Emergency Contraception Drug a Hot Potato at FDA
MICHELE NORRIS, host:
This is ALL THINGS CONSIDERED from NPR News. I'm Michele Norris.
ROBERT SIEGEL, host:
And I'm Robert Siegel.
When the government decided to keep a form of emergency contraception known as Plan B available only with a prescription, there was sharp criticism. The ruling by the Food and Drug Administration ignored an advisory panel's recommendation to allow over-the-counter sale of the pills. Some advocates called it a political move. Well, now questions are being raised about the role of religion in the actions of the FDA. NPR's Joanne Silberner has more.
JOANNE SILBERNER reporting:
Plan B is a series of pills started within 72 hours of intercourse to prevent pregnancy. What has brought Plan B to the fore again is a sermon by one of the FDA advisory committee members. The sermon was first described in an article appearing in The Nation magazine. It was delivered last October by obstetrician-gynecologist W. David Hager at Asbury College, a small religious school in Kentucky. As seen in a videotape, Hager told a fully packed chapel how Jesus had helped him stand up for what he believed in against the overwhelming majority of committee members.
(Soundbite of sermon)
Dr. W. DAVID HAGER (FDA Advisory Committee Member): You don't have to wave your Bible to have an effect as a Christian in the public arena. We serve the greatest scientist. We serve the creator of all life. We serve the author of all truth. All we're required to do is to proclaim that truth. Once again, what Satan meant for evil, God turned into good.
SILBERNER: He described a memo he wrote to the FDA outlining what he calls his scientific objections to Plan B, among them, that it might be used by young girls, that women wouldn't see their physicians or get advice about sexually transmitted diseases.
Dr. HAGER: I argued it from a scientific perspective, and God took that information and he used it, through this minority report, to influence a decision.
SILBERNER: That minority report was something Hager said he was asked to write, but he won't say now who asked him to write it. The memo has raised concerns among groups trying to get Plan B approved. Kristen Moore heads the Reproductive Health Technologies Project.
Ms. KRISTEN MOORE (Reproductive Health Technologies Project): We want to know who asked him to write that memo. Was it somebody in the White House? Was it somebody at HHS? Or was it somebody at FDA?
SILBERNER: Two Democratic senators, Hillary Clinton and Patty Murray, have gotten involved. They've asked the Department of Health and Human Services, which runs the FDA, to investigate. Patty Murray.
Senator PATTY MURRAY (Democrat, Washington): We want to know that there is no outside religious or ideological reasons for rejecting drugs or for putting drugs under the counters in our country.
SILBERNER: A spokesperson for the Department of Health and Human Services says HHS will respond to the request. In the sermon, Hager also said he was asked by the White House personnel office to join the Reproductive Health Advisory Committee in 2001 because there were some issues coming up that the White House felt were very critical. Today White House spokesman Scott McClellan disavowed a White House role in Hager's appointment.
Mr. SCOTT McCLELLAN (White House Spokesperson): In terms of the advisory panel that you're referring to, those are appointments made by the secretary of Health and Human Services. The secretary is one who appoints people to that advisory panel.
SILBERNER: David Hager said in a telephone interview that his opponents aren't objecting to his scientific concerns.
Dr. HAGER: It's because of Christianity. That's what people object to. And the point that I'm trying to make is that it is certainly possible to be able to evaluate data and to come to logical conclusions based on those data without incorporating your religious views or your faith into that decision process.
SILBERNER: But Hager's opponents say that since 24 of the 27 committee members who voted on Plan B felt there was enough safety evidence to sell it without a prescription, it should have been approved. When the FDA rejected Plan B last spring, they gave the manufacturer the opportunity to come back with more data and marketing plans. The company submitted the information to the agency last fall. The agency's response was due this January, but it has yet to respond. That delay has caused Democratic Senators Murray and Clinton to threaten to hold up the vote on the nomination of Lester Crawford to be FDA commissioner. Joanne Silberner, NPR News, Washington.