Agency to Initiate Rulemaking Proceeding on 'Dual Label' Concept
WOODCLIFF LAKE, N.J. — Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that it has received a letter from the U.S. Food and Drug Administration (FDA) concerning the Company's Supplemental New Drug Application (sNDA) seeking Over-the-Counter (OTC) status for its Plan B(R) emergency contraceptive product. The letter states that "the Center for Drug Evaluation and Research ... has completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an OTC product ... for women who are 17 years of age and older." Notwithstanding this clear scientific determination, the FDA has delayed any action on the application. Instead, the FDA informed the Company that it intends to seek public comment on issues related to the approval of a product that has OTC status for patients 17 and older and prescription status for patients 16 and under. In its communication with the Company, the FDA did not commit to any timetable for initiating or concluding the rulemaking proceeding.
"We are disappointed that the FDA did not approve our application. In our submission to the FDA we provided a detailed legal analysis supporting approval of a dual label product and continue to believe that a dual label status can and should be approved for Plan B," said Bruce L. Downey, Barr's Chairman and CEO. "While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B as an OTC/Rx Product."
Plan B emergency contraceptive will remain in the market as a prescription drug product during these proceedings.
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. Plan B is more 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 102 countries, 34 of which do not require a prescription. Emergency contraception is currently available through pharmacy access programs in some pharmacies in seven U.S. states (Alaska, California, Hawaii, Maine, New Hampshire, New Mexico and Washington).
Contraindications for Plan B(R)
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.
Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.
Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: 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 outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; 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 on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; 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 our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2004.
The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.
SOURCE Barr Pharmaceuticals, Inc.
May 12, 2014