FDA delays Plan B decision

October 1, 2005

A decision on Barr Lab's application for over-the-counter (OTC) status for Plan B has been postponed by the FDA, which previously had promised action by September 1.

A decision on Barr Lab's application for over-the-counter (OTC) status for Plan B has been postponed by the FDA, which previously had promised action by September 1. Citing a need for more time to figure out how to regulate an emergency contraceptive (EC) that would be both prescription and OTC, the agency ordered a 60-day public comment period, which ends November 1.

In an August 26 statement, FDA Commissioner Lester M. Crawford would not commit to a new date for a final decision on Plan B. The FDA Center for Drug Evaluation and Research (CDER), however, has concluded that "the available scientific data are sufficient to support the safe use of Plan B as an over-the-counter product, but only for women who are 17 years of age or older."

Three issues remain to be resolved before it can rule on Plan B, says the FDA:

Find out how your colleagues feel about OTC status for Plan B and give us your opinion by visiting our online survey at http:// http://www.contemporaryobgyn.net/.

(For a personal perspective on Plan B, read Dr. Lockwood's editorial.)