FDA Advisory Committees Vote to Allow Over-the-Counter Sale of Emergency Contraceptive
Tuesday, December 16, 2003 05:52 PM ET Printer-friendly version
Increased Access to Plan B® Product Could Significantly Reduce Abortions
WOODCLIFF LAKE, N.J., Dec. 16 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc. (NYSE: BRL, news) and Women's Capital Corporation (WCC) today announced that two U.S. Food and Drug Administration (FDA) Advisory Committees have recommended that Plan B®, now available by prescription only as an emergency contraceptive, be permitted to be sold without a prescription. The recommendation came following a joint meeting of the FDA's Nonprescription Drugs and Reproductive Health Drugs Advisory Committees. The FDA will now consider the recommendation. In presentations to the committees, Barr and WCC, among others, stated that increased education about the availability of the Plan B emergency contraceptive, and lowering of barriers that delay access, could eliminate more than 50% of unintended pregnancies.
The recommendation of the Advisory Committees represented a vote of 23 to 4 in favor of allowing Plan B emergency contraceptive to be sold Over-The-Counter (OTC) without a prescription.
"We are very pleased with today's recommendation by the Advisory Panel for OTC status for the Plan B emergency contraceptive. If ultimately approved by the FDA, OTC access to Plan B will provide women who have had unprotected sexual intercourse and do not want to become pregnant with an additional contraceptive option," said Carole Ben-Maimon, M.D., President and Chief Operating Officer of Barr Research, the Company's proprietary product development organization.
"Barr is committed to lowering the barriers that prevent women from being able to access this option in a timely manner. In many cases, being able to receive a prescription currently prevents the timely use of this method of contraception," Dr. Ben-Maimon continued. "Making the product available without prescription would reduce these barriers and would represent a significant public health service to American women."
The Company presented to the Advisory Committees an extensive education program for physicians and other healthcare professionals, as well as an array of educational materials that will be available for women who have questions about Plan B or its appropriate use. These include consumer-friendly labeling, a website, and a 24 hour hotline that will connect consumers directly with trained healthcare professionals to answer any questions.
Taken within 72 hours of unprotected intercourse, Plan B® has been shown to reduce the risk of pregnancy by 89 percent after a single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment increases. Taken in the first 24 hours after intercourse, Plan B can prevent 95 percent of expected pregnancies. 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 100 countries, 33 of which do not require a prescription. Emergency contraception is currently available in a limited number of pharmacies in five U.S. states (Alaska, California, Hawaii, New Mexico and Washington) without an advance prescription from a physician or healthcare provider.
"If approved by FDA as an OTC product, Plan B would be sold in single use packages that would deter it from being used as a 'routine' form of birth control," said Dr. Ben-Maimon. "In addition, bleeding patterns associated with repeated use of Plan B make frequent use impractical."
Contraindications for Plan B
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 however, 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.
Barr, Women's Capital Corporation
In October 2003, Barr announced that it had signed a letter of intent to acquire the emergency oral contraceptive, Plan B, and certain other assets and liabilities of the Women's Capital Corporation (WCC), a Washington, DC-based privately held company. Financial terms of the prospective acquisition were not disclosed. This transaction is subject to certain conditions including negotiation of definitive agreements, which Barr and WCC expect to complete by February 1, 2004.
WCC was organized in 1997 to develop and market reproductive health products of critical importance to women.
Barr Laboratories, Inc. is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
Forward-Looking Statements
The following sections contain a number of forward-looking statements. To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by their use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; the success of our product development activities; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing; the ability to develop and launch new products on a timely basis; the availability of raw materials; the availability of any product we purchase and sell as a distributor; our mix of product sales between manufactured products, which typically have higher margins, and distributed products; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing new enterprise resource planning systems; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; and other risks detailed from time to time in our filings with the Securities and Exchange Commission..
Source: Barr Laboratories, Inc.
Contact: Carol A. Cox of Barr Laboratories, Inc., +1-201-930-3720, ccox@barrlabs.com |
