The sighting of an FDA official at the podium is one excellent reason to attend the annual Drug Information Association (DIA) meeting. It’s not that FDA officials say something new. (They’re trained not to.) Rather FDA presenters at industry conferences act as meta-anthropologists, explaining their own customs and cultural practices to outsiders.

That’s the drill, and it’s always helpful. An example at the 2009 DIA event in San Diego: the presentation of Jill Hartzler-Warner, the FDA’s acting assistant commissioner for accountability. Her topic: advisory committees and how the agency finds the experts who sit on them.

For starters, she pointed out, the selection process is more invasive than industry insiders may realize. No peer-reviewed journal, she said, looks at its authors as intently as the FDA considers potential advisory committee members. “It's akin to a financial colonoscopy,” Hartzler-Warner said. “It's not pleasant.”

Higher Standards

Spouses and children of prospective advisory committee members are examined as closely as the candidates themselves. Federal prosecution may result if there are errors or omissions in the papers filed by an advisory committee candidate. “A lot of the disclosures in peer reviewed publications—they're not the same type of disclosures that FDA looks at," Hartzler-Warner said. "The journals don't have a criminal provision that inspires people to be forthright. The scope of the [journal] disclosure is much narrower than what FDA requires.”

And the bar is being raised. Congress has expressed concerns about advisory members with special waivers of their conflicts of interest, and required that the numbers of such waivers decline over time. The FDA is trying to stay ahead of the levels mandated in the law. In 2007, 15 percent of advisory committee members had waivers. As of June 2009, she reported, the number was 6 percent. “We've made a lot of progress in reducing the numbers of waivers that are granted,” Hartzler-Warner said.

Bias Allegation

Hartzler-Warner indicated that an elite medical journal had published what the agency viewed as an improbable analysis of an alleged correlation between a) advisory committee rulings favorable to a sponsor and b) advisory committee members with waivers. The agency fiercely disputes the journal’s numbers. “We don't feel there is evidence of tainted and unreliable recommendations,” Hartzler-Warner said, largely because the authors of the article in question may not understand the data or the general FDA product review process as intimately as the agency itself.

We won’t mention the name of the journal, simply out of concern for the fragile psychological constitutions typically found in any editorial organization. But if readers wanted to speculate about a major journal based in Chicago, one perused by a large number of primary care physicians, they would be in the ball park of the erudite publication that earned the ire of the FDA.

The agency decided to order a consulting firm to compile a second, more informed numerical assessment of bias in advisory committee members. That firm duly reported findings exactly opposite of those in the academic journal. We'll leave it to the statisticians to sort out who's right.

Hartzler-Warner, meanwhile, is not the type to just haggle over the numbers. She’s a lucid, high-energy presenter. But she did note that the increased wariness about advisory committee members is exacting a cost, namely significant numbers of vacancies on advisory committees. As of the end of March, 2009, there were 171 open positions. Needless to say, in unspecified and unquantified ways, the U.S. regulatory process is probably not hastened by such vacancies.

Democracy In Action

Given the statutory need to make each advisory committee member a sort of deputized federal worker (without the salary or benefits)—well, let’s just say that filling those slots will not happen tomorrow. The FDA is using the internet to find new advisory committee members. It’s doing its utmost. “You can nominate yourself or another individual,” she said.

We know some readers are probably saving their strength for the autumn, hoping the economy isn’t permanently broken. They may wish the present story had just ended. Alas, journalistic thoroughness compels us to note that the fixation on the advisory committee waivers has lead to an unintended and (to our idealistic ears) unfortunate result.

Remember those demonized medical experts with waivers? The ostensibly compromised researchers and physicians Congress is so worried about? In studying their curriculum vitae and intellectual depth, the FDA has discovered that advisory committee members with waivers tend to be the ones with the biggest brains. The deepest expertise.

So the U.S. political realm has devised a way to quietly reduce the quality of the scientific advisory committee process. We're not casting aspersions on current advisory committee members. We are saying that slowly, inexorably, those who survive the hazing needed to be chosen for an advisory committee will be a bit less erudite, a bit less clinically savvy, than they might have been before Congress began working on the issue.