Center for Reproductive Rights Fighting the Good Fight on Emergency Contraception

In the wake of last week’s decision on Plan B One-Step, you may be wondering how an administration can be taken to task when it does something so extreme. Over 5,000 people already have joined our letter telling the President and Secretary Sebelius that science should speak for itself. And then, there’s legal action. On Tuesday, the Center for Reproductive Rights (CRR) announced that it is reopening its 2005 lawsuit against the FDA to make emergency contraception available over the counter to all women. CRR also announced that it would add Secretary Sebelius as a defendant. If the Administration still doesn’t come to its senses after hearing from thousands of Americans, an order from a judge could change things.

So what is this lawsuit all about? Before there was Plan B One-Step, the one-pill form of emergency contraception, there was the original Plan B, which requires taking two pills over a twelve hour period (and remains on the market today, but behind the counter). In 2001, CRR filed a Citizen Petition to make Plan B available without a prescription to all women regardless of their age. In 2003, Plan B’s manufacturer applied to have the medication available without a prescription, but the application was denied in 2004. Plan B’s manufacturer submitted a revised application, but the FDA failed to meet its own deadline to review that application in January 2005.

At that point, the FDA hadn’t acted on CRR’s Citizen’s Petition either, so CRR filed a lawsuit claiming that the FDA treated Plan B differently than other drugs. Through depositions of high-level FDA officials, CRR gathered evidence that the FDA’s consideration of Plan B had been subject to improper political influence. While the lawsuit was still pending in 2006, the FDA approved nonprescription access for women 18 and over (requiring a prescription for those younger than 18), but women still had to obtain Plan B from a pharmacist. In 2007, CRR filed for summary judgment in the case.

In 2009, U.S. District Court Judge Edward Korman ruled that the FDA had “acted in bad faith and in response to political pressure” and the FDA’s justification for the 18-and-up restriction “lacks all credibility” and was based on “fanciful and wholly unsubstantiated ‘enforcement’ concerns.” The court ordered the FDA to extend over the counter access to 17 year olds within 30 days, which it did, and to reconsider the original Citizen’s Petition. As of November of last year the FDA had taken no action on the Citizen’s Petition, so CRR filed a motion to hold the agency in contempt of court for failing to follow the order. CRR and the FDA were scheduled to be in court this past Tuesday on the motion. Quite literally at the eleventh hour, on Monday night the FDA denied CRR’s Citizen Petition on the grounds that it needed more data on use and label comprehension studies. Because the FDA acted on the petition, Judge Korman denied CRR’s motion for contempt; however, he didn’t stop there. According to CRR, Judge Korman “repeatedly noted the similarities” between the FDA’s actions from last week and their prior actions involving emergency contraception.

As CRR’s lawsuit has already shown, these cases can take a great deal of time. For women who have difficulty accessing emergency contraception while this case is pending, the lawsuit probably isn’t much comfort. But CRR is fighting the good fight for women of all ages on this one. It ain’t over ‘til it’s over.