FDA Rejects Over-the-Counter Emergency Contraceptive
Barr receives 'not approvable' letter for emergency contraceptive Plan B
FDA recognizes public health importance of 'wide availability' and invites additional
submissions by Barr
WOODCLIFF LAKE, N.J., May 6, 2004 /PRNewswire-FirstCall via COMTEX/ -- Barr
Pharmaceuticals, Inc. (NYSE: BRL) today announced that it has received a Not Approvable Letter
from the U.S. Food and Drug Administration (FDA) for the Company's Supplemental New Drug
Application (sNDA) for an Over-the-Counter (OTC) Plan B® emergency contraceptive product.
Although concluding that Barr's current application did "not provide adequate data to support a
conclusion that Plan B can be used safely by young adolescent women for emergency contraception
without the professional supervision of a [licensed] practitioner," the FDA offered Barr two alternative
approaches for seeking approval. First, Barr could "provide additional data demonstrating that Plan B
can be used safely by women under 16 years of age without professional supervision." Alternatively,
Barr could "supply additional information in support of a submission to allow for the marketing of Plan
B as a prescription only product for women under the age of 16 years and a nonprescription product
for women 16 years and older."
"While we are disappointed that FDA did not approve our application at this time, we are encouraged
by FDA's suggestions, and look forward to working with the agency toward approval of Plan B for over the counter use," said Bruce L. Downey, Barr's Chairman and CEO. "In the meantime, we remain
committed to providing Plan B as a prescription only product and to increasing awareness among the
healthcare provider community and women of this safe and effective option," Downey added.
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. Plan B is most effective when taken in
the first 24 hours after intercourse. Effectiveness declines as the interval between intercourse and the start of treatment increases. The major side effect associated with Plan B is nausea.
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
without an advance prescription from a physician or healthcare provider in six U.S. states (Alaska,
California, Hawaii, Maine, New Mexico and Washington).
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
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., a holding company that operates through its principal subsidiaries, Barr
Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture
and marketing of generic and proprietary pharmaceuticals.
This press release contains 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, which typically have lower margins, during any given period; 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 Pharmaceuticals, Inc.