Center for Reproductive Rights: Center Sues FDA for Denying Women Over-the-Counter Access to Emergency Contraception:
FDA Internal Memo Suggests Agency Did Not Follow Regulations
Friday evening, the Center for Reproductive Rights filed suit against the Acting Commissioner of the Food and Drug Administration in federal court for failing to approve the emergency contraceptive product Plan B for over-the-counter status. Emergency contraception (EC), sometimes known as "the morning after pill," reduces the risk of pregnancy by approximately 89 percent when it is taken within 72 hours of unprotected intercourse, according to a study published in Obstetrics and Gynecology.
The Center filed the suit in the U.S. District Court for the Eastern District of New York on behalf of a national organization of reproductive health providers, several individual women activists, and a national organization dedicated to improving Latinas' reproductive health. All of these groups strive to reduce unintended pregnancy rates, including teen pregnancies, by educating women about EC and increasing access to it.
The lawsuit was filed within hours after the FDA announced that it would delay in deciding whether Plan B should be made available over-the-counter to women 16 and older. Last year, the FDA denied another request from Plan B's manufacturers to make the product available over-the-counter to women of all ages. In addition, the FDA has failed to act on a citizen's petition filed by the Center almost four years ago on behalf of numerous health care and reproductive rights organizations.
According to the plaintiffs, by denying women access to Plan B without a prescription, and by failing to follow its own procedures and statutory and regulatory mandates, the FDA violated the Administrative Procedures Act and the U.S. Constitution.
When the FDA denied Plan B over-the-counter (OTC) status last year, it cited a lack of information on whether EC could be taken safely by women under the age of 16 or whether easier access would promote risk-taking sexual behavior among teens. But according to an internal memorandum, the FDA failed to follow proper procedure in making that decision. In the April 2004 memo, the Director of the FDA's Office of New Drugs, Dr. John Jenkins, wrote that "[the FDA] has not heretofore distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women of childbearing potential and I am not aware of any compelling scientific reason for such a distinction in this case." . . .
February 10, 2011 in Contraception, In the Courts, President/Executive Branch | Permalink
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