FDA decision on Plan B OTC status delayed
Senators unsatisfied with continued delays on approval of over-the-counter status of Plan B
Friday January 21, 6:01 pm ET WOODCLIFF LAKE, N.J.
PRNewswire-FirstCall
Barr Pharmaceuticals, Inc. today confirmed that the U.S. Food and
Drug Administration (FDA) has informed the Company that it is unable
to complete its review of the Company’s Supplemental New Drug Application
(sNDA) to market the Plan B® (levonorgestrel) emergency contraceptive
Over-The-Counter (OTC) by the January 21st Prescription Drug User
Fee Act (PDUFA) date. The FDA also indicated to the Company that it
is committed to completing its review of the application in the near
future. The Company remains optimistic that the agency will approve
Plan B for OTC sale. Plan B continues to be available to American
consumers by prescription.
The Company’s sNDA, if approved, would permit the OTC sale of Plan
B without a prescription for women 16 years of age and older. It would
maintain the prescription status for women age 15 years of age and
younger.
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 101 countries, 33
of which do not require a prescription. Emergency contraception is
currently available in some pharmacies without an advance prescription
from a physician or healthcare provider in six U.S. states (Alaska,
California, Hawaii, Maine, New Mexico and Washington).
Plan B was approved by the FDA in 1999 as a safe and effective prescription
only emergency contraceptive for women. Plan B is the first progestin-only
emergency contraceptive. The application seeking over-the- counter
status for Plan B was filed with FDA in 2003. In May 2004 the FDA
issued a Not Approvable Letter offering Barr the option of seeking
dual status that would make the product available over-the-counter
for women 16 years of age and older, and by prescription only for
women under the age 15.
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. and its subsidiaries are engaged in the
development, manufacture and marketing of generic and proprietary
pharmaceuticals.