Media Center: Press Release

“It’s unprecedented to have so many delays when the scientific evidence is so clear. To continue stalling, the FDA ignored 15,000 pages of solid clinical data showing that emergency contraception is entirely safe and highly effective.”

New York, NY—The Food and Drug Administration’s announcement again delaying a decision on over-the-counter status for emergency contraception directly contradicts overwhelming medical and scientific evidence and will contribute to America’s already-alarming rate of unintended pregnancy, Physicians for Reproductive Choice and Health said today.

The FDA has deliberated the issue for years and delayed making a decision several times. Two FDA expert panels overwhelmingly recommended approval of the drug (by a 23 to 4 vote) nearly two years ago. More than 15,000 pages of clinical data from approximately 40 studies were submitted to the FDA with the application to make emergency contraception available over-the-counter (rather than only with a prescription).

The following statement was issued today from Dr. George Thomas, Board Member of Physicians for Reproductive Choice and Health, who testified in support of over-the-counter emergency contraception before the FDA advisory boards in December 2003:

“It’s unprecedented to have so many delays when the scientific evidence is so clear. This appears to be yet another stall tactic that puts politics ahead of science. The FDA is a scientific body, but today’s announcement has nothing to do with science. To continue stalling, the FDA ignored 15,000 pages of solid clinical data showing that emergency contraception is entirely safe and highly effective, and that women need timely access to it. Stalling and delays only lead to more unintended pregnancies.

“Emergency contraception doesn’t end pregnancies—it prevents women from becoming pregnant. In fact, emergency contraception doesn’t have any effect on a fertilized egg that has already implanted. The FDA could have given women one last opportunity to prevent a pregnancy if their contraception fails, if they have unprotected sex or if they are sexually assaulted.

“Giving women timely access to emergency contraception is a public health imperative, and these delays are unconscionable. Based on my own experience with my patients, I know that timely access to emergency contraception would profoundly impact women who don’t want to become pregnant. Physicians for Reproductive Choice and Health and the American College of Obstetricians and Gynecologists estimate that making emergency contraception widely available could prevent at least half of unintended pregnancies in the United States (or about 2 million pregnancies annually) and half of U.S. abortions (or nearly 500,000 abortions per year).”

PHYSICIANS AVAILABLE FOR COMMENT