This story started more than a decade ago. From the time the Food and Drug Administration (FDA) first approved emergency contraception for use, millions of women have used it to avoid an unintended pregnancy. Over that same span, though, countless women suffered a broad range of hardship because a medication proven to be as safe as a common cold reliever was locked behind the pharmacy counter and subject to the possession of government-issued identification, a doctor’s prescription for those under 17, and the drug store’s hours of operation.
This story ends today with a federal judge issuing a momentous decision ordering the FDA to allow emergency contraception to be sold over-the-counter without restriction on where it can be sold or restrictions on age that require identification checks. “More than 12 years have passed since the citizen petition was filed and 8 years since this lawsuit commenced,” the judge wrote. “The F.D.A. has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster.”
This is a long-awaited victory for all women, who will no longer face governmental obstacles to emergency contraception, which is most effective when it is taken within 72 hours of unprotected sex. With this landmark decision, women will be able to get the “morning after” pill on their own terms, without a prescription, when they need it most.
The FDA approved emergency contraception for prescription use in 1999. Two years later, after studies confirmed just how safe emergency contraception is, the Center for Reproductive Rights filed a Citizen Petition on behalf of more than 70 medical and public health organizations to make the medication available without a prescription. And thus began the start of this drawn-out but epic battle.
The politics of President George W. Bush’s administration entered the equation almost immediately. First, the FDA failed to respond to the Center’s petition. Then, the manufacturers of emergency contraception applied for over-the-counter status, and the FDA rejected the application despite agency experts overwhelmingly recommending emergency contraception be sold over the counter without a prescription.
When a drug is recommended by FDA experts, it is almost always approved. After FDA officials denied the morning-after pill over-the-counter status, it became abundantly clear that the FDA was taking cues from the White House rather than following its usual procedures. These actions were unprecedented. The Center soon filed the lawsuit that resulted in today’s decision, suing the FDA for ignoring its own scientific recommendations and treating emergency contraception differently than other pharmaceuticals.
Incremental victories followed:
- In 2006, a New York judge cited a strong showing of “bad faith and improper behavior” by the FDA and cleared the way for the Center to depose high-level agency officials. The depositions revealed White House influence throughout the drug’s review process. As one senior FDA scientist testified, the agency had to reject over-the-counter status for women of all ages in order to appease the “administration’s constituents.”
- Months later, following mounting pressure from the lawsuit and pro-choice lawmakers in Congress, the FDA agreed to make emergency contraception available without a prescription, but only for women 18 and over—leaving the morning-after pill trapped behind the pharmacy counter.
- The Center pushed ahead with its lawsuit arguing that emergency contraception’s safety was undisputed, meriting over-the-counter status. In 2009, the judge ordered the FDA to extend the prescription-free use to those 17 and over and reconsider every single restriction on the medication.
Toward the end of 2011, it appeared that the FDA would, at the very least, grant over-the-counter status to one brand of emergency contraception. Once again, though, politics sabotaged science. Secretary Sebelius overrode the agency’s decision—no secretary had ever done so before—and kept emergency contraception beyond the reach of too many for another 16 months.
Today’s decision is long overdue. Access to safe reliable contraception is an essential part of women’s basic health care. When a woman can plan her pregnancy, she and her family enjoy substantial health, economic, and social benefits.
This 12-year battle has been a top priority for the Center, and would not have been possible without our supporters and all the people who draw the line against government coercion, and politicians and elected officials who stand between a woman and her reproductive health care.
We will continue to work relentlessly so that access to reproductive health care is affordable and open to all.