Thursday, May 12, 2005

Memo May Have Swayed Plan B Ruling
Memo May Have Swayed Plan B Ruling
FDA Received 'Minority Report' From Conservative Doctor on Panel

By Marc Kaufman
Washington Post Staff Writer
Thursday, May 12, 2005; A02

Soon after the Food and Drug Administration overruled its advisory panel last year and rejected an application to make an emergency contraceptive more easily available, critics of the agency said it had ignored scientific evidence and yielded to pressure from social conservatives.

The agency denied the charge, but an outspoken evangelical conservative doctor on the panel subsequently acknowledged in a previously unreported public sermon that he was asked to write a memo to the FDA commissioner soon after the panel voted 23 to 4 in favor of over-the-counter sales of the contraceptive, called Plan B. He said he believes his memo played a central role in the rejection of that recommendation.

The new information comes from a videotaped sermon in October by W. David Hager. On the tape, he said he was asked to write a "minority report" that would outline why over-the-counter sales should be rejected.

Speaking at the Asbury College chapel in Wilmore, Ky., Hager said, "I was asked to write a minority opinion that was sent to the commissioner of the FDA. For only the second time in five decades, the FDA did not abide by its advisory committee opinion, and the measure was rejected."

Hager told the group that he had not written his report from an "evangelical Christian perspective," but from a scientific one -- arguing that the panel had too little information on how easier availability of Plan B would affect girls younger than 16. The FDA later cited that lack of information as the reason it rejected the application.

"I argued from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision," Hager said. "Once again, what Satan meant for evil, God turned into good."

The videotape of Hager's sermon was first obtained by the magazine the Nation, which published a story about the doctor today.

In an e-mail to The Washington Post, Hager said the request for the report came from "outside the agency," but he had previously told two other journalists -- in one case in an e-mail that the recipient saved -- that the request came from an FDA staff member.

An FDA spokeswoman said yesterday that the agency did not ask Hager to write a report and that Hager sent what she called a "private citizen letter" to Commissioner Mark McClellan. "We don't ask for minority reports and opinions," she said. "I've been advised that nobody from the FDA asked him to write the letter."

Hager has been a highly controversial figure because of his strong views against abortion and emergency contraception and in favor of abstinence education. In his October sermon, he said that Christians such as himself were at "war" with people who would take faith and values out of medical care.

Hager was appointed by the FDA to the Reproductive Health Drugs Advisory Committee in 2002 and reappointed last year. A prominent Kentucky obstetrician and gynecologist, he has written numerous books on women's health -- generally from an evangelical Christian perspective.

In his October sermon, Hager said that White House officials called him in June 2001 and asked him to serve in some capacity -- initially as a candidate for surgeon general and later as a member of two advisory boards. After one month, Hager said, he was called by the White House and asked to resign from those committees and join the FDA's reproductive drugs panel instead because "there are some issues coming up we feel are very critical, and we want you to be on that advisory board."

While the FDA sometimes rejects the recommendations of its expert panels, the Plan B case was highly unusual in that the vote was so lopsided in favor of over-the-counter sales and its own science staff had also strongly favored approval.

Plan B has been available with a prescription since 1999. Barr Laboratories, its manufacturer, applied for permission to sell it without a prescription in 2003, arguing that it could reduce the number of abortions from unintended pregnancies. Emergency contraception generally works if it is used within 72 hours of unprotected sex.

Social conservatives in Congress, and many others opposed to abortion, have spoken out against the Plan B application, saying it would encourage unsafe sexual behavior.

Barr submitted a modified application in July 2004, and the agency was supposed to announce its decision in January. Instead, it said it needed more time.