FDA Rejects Over-the-Counter Sale of Emergency Contraception

On May 7, the Food and Drug Administration (FDA) rejected an application by Barr Pharmaceuticals to sell its Plan B emergency contraception without a prescription. The FDA’s acting director, Steven Galson, overruled two expert advisory panels and his own staff when making the decision, which shocked and dismayed reproductive-rights advocates across the country.

In a rejection letter to Barr, the agency cited concerns that Plan B would be misused by young women. In a letter to Barr, the agency asked for further proof that sale of the medication would not be harmful to adolescents or for a revised application that would prevent distribution to women under the age of seventeen.

Critics of the FDA's decision charged that Galson made a calculation based on politics over science. The American College of Obstetricians and Gynecologists, for example, issued a statement calling the decision "morally repugnant," a "tragedy for American women, and a dark stain" on the FDA's reputation.

History of Emergency Contraception and OSI’s Involvement

In 1997, the FDA declared emergency contraception—the "morning after” pill—to be safe and effective in safely preventing pregnancy for 72 hours after unprotected sexual intercourse. At that time, OSI's new Program on Reproductive Health and Rights became a major funding force in moving emergency contraception into mainstream medicine and in helping to bring the dedicated product, Plan B, to market.

OSI has provided a substantial portion of the approximately $30 million that has been spent on this effort sine 1997, joining the David and Lucile Packard Foundation and other smaller funders on grants to educate the public, train medical providers, and eliminate barriers to wider access for emergency contraception by petitioning for state level action and FDA approval to sell the drug directly through pharmacies, without a prescription. Through a program-related investment, OSI also became a principal and active participant in the Women's Capital Corporation, the innovative company that created Plan B and recently sold it to Barr Pharmaceuticals.

The May/June 2001 issue of Ideas for an Open Society, OSI's occasional paper series, focused on reproductive health and rights. In a feature article titled "The Abortion Debate: Finding Common Ground," Ellen Chesler, director of the Program on Reproductive Health and Rights, discussed the importance of emergency contraception, RU-486, and the need to lift restrictive legal provisions that govern surgical abortions.

OSI Grantees

The following are among the grantees that have received support from OSI for their work on emergency contraception and other reproductive-health issues:

Go2ec.org
NARAL Pro-Choice America
Planned Parenthood Federation of America
Reproductive Health Technologies Project