/publications/issue/2006/2006-08/2006-08-5746

FDA CHANGES STANCE ON OTC PLAN B

Author:

Women aged 18 and older may soon be able to access emergency contraception without a prescription.

The FDA has announced that its officials will meet "immediately" with officials of Barr Pharmaceuticals Inc, the makers of the "morning-after" pill, also called Plan B (levonorgestrel), to discuss ways to make the drug available to women 18 and older over the counter. Plan B currently is available only with a prescription to women aged 16 and older. "This decision is the result of a thoughtful and comprehensive scientific and public policy process undertaken by the agency," the announcement said.

The agency said in a letter to Barr that a review had concluded that no rule making was necessary, clearing the way for final consideration of Barr's application for OTC status for Plan B. The letter also stated that, if Barr could meet certain restrictions, it would allow OTC sales of the drug to women 18 and older, but the drug company must assure the FDA that it will enforce a program to restrict sales.

Part of the program states that Plan B would not be available at places such as convenience stores or gas stations, but only at stores where there is a pharmacy. The drug would be kept behind the pharmacy counter, and women requesting the drug would have to show proof of age in order to purchase it.

A spokeswoman for Barr stated that the company did not yet know how quickly it could get the OTC version of the product to market, once final approval is granted— which the FDA hopes will "be wrapped up in a matter of weeks."

Plan B currently costs about $25 per prescription, but the company would probably have to charge more than amount that for an OTC version to counter the costs involved with monitoring the sales, the spokeswoman said.

Laws in 9 states presently allow pharmacists to dispense Plan B without a prescription under certain conditions. Barr's spokeswoman said, "We think this is a positive development.We will see how the meeting goes and move forward from there."