MEDICATIONS: MEDICAL GROUPS SET THE RECORD STRAIGHT ON EMERGENCY CONTRACEPTION

May 6, 2004 — Two major medical groups today urged the FDA not to succumb to political pressure on emergency contraception (EC), stating "politics should not trump medical evidence for making Plan B® available over-the-counter."

Speaking from The American College of Obstetricians and Gynecologists' (ACOG) Annual Clinical Meeting, representatives from ACOG and Physicians for Reproductive Choice and Health (PRCH) strongly objected to the Food and Drug Administration's (FDA) announcement to delay its decision to grant over-the-counter (OTC) status to an emergency contraceptive pill (ECP) known as Plan B. In December, two FDA expert advisory panels overwhelmingly recommended approval of the drug by a 23-to-4 vote. The agency typically follows the assessment of the scientific committees.

"We're here today to set the record straight — EC does not increase promiscuity among teenaged women, nor does it cause women to abandon their regular birth control methods," said Vivian M. Dickerson, M.D., ACOG president elect and an associate professor at the University of California Irvine (UCI) and director of the division of general ob-gyn at the UCI Medical Center. In response to political opponents' criticisms of emergency contraception, she said, "I feel somewhat like a broken record. These issues were considered and largely rejected by the FDA's expert advisory panels that concluded that over-the-counter status would not encourage young people to have unprotected sex."

ACOG and PRCH say Plan B meets all the FDA criteria for OTC status. More than 15,000 pages of clinical data from approximately 40 studies were submitted with its application. Studies presented at the December FDA hearing also showed evidence that women will not overuse or abuse EC, another issue raised by opponents of the switch to OTC status.

"I am stunned that an evidence-based agency like the FDA can ignore the overwhelming scientific data and advice of their own committees regarding the safety and efficacy of having emergency contraception available OTC," noted Harry S. Jonas, M.D., a member of the PRCH Board of Directors and a past president of ACOG. "When political expediency prevails over sound scientific information, women have once again become marginalized in their ability to make critical decisions," added Dr. Jonas, who is also a special consultant to the dean of the University of Missouri-Kansas City School of Medicine.

"Barriers to this safe, effective medicine hurt women's health. The current FDA delay is indirectly causing more unintended pregnancies, with their associated morbidity, mortality and expense. Ironically, by failing to act promptly on the advisory committee recommendation for OTC status, the FDA is now impairing rather than promoting women's health," said David A. Grimes, M.D., a clinical professor in the department of ob-gyn at the University of North Carolina at Chapel Hill School of Medicine and vice president of biomedical affairs for Family Health International.

Emergency contraceptive pills, which are specific combinations of birth control pills in higher doses, act to prevent pregnancy. Unlike early medical abortion, if a woman is already pregnant, EC will not terminate her pregnancy.

Emergency contraception can prevent pregnancy in several ways. It may prevent ovulation, fertilization or implantation of the egg in the uterus. All are necessary stages for pregnancy to occur. Emergency contraception is highly effective in preventing unintended pregnancy. Access and speed are important if ECPs are to be effective. If taken within 72 hours of unprotected sexual intercourse, ECPs prevent 89 percent of pregnancies. Efficacy is greatest, however, if used within 24 hours.

ACOG and PRCH estimate that making EC widely available over-the-counter has the potential to 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).

Women currently need a physician's prescription to obtain EC except in a small number of states (AK, CA, HI, ME, NM and WA). Studies show that women have difficulty gaining access to both physicians and pharmacies for prescribed EC within the needed window of time for it to work. "Thousands of women are in need of emergency contraception every day, particularly over weekends," said Wendy Chavkin, M.D., M.P.H., a founding member and current chair of the Board of Directors of PRCH. She is a professor of clinical public health and ob-gyn at the Columbia University Mailman School of Public Health and College of Physicians and Surgeons.

"It is quite a shock and a disappointment that the FDA is making decisions in response to political pressure rather than to scientific evidence and concern for the public health. Emergency contraception could significantly reduce the troubling rates of unintended pregnancy in the United States," added Dr. Chavkin. Both ACOG and PRCH recommend that physicians provide advance prescriptions to improve patient access to this care.

"There is a public health imperative in this country to increase access to EC. More choice for women equals a reduction in unintended pregnancies and fewer abortions. That is an argument even opponents of abortion cannot debate," Dr. Dickerson noted.