Barr Pharmaceuticals, Inc. and Women's Capital Corporation (WCC) said that the US Food and Drug Administration (FDA) has extended the original 10-month Prescription Drug User Fee Act (PDUFA) deadline for completion of its review of the Plan B Supplemental New Drug Application (sNDA). Barr and WCC are seeking approval to market the Plan B emergency contraceptive Over-The-Counter (OTC) without a prescription. The PDUFA extension will permit the FDA to complete its review of the application, including additional data on adolescent use that was submitted by Barr and WCC in support of the application.
Based on its ongoing dialogue with FDA, Barr indicated that it is expecting a decision regarding OTC status for the Plan B emergency contraceptive within 90 days of the original February 20, 2004 PDFUA date. The Plan B emergency contraceptive is currently available by prescription only.
"We will work with the agency to assist in the timely completion of the review and we are committed to providing any additional data that they may need to reach a decision," said Bruce Downey, Barr's CEO. "We believe that availability of the Plan B emergency contraceptive as an OTC product meets a significant unmet medical need, and that OTC status will remove barriers that currently delay the timely availability of Plan B for women who have had unprotected sexual intercourse or experienced a contraceptive failure."
On December 16, 2003 two FDA Advisory Committees recommended by a vote of 23 to 4 that the FDA approve the request to change the status of Plan B emergency contraceptive from prescription only to OTC.
Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89 per cent after a single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment increases. Plan B is most effective when taken in the first 24 hours after intercourse. The decline in efficacy from a delay in treatment is why a broad range of health professionals believe that barriers to more timely access to Plan B should be removed, including making the product broadly available without prescription.
Emergency contraception is currently available in 101 countries, 33 of which do not require a prescription. Emergency contraception is currently available in a limited number of pharmacies in five US states (Alaska, California, Hawaii, New Mexico and Washington) without an advance prescription from a physician or healthcare provider.
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B regimen consisting of the emergency use of two progestin pills. POPs are not recommended for use in the following conditions: known or suspected pregnancy; hypersensitivity to any component of the product; and, undiagnosed abnormal genital bleeding.