RH Reality Check: Let Down Again: Obama’s FDA Inexplicably Fails to Advance New Emergency Contraception Rules

The first year of the Obama presidency is increasingly feeling like one of those maddening romantic relationships for many pro-choice supporters — brimming with promise in the beginning, but during the actual courtship, rife with disappointments. This week is perhaps the most heartbreaking. It almost goes without saying that the president’s decision to cut a deal with anti-choice Democrats in the healthcare debate this past weekend and sign an executive order reiterating current law banning federal funding for abortion left many of us reeling. But this week also marks the one-year anniversary of a court ruling on emergency contraception that remains unenforced, and is a reminder of yet another key failing in reproductive health on the part of the Obama administration. In March 2009, a federal judge delivered a blistering opinion to the Food and Drug Administration, condemning the agency’s Bush-era political appointees for ignoring the scientific evidence and restricting access to emergency contraception, a critical tool in preventing unwanted pregnancies and addressing the consequences of rape. In its decision, the court ordered FDA to reconsider limits on access to emergency contraception. Yet no progress has apparently been made over the past year to remove the senseless and unjustified age limits, or to relocate emergency contraception where it belongs – out from behind pharmacy counters and next to the condoms and contraceptive jelly in a regular aisle. Today, emergency contraception, also called the “morning after pill” and available under the trade names Plan B, One-Step, and Next Choice is available without a prescription, but only for women age 17 and older. Pharmacies and clinics must keep it behind the counter and anyone seeking to buy it must show government issued identification proving their age in order to buy it without a prescription. Needless to say, these heavy-handed restrictions, unprecedented for drugs with over-the-counter status (OTC), make it harder and more stigmatizing for consumers to get the contraception during its most effective window. They also lack a scientific basis: Plan B has no known serious side effects or serious long-term health effects and scientists and medical experts agree that there are no medical grounds for denying women access to emergency contraception. After Plan B became available by prescription in 1999, we filed a Citizen’s Petition in 2001 on behalf of over 70 medical and public health organizations requesting that the FDA make emergency contraception available over the counter. The manufacturer of the drug also applied for OTC status in 2003. That same year, after reviewing the scientific evidence, the FDA’s expert Advisory Committee unanimously agreed that Plan B was safe for non-prescription settings, and voted 23 to four in favor of the switch to OTC status without any age or point-of-sale restrictions. Despite this clear conclusion, for the first time in 10 years, the FDA did not follow the recommendation of its Advisory Committee and denied the manufacturer’s application in 2004. Moreover, it delayed action on the Citizen’s Petition for years — long after it was required by law to respond. The Center for Reproductive Rights challenged this delay and the unprecedented restrictions in court.  After years of litigation and pressure from the court, the FDA finally allowed OTC status for women 18 years of age and over. This change was only a small breakthrough. In addition to the needless age distinction for OTC status, the FDA continued to impose the intrusive point-of-sale restrictions for non-prescription access that remain in place today. Our lawsuit demonstrated that the FDA’s decision to over-rule its scientists departed sharply from agency precedent and was the result of political influence from the Bush White House, and the federal judge hearing the case agreed. According to Judge Korman: “FDA upper management, including the Commissioner, wrested control over decision-making on Plan B from staff that normally would issue the final decision on an over-the-counter switch application, … and the Commissioner — at the behest of political actors — decided to deny non-prescription access to women 16 and younger before FDA scientific review staff had completed their reviews.” In short, FDA upper management politicized a decision that impacts the health and safety of women, and got caught red-handed. Judge Korman ordered the FDA to permit Plan B to be made available to 17-year-olds without a prescription immediately and to reconsider all of the remaining restrictions. Since the decision, the FDA has made EC available without a prescription to women 17 and older, an important but limited gain. But 12 months and multiple requests for information later, the FDA remains silent regarding its other unprecedented and unwarranted restrictions. A core promise of the Obama administration was to restore the scientific integrity of federal agencies and to act quickly to remedy the obvious and lamentable politicization of agency decision-making by the prior administration. The FDA’s continued inaction on this simple issue is therefore deeply disappointing. The agency already has sufficient scientific evidence on which it could base a reasoned decision to rescind the restrictions. We expect the FDA to safeguard our nation’s health by making decisions based on sound, well-documented science, not political or ideological imperatives. A federal court ruling has already demanded action — and public health demands quick action as well. The FDA should stop dragging its heels and make emergency contraception available over the counter to all women without restriction. With backtracking on abortion now encoded in the law, access to emergency contraception looks now more important than ever.

Blog originally posted at RH Reality Check.