The Debate Over Plan B

Did Religion Play Role In An FDA Decision?

(CBS) 
So, with Plan B mired in the abortion debate, the FDA advisory committee took its vote on recommending whether it should be sold over the counter.

Dr. Hager voted “no.” But his colleagues on the committee rejected his arguments, voting 23 to four in favor of offering the drug over the counter.

Such a lop-sided vote should have meant the application would sail through. But then the saga of Plan B took a strange turn.

Dr. Hager says someone at the FDA — he won’t say who — asked him to write a “minority report” in which he asked for more studies and more data on the use of Plan B by young girls.

A few months later something totally unexpected happened: The FDA ignored the committee’s overwhelming vote and rejected the proposal to sell Plan B over the counter, citing the very concerns in Hager’s report.

Some people believe Hager raised these objections because of his religious beliefs, but that’s something he denies. “The religious aspect did not enter into that decision for me,” he says.

But in to a speech he gave to a Christian college, he seemed to admit his role was all about religion. "God has used me to stand in the breach for the cause of the kingdom," Hager said at the time.

He was talking about Plan B.

"But I argued it from a scientific perspective. And God took that information and He used it through this minority report to influence a decision. You don't have to wave your bible to have an effect as a Christian in the public arena," Hager told the audience.

Hager says he did not mean to suggest that God wanted Plan B to fail, and that he was His instrument. "I thought that God used me, He'd used my individual gifts of, whatever, in an individual way to be able to express my opinion."

But with the speech, Hager may have fueled the fire of those who say that all he did was try to cloak religious beliefs in scientific language.

“If the idea in the population of this country is that a person can’t be a person of faith and also be a person of science, I strongly disagree with that,” says Hager.

Should agencies like the FDA be completely divorced from the debates that go on in society?

“Again, the question the agency has to deal with is, is it safe? And is it safe for teens? Yes, it is,” says Wood. “Have we asked that question about other contraceptive methods? Are we going to label, take condoms behind the counter? Make them prescription? I don't think we should.

“I think most Americans would like to leave those decisions as private decisions, and decisions within the family,” says Wood.

Plan B’s manufacturer, Barr Pharmaceuticals, submitted a new application to the FDA with an age cut-off, so that girls 16 and younger would still need a prescription to get the drug. This seemed to address Hager’s objections and those of the anti-abortion rights lobby.

But last August, then-FDA Commissioner Lester Crawford surprised just about everyone when he announced that the agency had postponed a decision on the new application for what could be months or years. He took the unprecedented step of overruling his own scientific staff.

“I think the Plan B decision to cut the scientists out is sort of a poster child of this concern about science and politics,” says Wood.

She’s talking about fears that religious forces are hijacking government decision-making. Wood was so outraged by the FDA postponement that she promptly resigned as director of the Office of Women’s Health in protest.

“What I saw was the science being ignored. That the scientific and medical staff (was) being cut out of decision making,” says Wood.

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President Bush's latest nominee to head the troubled FDA, Andrew Eschenbach, says he has no idea when a decision on Plan B might be made.

But since this story aired, several states have taken action on their own, pressuring pharmacies to honor Plan B prescriptions. One result: Wal-Mart, the nation's largest pharmacy chain, has reversed its long-standing policy and now carries Plan B.