FDA Approval of Over-the-Counter Emergency Contraception Uncertain
Barr Laboratories, distributors of the emergency contraceptive Plan B, are reportedly concerned that the Food and Drug Administration (FDA) will not approve their proposal to make the drug available without a prescription. Carole Ben-Maimon, president of Barr Laboratories' research division, told the Washington Post that she thinks “an approval is not a likely scenario." An overwhelming majority of expert FDA advisory panel members agreed in a December meeting that emergency contraception (EC) is safe, effective and meets all the requirements for over-the-counter status.
The medical community and women’s rights and health advocates accuse the FDA of succumbing to a vocal minority of right-wing political pressure and disregarding science in their decision to postpone the final ruling until May 21. In a statement issued yesterday, the American College of Obstetricians and Gynecologists (ACOG) and Physicians for Reproductive Choice and Health urged that “politics should not trump medical evidence for making Plan B available over-the-counter.”
Feminist Majority Foundation Medical Director Beth Jordan, MD concurred: “This decision should be made on scientific merit, not politics. The safety and efficacy of EC has never been in question and to deny women unrestricted over-the-counter access is simply unacceptable from a public health standpoint.”
EC is up to 95 percent effective in preventing pregnancy if taken within 24 hours after unprotected sex, failed contraception, or rape. It is safer than aspirin, meets all of the FDA's requirements for over the counter status, and has the potential to prevent 800,000 abortions in the United States annually.
“The voices of a vocal majority make an enormous difference,” says Dr. Jordan. “Join the majority of Americans who support over-the-counter access to EC and immediately urge the FDA to follow the advice of its own expert advisory panel, stop playing politics with women’s lives, and make emergency contraception available over the counter.”