Dr. Hager's Family Values
Hager's FDA assignment is an object lesson in the potential influence of a single appointment to a federal advisory committee that in turn affects thousands, even millions, of lives. Witness the behind-the-scenes machinations that set the stage for the FDA's ruling against Plan B, a decision that the American College of Obstetricians and Gynecologists called a "dark stain on the reputation of an evidence-based agency like the FDA."
On December 16, 2003, twenty-seven of the FDA's advisers on women's health and nonprescription drugs gathered in Gaithersburg, Maryland, to evaluate the safety and efficacy of emergency contraception for over-the-counter use. (The Plan B pill, which drastically reduces the risk of pregnancy when used within seventy-two hours after intercourse, has long been available by prescription only; its advocates say its greater availability could significantly reduce the nation's abortion rate.) After a long day of highly technical deliberation, the advisers voted 23 to 4 to drop the prescription-only status of emergency contraception. "I've been on this committee...for almost four years, and I would take this to be the safest product that we have seen brought before us," announced Dr. Julie Johnson, a professor at the University of Florida's Colleges of Pharmacy and Medicine.
But on May 6, 2004, the FDA rejected the advice of its own experts and refused to approve the sale of Plan B over the counter. In his letter to Barr Laboratories, Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, claimed that Barr had not provided adequate data showing just how young adolescent women would actually use the drug.
That issue was never voted on by the committee. It was, however, broached by Hager at the meeting; he mentioned his concern for these "younger adolescents" several times.
In his private practice back in Kentucky, Hager doesn't prescribe emergency contraception, because he believes it is an abortifacient, and, not surprisingly, his was one of the four votes against widening its availability. But rather than voice his ethical opposition to the product, Hager emphasized his concern about adolescents, which other committee members have since called a "political fig leaf." According to Dr. James Trussell, who voted in favor of Plan B, the FDA had at hand six studies examining whether teens as young as 15 would increase their "risky" behavior if they knew they had a backup emergency contraceptive--and none of the studies showed any evidence for that contention.
In his sermon at Asbury College last fall, Hager proudly recounted his role in the Plan B decision. "After two days of hearings," he said, "the committees voted to approve this over-the-counter sale by 23 to 4. I was asked to write a minority opinion that was sent to the commissioner of the FDA.... Now the opinion I wrote was not from an evangelical Christian perspective.... But I argued it from a scientific perspective, and God took that information, and He used it through this minority report to influence the decision." [Emphasis added.]
None of the four panel members I spoke with for this article were aware of Hager's "minority opinion." An FDA spokeswoman told me that "the FDA did not ask for a minority opinion from this advisory committee," though she was unable to say whether any individual within the agency had requested such a document from Hager. This past January the FDA missed a deadline to respond to a new application from Barr Laboratories, and any forward motion on making Plan B more widely available has completely stalled.
Meanwhile, David Hager's stock has been rising among conservatives. Though his term on the FDA panel is set to expire on June 30, observers on both sides of the political divide anticipate his reappointment. In March I spoke with Janice Shaw Crouse, executive director and senior fellow at the Beverly LaHaye Institute, the research arm of Concerned Women for America. She is one of Hager's staunchest advocates in Washington (some credit her with engineering his FDA appointment); Crouse sits alongside Hager on Asbury College's board of trustees. In May, when informed of the allegations against him, she declined to revise her earlier statement. "I would not be at all surprised to see Dr. Hager elevated to a higher position or to another very influential position when it comes to women's care," she told me. "Because he has shown that he does care about women regardless of...the [religious] issues that people want to try to raise.... When people try to discredit him, he continues on. He hasn't caved in, and he hasn't waffled. He has been a gentleman. He is a person of character and integrity, and I think people admire that."