Emergency Contraception Generics to Remain Behind the Counter, For Now
JULY 19, 2013
The future availability of generic OTC emergency contraception remains uncertain, despite the federal government canceling its appeal on the US District Court decision to make the medication available without age restrictions, according to stories published on June 5, 10, and 11, 2013, on NPR org.
The Justice Department has proposed that the brand-name product Plan B One-Step be the only morning-after pill made available over the counter without age restrictions. According to NPR, Plan B One-Step manufacturer Teva Pharmaceuticals will need to file an FDA application to sell the product over the counter without age restrictions. This would qualify as a new application, and could mean that Teva will be granted a period of marketing exclusivity, during which time generic versions of the drug could not be sold over the counter.
This development does not change the status of single-pill generic forms of Plan B that are currently available behind the counter or older, 2-pill forms of the drug, meaning those products will remain behind the counter and be available by prescription only for those younger than 17 years.
In addition to debates regarding emergency contraception’s OTC availability, at least 1 interest group noted the effect of generic and brand-name price differences on obtaining the pills.
“It has a real impact on giving all women meaningful access to emergency contraception,” Susannah Baruch, interim president and CEO of the Reproductive Health Technologies Project, told NPR. “We know generics tend to be $10 to $20 cheaper than the name brand, and that can make all the difference for many women.”