National Partnership for Women & Families

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Market Exclusivity, Confusion Hinder Emergency Contraceptive Access

Market Exclusivity, Confusion Hinder Emergency Contraceptive Access

August 23, 2013 — Teva Pharmaceuticals began selling its emergency contraceptive Plan B One-Step over the counter on Aug. 1, but a number of obstacles remain for women hoping to obtain the drug or other EC products that still are kept behind the counter, the Orange County Register reports (Hall, Orange County Register, 8/21).

Although U.S. District Judge Edward Korman in April ruled that restrictions should be lifted on all EC drugs, in June he approved FDA's proposed plan of compliance to allow OTC sales of only Plan B One-Step. FDA in July granted Teva Pharmaceuticals market exclusivity through 2016. Other manufacturers can obtain FDA approval to sell EC without a prescription, but only women who can verify with ID that they are ages 17 and older can buy those versions (Women's Health Policy Report, 7/24).

According to the Register, several factors hinder access to Plan B One-Step. For example, products with older packaging -- manufactured prior to the latest approval change -- still must be kept behind the counter and made available only to individuals ages 17 and older. In addition, many stores are packaging the new Plan B One-Step boxes in plastic "clamshell" containers, reportedly to prevent theft, which could make consumers feel self-conscious about asking a store clerk to open the case.

Meanwhile, two other EC products are available, but they are subject to age restrictions and kept behind the counter until Teva's market exclusivity period expires, the Register reports. The $50 cost of Plan B One-Step also can be a barrier.

Delays Questioned

Jessica Arons -- president and CEO of the Reproductive Health Technologies Project -- said, "There's definitely a lot of confusion, both among consumers and retailers," especially because of the drug's "arduous" approval process. However, she said it is unclear "to us why there might be any hesitation to put [Plan B One-Step] on the shelves and make it ready for people when they need it," especially considering that pharmacies have had time to learn the rules and stock the drug.

RHTP has created the ETOTC Tumblr for the public to access EC-related information, including pharmacies that have it available and updates on Oklahoma's ongoing legal fight over EC restrictions (Orange County Register, 8/21).