On Monday night, Teva Pharmaceuticals received exclusive rights from the U.S. Food and Drug Administration (FDA) to sell the emergency contraception pill Plan B One-Step over the counter and without age restrictions until April 2016. A cheaper generic version will also be available—but only with a prescription and to women 17 years or older.
This may be a win for Teva, but it isn’t for women’s healthcare. At about $50 for a one-pill dose, Plan B is a significantly pricier option than generic versions selling for $10 or $15 less.
Says Jessica Arons, president and CEO of Reproductive Health Technologies Project,
We are disappointed by [the] FDA’s most recent decision to maintain age restrictions on generic brands of emergency contraception, which will leave more affordable alternatives of safe and simple emergency products out of reach for many women.
Erica Jefferson of the FDA said that Teva received market exclusivity since the pharmaceutical giant had completed clinical research that deemed Plan B One-Step use safe for girls younger than 17. The Los Angeles Times reports that, by federal law, the FDA is permitted to “grant such exclusive agreements to drug firms that fund and conduct clinical trials that are deemed essential to the drug’s approval.”
But Susan Wood, a former FDA assistant commissioner of women’s health who resigned in 2005 because the FDA was blocking over-the-counter status for emergency contraception, points to what U.S. District Judge Edward Korman called a “sweetheart arrangement” between the FDA and Teva as the leading motive behind the move to grant exclusivity:
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.
The years-long effort to gain over-the-counter access to emergency contraception went on quite the rollercoaster ride over the past few months. The Obama administration attempted to enforce age restrictions on over-the-counter sales, but on June 10 it finally announced it would comply with U.S. District Judge Edward Korman’s ruling, making the drug available over-the-counter to women of all ages. In the weeks following, the FDA formally approved Plan B One-Step for over-the-counter use while lifting age restrictions.
Emergency contraception has only just begun to line the aisles of pharmacies around the country, making the resurgence of age restrictions on the generic, more-affordable version of Plan B all the more concerning.
Photo from Flickr user Irina Ivanova under Creative Commons 2.0