Conservative Doctor Says His 'Minority Report' Might Have Swayed FDA To Reject Nonprescription Sales of Plan B in 2004
May 12, 2005
A memo to FDA written by "outspoken" conservative evangelical OB/GYN and FDA advisory panel member David Hager played a "central role" in the agency's decision not to approve Barr Laboratories' application for nonprescription sales of the emergency contraceptive Plan B in May 2004, Hager said in October 2004 in a previously unreported public sermon, the Washington Post reports (Kaufman, Washington Post, 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. The agency'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 (Kaiser Daily Reproductive Health Report, 4/15). Hager—who was named an adviser to the FDA's reproductive drugs panel in 2002—said during a sermon at Asbury College in Wilmore, Ky., 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. Once again, what Satan meant for evil, God turned into good." 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."
Source of Request for Hager's Memo
Hager in an e-mail to the 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, according to the Post. 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. "We don't ask for minority reports and opinions," the spokesperson said, adding, "I've been advised that nobody from the FDA asked him to write the letter" (Washington Post, 5/12).
Current Status of Plan B OTC Application
Barr has submitted a revised application that would allow Plan B to be sold without a doctor's prescription to women ages 17 and older but be dispensed only with a doctor's prescription for girls ages 16 and younger. FDA in January was expected to rule on Barr's revised application but announced that month the decision would be delayed. On March 17, FDA Acting Commissioner Lester Crawford in a confirmation hearing to become commissioner of the agency told the Senate Committee on Health, Education, Labor & Pensions' that FDA would approve the application "within weeks." Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) last month said they planned to block a full Senate vote on Crawford's nomination after a meeting with Crawford and Sen. Edward Kennedy (D-Mass.) that ended without a commitment by Crawford about when FDA would make a decision on Barr's application. The committee last month decided to postpone a vote on Crawford (Kaiser Daily Reproductive Health Report, 4/15).
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily Reproductive Health Report, search the archives, and sign up for E-mail delivery at www.kaisernetwork.org/dailyreports/repro. The Kaiser Daily Reproductive Health Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2005 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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