FDA CHANGES STANCE ON OTC PLAN B

Pharmacy Times, Volume 0, 0

Women aged 18 and older may soon beable to access emergency contraceptionwithout a prescription.

The FDA has announced that its officialswill meet "immediately" with officials ofBarr Pharmaceuticals Inc, the makers of the"morning-after" pill, also called Plan B (levonorgestrel),to discuss ways to make thedrug available to women 18 and older overthe counter. Plan B currently is availableonly with a prescription to women aged 16and older. "This decision is the result of athoughtful and comprehensive scientificand public policy process undertaken by theagency," the announcement said.

The agency said in a letter to Barr that areview had concluded that no rule makingwas necessary, clearing the way for finalconsideration of Barr's application for OTCstatus for Plan B. The letter also stated that,if Barr could meet certain restrictions, itwould allow OTC sales of the drug towomen 18 and older, but the drug companymust assure the FDA that it will enforcea program to restrict sales.

Part of the program states that Plan Bwould not be available at places such asconvenience stores or gas stations, butonly at stores where there is a pharmacy.The drug would be kept behind the pharmacycounter, and women requesting thedrug would have to show proof of age inorder to purchase it.

A spokeswoman for Barr stated that thecompany did not yet know how quickly itcould get the OTC version of the product tomarket, once final approval is granted—which the FDA hopes will "be wrapped upin a matter of weeks."

Plan B currently costs about $25 per prescription,but the company would probablyhave to charge more than amount that foran OTC version to counter the costsinvolved with monitoring the sales, thespokeswoman said.

Laws in 9 states presently allow pharmaciststo dispense Plan B without a prescriptionunder certain conditions. Barr's spokeswomansaid, "We think this is a positivedevelopment.We will see how the meetinggoes and move forward from there."