For more than 10 years, emergency contraception has been the “poster child” for what it looks like when politics trumps science, again and again and again. Women’s health advocates, women’s health care providers, and researchers have argued for years (and two different presidential administrations) about the safety of emergency contraception and the importance of its place on the shelf, between the pregnancy tests and the condoms.
The age restrictions on emergency contraception have been in flux. Where do things currently stand?
In 1999, Plan B was approved by the Food and Drug Administration (FDA) as a prescription-only product (all new drugs are first approved as prescription-only). In 2003, the manufacturer of Plan B filed an application with the FDA to make it available over-the-counter (OTC). An FDA Advisory panel voted to recommend Plan B for OTC access with no age restriction. Then political turmoil ensued. You can read all the details here in this handy timeline.
In 2006, Plan B was approved for OTC access, but with an age restriction, which meant men and women 18 years and older could purchase Plan B at the pharmacy, but only with an ID providing proof of age. The Center for Reproductive Rights (CRR) filed a lawsuit against the FDA over the ridiculousness of placing a scientifically unfounded age restriction on emergency contraception, which eventually led to the lowering of the restriction to 17 years. The FDA was also asked to re-review their rationale for imposing an age restriction in the first place.
Then things got worse. Let’s fast forward to 2011.
In 2011, Teva Pharmaceuticals (the manufacturer of Plan B One-Step) filed a new application with the FDA. This application would re-label Plan B One-Step without an age restriction. The application was also accompanied by additional research to prove to the FDA that teenagers could understand the directions for Plan B One-Step and use it correctly. The FDA approved the application, but then the Health and Human Services’ Secretary Kathleen Sebelius uncharacteristically stepped in and overruled the FDA’s decision. Just to clarify how uncharacteristic this action was, according to the New York Times, “although Ms. Sebelius had the legal authority to overrule the F.D.A., no health secretary had ever publicly done so.”
After the shock and outrage among women’s health advocates, some government officials, and, of course, women’s health care providers, there was the realization that 2012 was an election year. There was no way the Administration was going to change its stance in 2012 (plus we were celebrating no-copay birth control!), so instead, CRR reopened their lawsuit against the FDA for imposing unnecessary age restrictions on emergency contraception on February 8, 2012. In addition, CRR asked for HHS Secretary Sebelius to be added as a defendant for her role in overruling the FDA.
More than a year later, things were starting to look up. On April 5, 2013, U.S. District Court Judge Edward Korman ordered the FDA to lift the longstanding age restrictions that impeded and delayed a woman’s access to emergency contraception. Not to mention Judge Korman had some choice words to describe the actions of the government: “arbitrary,” “capricious,” and “unreasonable.”
Just three weeks later things got a little confusing. On April 30, 2013, the FDA approved an amended application from Teva. This amended application sought to re-labeled Plan B One-Step, with a new age restriction, 15 years, and a point of sale restriction that would place it on the shelves, but still require an ID upon check out.
Coincidentally, shortly after, the Department of Justice appealed the April 5 decision of the U.S. District Court Judge Edward Korman. In short, the Administration was not ready to accept the availability of emergency contraception OTC without an age restriction …
That is, until June 10, when the Administration decided not to continue with its appeal. And that’s how we arrived to where we are today.
As of June 13, only Plan B One-Step is set to be approved for over-the-counter sales without an age restriction. Of course, the FDA will have to re-approve the application from Teva, which means you shouldn’t expect to see Plan B One-Step on the shelf at your local store anytime too soon.
For the time being, Planned Parenthood Arizona health centers will continue to be a place where you can come and purchase emergency contraception. At this time, you can purchase NextChoice (the generic version of Plan B) at any Planned Parenthood Arizona health center for $45 with valid ID showing proof of age (17 years or older) or after a brief consultation with a clinician if you are under 17 years of age.