(photo credit: REUTERS/Ronen Zvulun)
The US Food and Drug Administration on Monday granted Teva Pharmaceuticals
exclusive rights to market their Plan B One-Step contraceptive pill, commonly
known as the “morning-after pill,” for three years.
Teva’s brand of the
pill, which prevents pregnancy if taken within 72 hours of unprotected
intercourse, will be the only non-prescription, over-the-counter version of the
While the availability of the drug over-the-counter
elicited cheers from reproductive-rights groups, the fact that cheaper, generic
alternatives would be barred for several years drew criticism.
previously rejected Teva’s application for approval, the FDA approved the drug
for women over the age of 15 in April. In June, it approved the drug for
over-the-counter sale without restriction.
“Bringing Plan B One-Step out
from behind the pharmacy counter helps women tremendously by removing one of the
biggest barriers to access and timely use of emergency contraception, which is
Plan B One-Step allows women to get what they need
with one dose, without waiting 12 hours to take a second pill to complete the
regimen,” said Jill DeSimone, senior vice president and general manager, Teva
Global Women’s Health.
According to FDA commissioner Margaret A. Hamburg,
research showed that access to emergency contraception could potentially
decrease the rate of unintended pregnancies.
“The data reviewed by the
agency demonstrated that women 15 years of age and older were able to understand
how Plan B One-Step works, how to use it properly and that it does not prevent
the transmission of a sexually transmitted disease,” she said following the
According to Teva, nearly half of all pregnancies in the
US are unplanned.
Of those pregnancies, which number 3.1 million
annually, half of the women report having taken contraception during the month