Barr Laboratories' Plan B Earnings Remain High Despite Critics' Efforts To Reverse FDA Authorization For Nonprescription Sales

Main Category: Sexual Health / STDs
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 27 Aug 2007 - 15:00 PST

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Earnings of Barr Laboratories' emergency contraceptive Plan B, which can prevent pregnancy if taken up to 72 hours after intercourse, remain high, despite critics' efforts to reverse FDA's decision to authorize the drug for nonprescription sales, the AP/San Francisco Chronicle reports (Crary, AP/San Francisco Chronicle, 8/22).

FDA in August 2006 approved Barr's application to allow nonprescription sales of Plan B for women age 18 and older. The approval of the application requires the company to monitor the effectiveness of the age restriction. Barr has agreed to send "anonymous shoppers" into pharmacies to test compliance with the age restriction, distribute a booklet about its proper use and exclude gas stations and convenience stores from selling the drug.

The Family Research Council and several other groups are suing FDA to overturn the Plan B decision, while the Center for Reproductive Rights is suing FDA to remove the age restriction for nonprescription access. EC also is the focus of debate on whether Roman Catholic hospitals or pharmacists who have moral objections to the drug's use should be required to dispense it. Fourteen states require hospitals to provide women information about EC, and at least 19 other states are considering similar measures.

Barr has advertised Plan B, which sells for about $50, in women's magazines. More than 54,000 pharmacists have completed an education program about the drug. The company in July said sales for the pill have increased from about $40 million annually to an expected $80 million for 2007. Barr would not release the actual number of Plan B units sold (Kaiser Daily Women's Health Policy Report, 7/16). According to the AP/Chronicle, all national pharmaceutical chains stock the drug, but some advocates say that some pharmacies and individual pharmacists are not selling the drug.

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"Overall, we've been very pleased with the acceptance," Barr spokesperson Carol Cox said, adding, "The product may not be for everyone, but if you find yourself in a position to need it, absolutely it should be available." Wendy Wright -- president of Concerned Women for America, which also is part of the FRC lawsuit against FDA -- said, "Barr may be making a healthy profit, but women are paying the price."

NARAL Pro-Choice America President Nancy Keenan said many women still are unaware Plan B is available without a prescription. "There's a lot of education that needs to be done," she said. Cecile Richards, president of the Planned Parenthood Federation of America, added that Plan B likely will contribute to a significant decrease in unplanned pregnancies once accurate information about it reaches a large number of American women. "We're talking about very mainstream health care here," and "yet there is a fringe group of folks in this country who seem determined to prevent women from getting emergency contraception," Richards said.

Deirdre McQuade, planning director for the U.S. Conference of Catholic Bishops' Secretariat for Pro-Life Activities, said she is concerned about the right of pharmacists to refuse to provide the pill. "Pregnancy is not a disease," McQuade said, adding, "There is no absolute duty to dispense a nontherapeutic drug, but there is a basic civil right of conscience" (AP/San Francisco Chronicle, 8/22).

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