NOW Calls on FDA to Drop Age Restrictions for Access to EC
By Maddie Burton, Communications Intern
April 15, 2009
On April 22, the FDA issued a press statement that the government will not appeal the court's decision.
After years of campaigning for access to emergency contraception (EC), the first big victory came in 2006, when the Food and Drug Administration (FDA) made EC available without a prescription -- but only to women 18 years and older.
Feminists scored another victory last month when a federal judge returned the issue to the FDA, and partially lifted the age restriction. Based on the unanimous recommendation of the FDA's own professional staff and two expert advisory committees, the court required that the agency extend non-prescription availability to women 17 and above within 30 days.
"We were thrilled about the court's decision, but it didn't go far enough," said NOW President Kim Gandy. "Women of all ages should be able to control their own bodies."
Addressing that concern, the court demanded that the FDA consider striking all age limits from its policy on Plan B (the brand-name under which EC is dispensed in the U.S.).
"The FDA's age restrictions are based on politics, not science. Any and all decisions affecting women's reproductive health care should be dictated by sound science and good medicine," said Gandy. "As the FDA, under new leadership, reconsiders this policy, it must stop playing politics with young women's lives."
The barriers of prescription-only access to EC disproportionately affect young women, who may be reluctant or financially unable to visit a doctor. In addition, Plan B is more effective the sooner it is taken (and is most effective if taken within 24 hours), so it is crucial that young women not be subjected to unnecessary and discriminatory delays.
Following the 2006 designation of Plan B as an "over-the-counter" drug for women 18 and over, the FDA noted that selling EC both with and without a prescription to different age groups at the same time raised "novel" concerns. To accommodate the proof of age requirement, the FDA determined that EC should be kept behind pharmacists' counters, making its "over-the-counter" designation erroneous. This "behind the counter" status also makes EC less accessible to young women who may be embarrassed to ask for it, and puts all women at greater risk of pharmacist refusal. The current policy endangers young women who are at high risk for unplanned pregnancies and presents an obstacle for any woman whose health care might be at the mercy of an ideologically zealous pharmacist.
Refusal or "conscience" clauses permit health providers to deny consumers drugs and procedures that conflict with their personal beliefs. Pharmacists may use these rules to refuse to dispense emergency contraception to women -- even those 18 or older. Placing EC in the reach of women of all ages will empower them to make their own reproductive health decisions, free from any needless interference.
In advance of the FDA's 2006 decision, NOW worked for expanded access to EC, submitting formal comments to FDA reviewers, petitioning Congress, testifying before FDA advisory panels, and generating thousands of emails and phone calls to the FDA commissioner.
NOW cheered the approval of EC as a non-prescription drug, but called strongly for the inclusion of young women in great need of preventing unplanned pregnancies. In light of the recent favorable court ruling, NOW hopes that politics will be set aside in favor of women's reproductive freedom and urges President Obama's new FDA appointees to ensure EC accessibility for all women.
"In order for the FDA to fulfill its responsibility to protect the nation's health, they must ensure EC access to women of all ages and stock it on shelves in front of the counter where patients, not pharmacists, can obtain it," said Gandy.
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