FDA's difficulty in staffing the Reproductive Health Drugs Advisory Committee is a result of a "broken process," Acting Commissioner Lester Crawford told a Women in Government Relations luncheon in Washington, D.C. Oct. 11.

While media and congressional attention is focused on ideological issues in the makeup of the committee, Crawford maintained that the more pressing problem is in the difficulty of finding members willing to take on the challenging position.

"We are struggling now to get people to serve on these committees," Crawford said. "You might say, 'Well, it's a great honor to be on an advisory committee.' I've been on about 20 of them, and it is not particularly a great honor."

"The other thing about it, it takes time. The briefing books that I used to get from the TSE Advisory Committee, for example, generally took three days to cover. And then you had a meeting that would be a couple of days." Committee members are giving up time that could be spent "consulting...for Chase Manhattan Bank or something," Crawford added.

"So, it is hard to get them. It is also hard to get nominations. And this is kind of a broken process."

Crawford acknowledged that there has been criticism about the recent selection of University of Kentucky professor W. David Hager, MD, to serve on the committee. Crawford reported that Hager will in fact be "interim chairman."

The Reproductive Health Drugs Advisory Committee currently has no official members; however, it will have to have at least two in order to meet for an upcoming review of the Women's Health Initiative study (see ¹ Also see "Prempro WHI Implications For Future HRT Trials To Be Discussed By Subcmte." - Pink Sheet, 14 October, 2002.).

The political sensitivity of subjects considered by the committee - particularly the abortifacient mifepristone - has brought scrutiny to the selection process.

Hager was selected "based on his credentials, and not based on his views on abortion or Christianity or whatever," Crawford declared.

"These committees are not being politicized," he said. FDA does seek "balance" in committee make-up, but "the balance that I am talking about...is the balance of scientific expertise."

"Having said that, I would defend the right of someone like the person who is currently under some scrutiny to serve. I mean, his credentials are unbelievably good," Crawford declared. "I think everyone agrees that he is an expert in the area, and because he happens to have become a lightning rod for one cause or another, does not mean that he is not qualified to serve as the interim chairman of this committee."

Senate Health Committee Chairman Edward Kennedy (D-Mass.) brought the advisory committee selection process into the public eye by asking FDA commissioner nominee Mark McClellan, MD/PhD, about the make-up of the reproductive health committee during an Oct. 7 confirmation hearing.

Kennedy expressed "strong concern about troubling reports...that the department is handpicking the members for its advisory committees not on the basis of best expertise and objectivity, but provided predetermined advice."

McClellan responded by stressing the importance of maintaining a "diversity of viewpoints" on advisory committees.

"I think that expertise and objectivity are important criteria for selection and I also like to add to that diversity of viewpoints," McClellan said.

In addition, "my understanding is the Federal Advisory Committee Act essentially requires that...HHS or FDA does not handpick members, but follows appropriate procedure for making sure that people selected to an advisory committee are well respected in their field of...the subject matter of the advisory committee and are willing to carry out their job effectively."

"You've got both my commitment for making sure that diverse expert views are heard and the law on your side for this one," McClellan said.

In follow-up written questions, Kennedy specifically identified his concerns with Hager. "You stressed the need for a 'diversity of viewpoints' in selecting FDA advisory committee members. Perhaps consistent with your testimony...FDA may be considering selecting Dr. W. David Hager for the Advisory Committee on Reproductive Health Drugs. Dr. Hager reportedly refuses to prescribe contraceptives to unmarried women and recommends Scripture readings for premenstrual syndrome," Kennedy wrote.

Kennedy questioned reports that FDA rejected former committee member Michael Greene, MD, Massachusetts General Hospital, as chairman.

Kennedy asked McClellan if he would ensure that if Hager were appointed to the committee, Hager would be recused from consideration of a citizens' petition filed by the Christian Medical Association in August requesting the withdrawal of mifepristone.

"Dr. Hager and a number of other diverse candidates have been considered as members of this advisory committee," McClellan replied. "Once selected, all members of the advisory committee may receive consideration to serve as its chair."

The status of mifepristone (RU-486, marketed by Danco as Mifeprex ) remains a politically difficult issue for FDA by injecting the agency into the broader debate over abortion.

Although McClellan received a warm reception and rapid approval from the Health Committee, the floor vote on his confirmation is on hold while Democratic Senators seek concessions from the Administration about SCHIP coverage policies for "unborn children".

FDA's approval of Mifeprex is widely viewed as the reason that former Commissioner Jane Henney was not asked to stay on in the Bush Administration, and several early candidates to succeed her are understood to have been asked up front for their positions on the drug.

McClellan was asked his position by Sen. Hillary Clinton (D-N.Y.) in the follow-up questions. His answer was in line with the Bush Administration's position as defined on the campaign trail: that the issue with RU-486 is one of postmarketing safety.

"The agency's review and approval of any drug adheres strictly to its statutory mandate and mission as a science-based public health agency," McClellan answered. "The appropriate legal and scientific standards are applicable to the review of all citizen's petitions, including this one."

"If confirmed, I intend to carry out my important statutory responsibility to monitor the safety of all approved drugs in actual practice," McClellan continued. "The enhanced postmarketing surveillance provisions in the recently-enacted Prescription Drug User Fee Act provide new tools and opportunities to do so."

FDA Reproductive Cmte. Membership Reflects “Broken Process” – Crawford

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