FDA's Nonprescription Plan B Approval Unlikely To Cause Much Change In Public Health, Some Experts Say

FDA's approval on Thursday of an application to allow nonprescription sales of Barr Laboratories' emergency contraceptive Plan B to women ages 18 and older likely will not have a major impact on the number of unintended pregnancies and abortions, some reproductive health experts said Friday, the AP/Forbes reports (Bridges, AP/Forbes, 8/25). Plan B can prevent pregnancy if taken up to 72 hours after sexual intercourse. The approval of Barr's application requires the company to "[m]onitor the effectiveness of the age restriction and the safe distribution of [nonprescription] Plan B to consumers [ages] 18 and above and prescription Plan B to women under [age] 18." Barr has agreed to send "anonymous shoppers" into pharmacies to test compliance with the age restriction, to distribute with the drug a booklet about its proper use, and to exclude gas stations and convenience stores from selling the drug. Barr spokesperson Carol Cox said the cost of the prescription form of Plan B to girls ages 17 and younger, which is about $25 to $40, likely will increase because of higher distribution and packaging costs, adding that the drug should be available for nonprescription sales this fall (Kaiser Daily Women's Health Policy Report, 8/25).

Potential Impact of Approval
According to Guttmacher Institute estimates, EC in 2000 prevented more than 100,000 pregnancies, about half of which likely would have ended in abortion. There are about 3.1 million unintended pregnancies in the U.S. annually, and about half occur among women who do not use contraception, according to the AP/Forbes. Barr distributes about 1.5 million packets of Plan B annually, Cox said. "If you look at the number of acts of unprotected intercourse on one hand, and the use of Plan B on the other, it's like a cork on the ocean," James Trussell, director of the Office of Population Research at Princeton University, said. He added that the effect of FDA's approval of Barr's application will not be "zero, but it will be hard to measure because it will be so small." The amount of people using Plan B also is likely to increase, though "not to dramatic effect," the AP/Forbes reports. According to a study published in January 2005, women who did not have to get EC through a pharmacist or physician increased their use of EC but did not significantly decrease their rate of unplanned pregnancy. The results of the study suggest that removing the barriers to EC access might not affect pregnancy rates, according to the AP/Forbes. Women who do not use a birth control method account for about half of all unintended pregnancies, but it is not clear if these women will use Plan B after unprotected sex, the AP/Forbes reports (AP/Forbes, 8/25). In addition, Yoly Coloado, a nurse at the Walton Family Practice in New York City, said that Medicaid likely will not cover the cost of Plan B for women who can buy it without a prescription and that the cost of the drug might prevent some poor women from buying it (Vasquez/Hammer, New York Times, 8/26). Medicaid currently covers Plan B and requires beneficiaries to contribute a small copayment for the prescription version of the pill, but the system likely will change because of the application's approval. Some advocacy groups are working on programs that would assist women enrolled in Medicaid to pay for Plan B if Medicaid discontinues coverage (Kaiser Daily Women's Health Policy Report, 8/25).

Access Changes
New York City will boost efforts to communicate with pharmacists and physicians about educating the public about EC, Deborah Kaplan, assistant commissioner of the city's Bureau of Maternal, Infant and Reproductive Health, said, adding that the FDA approval will "strengthen our ability to make [EC] available" (Taylor, Long Island Newsday, 8/26). Pharmacy chains CVS and Walgreen have said they plan to begin selling Plan B without a prescription, and Wal-Mart spokesperson Kevin Gardner last week said the company has not yet decided whether it will sell Plan B without a prescription (Kaiser Daily Women's Health Policy Report, 8/25). The pharmacy chain Duane Reade's policy says that individual pharmacists "can step away" from selling certain drugs but that customers "will always have access" to medications they seek, the New York Post reports (Andrew/Wolff, New York Post, 8/27). Funding, staffing and religious issues have precluded many colleges from distributing EC, and policies on campuses that offer the pills likely will not change as result of FDA's approval, Christine Peterson, director of gynecology at the University of Virginia department of student health, said, the AP/Forbes reports. Female UVA students currently can call in for EC prescriptions at any hour, Peterson said (AP/Forbes, 8/25).














WAMU's "The Diane Rehm Show," a nationally syndicated NPR program, on Monday in the second hour of the show is scheduled to include a discussion of FDA's approval of Plan B for nonprescription sales to women ages 18 and older (Knoy, "The Diane Rehm Show," WAMU, 8/28). The complete segment will be available online in RealPlayer and Windows Media after the broadcast.


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