FDA grants Teva exclusive marketing rights for ‘morning after pill’

Teva’s brand of the pill will be the only non-prescription, over-the-counter version of the drug available.

Teva 311 (photo credit: REUTERS/Ronen Zvulun)
Teva 311
(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 drug available.
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.
Having 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 critically important.
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 April approval.
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 of conception.