GAO Report on FDA’S Plan B Decision Process Confirms Center’s Lawsuit

The Government Accountability Office released a report finding that the Food and Drug Administration’s refusal to make the emergency contraceptive, Plan B, available without a prescription was “unusual” and “not typical” of previous decisions on other over-the-counter drugs. On January 21, 2005, the Center for Reproductive Rights filed a lawsuit against the FDA in a New York federal court. The suit was filed on behalf of a national organization of reproductive health providers, several individual women activists, and a national organization dedicated to improving Latinas’ reproductive health. The lawsuit asks that the court order the FDA to make Plan B available without a prescription for women of all ages. Nancy Northup, President of the Center for Reproductive Rights, issued this statement in response to the GAO report.
“The GAO report confirms what our lawsuit has argued all along-the FDA broke its own rules, held Plan B to a higher standard than other over-the-counter drugs, and women have suffered the consequences. We call on the FDA to finally do the right thing and make Plan B available without a prescription to all women.”

LAWSUIT AGAINST THE FDA OVER EMERGENCY CONTRACEPTION DECISION

On January 21, 2005, the Center for Reproductive Rights filed a lawsuit against the Food and Drug Administration’s Acting Commissioner for failing to make the emergency contraceptive product Plan B available without a prescription. The suit was filed in the U.S. District Court for the Eastern District of New York on behalf of the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, and individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy.

Key points of the lawsuit:

• The plaintiffs are asking the court to order the FDA to make Plan B available without a prescription for women of all ages. Increased access to emergency contraception (EC) promotes public health by improving opportunities for women and adolescents to use the drug when they face a crisis. Plan B is only effective for a short time after unprotected sex, and it works most effectively if used within 24 hours of intercourse. Widespread use could prevent as many as half of the 3 million unintended pregnancies in the U.S. each year.


• The FDA is ignoring sound medicine. Decades of scientific research and real-life experience among women of all ages around the world show that Plan B is effective and safe for self-medication. The FDA’s own expert panels have recommended that the pill be switched to over-the-counter status. An internal FDA memo also acknowledges that the clinical data before the agency “clearly support”making Plan B available without a prescription “for all age groups,” and that such approval would be “consistent” with previous decisions on other products.


• The FDA is holding Plan B to a different and higher standard than other over-the-counter drugs. As an internal agency memorandum indicates, the FDA has not previously “distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women,” and there is no “compelling scientific reason” for such a distinction in this case.


• By ignoring scientific fact and holding Plan B to a different standard, the FDA is failing to follow its own procedures and statutory and regulatory mandates. According to the FDA’s own regulations, a drug should be approved for over-the-counter use when it is proven to be effective and safe for self-medication. The FDA’s application of a different standard to granting Plan B over-the-counter status was the result of factors that fall outside of the agency’s statutory mandate.

,