Senior FDA Officials Must Testify in Plan B Lawsuit
A federal judge in Brooklyn, N.Y., on Friday ruled that senior FDA officials must testify in a lawsuit attempting to force the government to allow nonprescription sales of Barr Laboratories' emergency contraceptive Plan B -- which can prevent pregnancy if taken up to 72 hours after sexual intercourse -- Long Island Newsday reports (Kerr, Long Island Newsday, 2/28).
FDA in May 2004 issued a "not approvable" letter in response to an original application submitted by Barr to authorize nonprescription sales of Plan B, citing inadequate data on its use among girls ages 16 and under. After FDA rejected Barr's first application, the company submitted a revised application to make nonprescription Plan B available only to girls and women ages 17 and older (California Healthline, 10/13/05).
In January 2005, FDA announced a delay in its decision on the revised application, after which the Center for Reproductive Rights -- on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others -- filed a lawsuit against FDA in a U.S. District Court in New York, claiming that the agency did not follow its procedures when it first denied the application.
The lawsuit also said that by not approving nonprescription sales, FDA violated women's right to equal protection and privacy as guaranteed by the U.S. Constitution (California Healthline, 1/24/05).
Federal Judge Edward Korman in December 2005 ruled that the lawsuit could continue. Friday's ruling, by Magistrate Judge Viktor Pohorelsky, comes in response to an FDA appeal to maintain the confidentiality of agency documents and correspondence about Plan B.
In his order, Pohorelsky said, "[I]nquiry about contacts between those outside the agency and those within the agency is appropriate to expose whether improper influences led to the FDA's actions" (Long Island Newsday, 2/28).
The Baltimore Sun and Washington Post on Friday and Monday, respectively, examined the statewide debates over access to EC. According to the Sun, the debates in the states "are the result of [FDA's] inaction for more than five years" on the application to approve Barr's EC Plan B for nonprescription sales (Rockoff, Baltimore Sun, 2/24).
"The FDA made this a major issue for state legislatures," Sharon Camp, president of the Guttmacher Institute, said.
Americans United for Life attorney Edward Martin said, "Basically, every state now has an effort going to either make Plan B more easily available or to slow it down or make sure that pharmacists don't have to dispense if they oppose it" (Kaufman, Washington Post, 2/27).