FDA Sends Plan B Back to the Drawing Board

Pharmacy Times, Volume 0, 0

Community pharmacists will not be selling the controversial Plan Bemergency contraceptive OTC—at least not this year. If the drug ever doeswin approval for nonprescription status, pharmacists may be called on tocheck the identity of purchasers.

Despite pressure from pro-choice groups to make the so-called "morningafterpill" available to women without a prescription, FDA officials raised concernsabout the possible use of such a product by adolescent girls. In issuing a"Not Approvable" letter to Plan B sponsor Barr Laboratories, the FDA said thatthe company needs to conduct more research on the use of that product bygirls younger than 16. "The sponsor's application contained no data on subjectsunder 14 years of age and very limited data on adolescents 14 to 16 yearsold," the agency letter said.

The FDA letter also said that Barr's application failed to include "adequatedata to support use of Plan B by young adolescent women without the interventionof a physician."

The manufacturer is working to address the FDA's concerns. It is expectedto issue a new proposal under which the drug would be sold OTC towomen 16 and older, but by prescription only to those under 16.