Yesterday, FDA announced that it has approved Teva Women’s Health, Inc.’s application to market its Plan B One-Step emergency contraceptive for women ages 15 and up. The press release notes that this application was pending before a federal judge ordered the agency to make Plan B available without any age restrictions; the 15-and-up change is “independent of that litigation and this decision is not intended to address the judge’s ruling.”
(A quick refresher: In December 2011, HHS Secretary Kathleen Sebelius overruled FDA Commissioner Margaret Hamburg’s decision that Plan B should be available over the counter without age restrictions; instead, Secretary Sebelius lowered the age at which a woman can obtain Plan B from a pharmacist without a prescription from 18 to 17. Last month, a federal judge overturned the age restriction.)
Anything that improves women’s access to effective forms of contraception is a step in the right direction. And yesterday’s FDA announcement isn’t an improvement just because it extends emergency contraceptive access to 15- and 16-year-olds (although that’s certainly worthwhile); it also reduces the barriers women of any age face when trying to obtain Plan B quickly. Given that the drug’s effectiveness depends on being taken promptly after unprotected intercourse, speed matters. Up until now, Plan B has only been available from a pharmacist, who must then verify the purchaser’s age with an ID. Pharmacy hours tend to be limited, and when my colleague Susan Wood tried to purchase Plan B following the 2011 decision, she had to visit three stores to find an open pharmacy counter, then stand in two different lines in order to show her ID and make the purchase. Now, FDA announces that the product will be available in retailers’ family planning sections and during hours when these stores’ pharmacies are closed, and cashiers can check IDs:
The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.
In addition, Teva will make the product available in retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.
For women ages 15 and up who have government-issued IDs, access to emergency contraception is getting easier. Now, we just need to wait and see how HHS responds to last month’s court decision: will it appeal, or will it eliminate all age restrictions on emergency contraception?
Update, 5/2: At about the same time I was writing this post, HHS was announcing it will appeal the federal court decision.