FDA Doctor Says His Memo Helped Bar Contraceptive
17 May 2005
Senators Hillary Rodham Clinton (D-NY) and Patty Murray (D-Wash) on Thursday called for an investigation into whether a memo written by FDA adviser and conservative evangelical OB/GYN David Hager influenced the agency's decision not to approve... Barr Laboratories' application for nonprescription sales of the emergency contraceptive Plan B in May 2004, Reuters reports (Richwine, Reuters, 5/12). The agency issued a "not approvable" letter in response to Barr's original application, which would have allowed Plan B to be sold to any woman without a doctor's prescription. FDA's decision contradicted the recommendations of two agency advisory panels and cited inadequate data on the use of the pills among girls ages 16 and younger. Hager -- who was named an adviser to the FDA's reproductive drugs panel in 2002 -- during an October 2004 sermon in Wilmore, Ky., said that after the advisory panels voted to approve nonprescription sales of Plan B, he was asked to "write a minority opinion that was sent to the commissioner of the FDA." He added, "I argued it from a scientific perspective, and God took that information and he used it through this minority report to influence the decision." Hager continued, "For only the second time in five decades, the FDA did not abide by its advisory committee opinion, and the measure was rejected." Hager in an e-mail to the Washington Post said the request for the minority report came from "outside the agency," but he previously had told two other journalists that the request came from an FDA staff member. An unnamed FDA spokesperson said the agency did not ask Hager to write a report and that Hager sent a so-called "private citizen letter" to then FDA Commissioner Mark McClellan (Kaiser Daily Reproductive Health Report, 5/12).
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