FDA Internal Memo Suggests Agency Did Not Follow Regulations
Read the complaint online (PDF) | Virtual Press Kit
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.”
He further wrote that “the available data clearly support a conclusion that Plan B meets the statutory and regulatory requirements for availability without a prescription for all age groups. Such a conclusion is consistent with how the Agency has made determinations for other OTC products, including other forms of contraception available without a prescription.”
Following the FDA’s rejection, the makers of Plan B submitted a modified application seeking over-the-counter access for their product for women over the age of 16. The FDA’s announcement this evening was in response to that application.
“There are about three million unintended pregnancies in the U.S. each year. By denying women over-the-counter access to a safe and effective drug that would significantly reduce those numbers-including pregnancies that end in abortion-the FDA is acting unlawfully and ignoring its mandate to advance the public health,” said Nancy Northup, President of the Center for Reproductive Rights.
According to the Alan Guttmacher Institute, a nonpartisan research organization, EC has the potential to prevent as many as half the unplanned pregnancies in the U.S., including the 700,000 that now end in abortion. In addition, studies published by the Journal of the American Medical Association and Journal of Pediatric and Adolescent Gynecology found that easy access to EC does not lead to an increase in unprotected sex or risk-taking behavior in women or teens. The JAMA study also found that EC can be safely and properly used without a prescription.
“The FDA is ignoring the medical and scientific facts. Emergency contraception meets all the criteria for over-the-counter availability for women of all ages. There’s no danger of overdosing or addiction, and it’s simple to use. Not only is it safe for women and adolescents, it improves their lives and health because it prevents unintended pregnancies,” said Simon Heller, the Center for Reproductive Rights attorney representing the plaintiffs.
The plaintiffs in the case are the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, and individuals from a grassroots advocacy group, the MAP Conspiracy.
Learn more about EC at www.backupyourbirthcontrol.org