[Apr 22, 2003]
Women's Capital Corp., maker of the emergency contraceptive Plan B, yesterday applied to the FDA for permission to sell the pills without a prescription, the New York Times reports (Zernicke, New York Times, 4/22). If taken within 72 hours of unprotected sexual intercourse, EC can reduce the risk of pregnancy by 89%, according to the Los Angeles Times (Roan, Los Angeles Times, 4/21). Sharon Camp, CEO of WCC, said that over-the-counter status would increase accessibility to Plan B and help reduce unplanned pregnancies, according to the Washington Post. "Studies have shown that there are 37 million contraceptive accidents [in the United States] each year -- where a condom breaks or a woman forgets to take her pill and she has unprotected sex," Camp said, adding, "If these women had an emergency contraceptive, then we could reduce unintended pregnancies by half and abortions by half" (Kaufman, Washington Post, 4/21). Plan B is thought to work by interrupting ovulation, preventing fertilization of an egg or inhibiting a fertilized egg from implanting in the uterus. Although the regimen is different from the medical abortion pill mifepristone, some antiabortion groups oppose the sale of EC, according to the Los Angeles Times. "It works as an abortifacient, meaning it can take the life of a pre-born child," Judie Brown, president of the Virginia-based American Life League, said, adding, "It poses risks to the woman taking it. There have been no studies whatsoever on the long-term effects of this pill regimen, especially the effect on teenagers" (Los Angeles Times, 4/21). Kirsten Moore, president of the Reproductive Health Technologies Project, said that the organization is "hopeful that the FDA review process will help educate more women about emergency contraception," citing statistics from their surveys that show that 60% of U.S. voters are unaware that EC exists and has been proven effective in preventing pregnancy after unprotected sex (Reproductive Health Technologies release, 4/21). The Senate this year rejected a proposal for a national EC awareness campaign (Los Angeles Times, 4/21). WCC, which is a small firm that relies on foundation support and venture capital funding, has little money for advertising that could raise Plan B's profile. Camp said that she hopes a larger pharmaceutical company will buy the rights to Plan B and start a major marketing campaign if the contraceptive is approved for over-the-counter sale, according to the Post.
EC Availability
Since the FDA in 1999 approved Plan B to be sold on a prescription basis, approximately three million doses have been sold, Camp said, according to the Post. EC is available without a prescription in California, Washington and several other states, but a pharmacist must counsel women before they receive the regimen, which remains a "behind-the-counter" drug. The FDA has indicated that it will make its decision on whether to approve the over-the-counter request in about 10 months. Camp said that Plan B's cost would remain around $27 if approved for nonprescription use, but she added that the regimen is sometimes available for less at family planning and other public health clinics (Washington Post, 4/21). According to the Times, many health insurance plans cover the cost of Plan B prescriptions, but most women still have to pay for a doctor's office visit and any prescription copayment (Los Angeles Times, 4/21).
For current women's health policy news, visit the National Partnership for Women & Families' website.