The US Food and Drug Administration has given Teva Pharmaceuticals, the makers of brand name emergency contraception pill Plan B One-Step, exclusive rights to sell their product on store shelves without age restrictions for three years. Generic versions of pill will remain behind the counter and only be available to those 17 years of age or older.
Plan B One-Step costs approximately $50, whereas generic versions cost between $35 and $40. However, with the exclusive rights for Teva, the cost-effective versions will still be denied to young girls or those who do not have government issued identification, creating a barrier for many women and girls. Teva has promised to not increase the price of the drug while it has market exclusivity.
Janet Crepps, senior counsel at the Center for Reproductive Rights, told reporters “The FDA should have left open the option for all generic and potentially more affordable brands of emergency contraception to be made widely available, without delay.”
The FDA cites clinical data Teva submitted in June that showed that Plan B One-Step could be safely taken by young teens as justification for exclusivity. Former FDA assistant commissioner for women’s health, Susan Wood, told the Boston Globe, “The rationale behind exclusivity is that if a company does essential new research to get their product approved over-the-counter, they should get protection from generics for a little bit longer. But the data Teva was asked to collect wasn’t actually essential, and now we’re left in a confusing situation that makes it more expensive for women to get full access to emergency contraception.”
In April, US District Judge Edward Korman ruled that the FDA must make single-pill versions of the morning-after pill available to women and girls of all ages and that it be made over the counter. Korman did not mandate that the restrictions be lifted from the two-pill versions. In June, the Obama Administration announced that itwould not challenge the US Second Circuit Court’s upholding of Korman’s ruling.
Media Resources: Boston Globe 7/24/2013; ThinkProgress 7/23/2013; Feminist Newswire 6/11/2013, 6/5/2013, 4/5/2013