After carefully considering her situation and making a personal decision, a young woman heads to her local pharmacy. Unfortunately for this young woman, politics and an unwarranted age restriction have followed her to the counter and will deny her access to the emergency contraceptive she needs.
After several years of delays and a series of questionable actions by top Food and Drug Administration (FDA) officials, Plan B® emergency contraception was first granted over-the-counter status for women 18 and older by the FDA on August 18, 2006. The unnecessary age restriction placed on Plan B was particularly surprising – with more than forty studies confirming emergency contraception as safe and effective and the FDA’s own advisory panel, a group of scientists and medical professionals, voting 23-4 in favor of switching emergency contraception to over-the-counter status without an age restriction. Scientific integrity at the FDA took a backseat to a conservative political agenda.
In March 2009, a US District Court ruled on the unprecedented actions by the FDA in relation to Plan B’s over-the-counter age restriction. In US District Judge Korman’s decision, he concluded that the FDA sacrificed “reasoned agency decision-making” and “departed in significant ways from…normal procedures” under pressure from the Bush Administration – an administration that placed politics ahead of science and women’s health. As a result of this ruling, the FDA was directed to lower the over-the-counter age restriction on Plan B from 18 to 17 years of age and re-review existing scientific evidence to decide whether an age restriction is even necessary.
Although the age restriction on over-the-counter emergency contraception has been lowered from 18 to 17 years of age, the FDA has failed to actively re-review existing scientific evidence and make a decision on the need for an age restriction. One and half years later, America’s women are still waiting – but we are not waiting silently. On November 16th, the Center for Reproductive Rights filed a motion for contempt of court against the FDA for failing to proceed in a timely manner. On behalf of Annie Tummino, CRR is requesting that the “Court find the FDA in contempt, direct the FDA to issue a decision on the Citizen Petition within forty-five days of the contempt finding, and order any other relief that the Court deems fair and appropriate.”
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As women’s health advocates we cannot accept the inaction of the FDA. It is unfair and unacceptable that the FDA has ignored the court’s order and it is unfortunate that a government agency responsible for protecting the public health is failing American’s young women. It is unreasonable that we have to go back to court just to get the FDA to follow its own process for over-the-counter approval, especially when there is no medical or scientific rationale for an age restriction on emergency contraception. In order to show the FDA the extensive commitment and interest of women’s health groups, the Center for Reproductive Rights has created an action alert for advocates to circulate and support.
Although there are many birth control options to choose from, a woman might forget to take her pill, a condom might be put on incorrectly, sex might not be planned for or even wanted. These incidences can happen to any woman of any age. Women, regardless of age, should not be denied an important and time sensitive contraception option.
For the sake of women’s health and for the sake of scientific integrity, the FDA must act now and reconsider its age restrictions on emergency contraception.