTC switch for Plan B contraceptive
The FDA may decide as soon as this week on whether pharmacies can sell the Barr Pharmaceuticals' emergency contraceptive, Plan B, without a prescription to women age 16 and older, a Wall Street Journal report said.
Last May, the FDA rejected non-prescription sales of emergency contraceptives.
At the time, the FDA told Barr it could submit more data on girls under 16 years old or it could revise its application to market the drug only to females over 16. If Barr chooses the latter, it would have to submit information on how to make the age restriction work. In July, Barr again applied for approval. The company now proposes that drug stores check customers' ages to be certain that buyers are at least 16, an approach the FDA hasn't approved before. Younger teenagers could continue to get the drug with a doctor' s prescription.
Preparing for an OTC switch, Barr has been working with IQ Design in New York on a campaign to promote a better understanding of the drug.
A limited number of states already offer the drug without a prescription – Alaska, California, Hawaii, Maine, New Mexico and Washington.