While the IAOMT continues its actions against the FDA's classification of dental amalgam on procedural and scientific grounds, and Consumers for Dental Choice presses its case on the FDA Commissioner's conflict of interest, FDA watcher Jim Dickinson writes of the terrible conflicts within the agency:

Obama Losing at FDA, Too

11/04/2009   [Commentary by Jim Dickinson*]

Just as Barack Obama has been portrayed as losing in the local elections yesterday — much as such elections can be written off as too local to matter — his team at FDA is also losing for the same perceived administration-wide failure to deliver on its promises. Yes, it’s unfair to expect they can overturn in 300 days what their predecessors did in 2,920 days plus the regulatory sloth of the Clinton years — but public disillusionment is showing nonetheless. Everyone can feel it.

At FDA, the pressure is a microcosm of the national experience, and maybe just as unfair. We were promised transparency, but the bureaucratic process to accomplish that is long and slow, like everything else that FDA does. And there are early signs that the bureaucratic process at the agency will emerge triumphant, as it always has.

The decidedly unsexy dental amalgam rule may be seen as a pointer. Foisted on the balky, slothful agency by a lawsuit last year after 32 years of bureaucratic stalling, the pressure-cooked final rule that emerged seven months into the Obama administration 8/4, was based on defective science and signed into law by principal deputy commissioner Joshua Sharfstein on the basis of underlying staff work he was too new to be responsible for, in a timeframe that was too short for him to personally analyze.

A lot like Nancy Pelosi giving a fractious House two weeks to vote on almost 2,000 pages of healthcare reform. Too much, too fast — and thus too little to meet expectations.

The disappointed get short shrift. In the case of the amalgam final rule, they were offered the chance of reconsideration in a three-month deferred effective date (11/4). But despite the filing of a timely petition for just that, the rule went into effect anyway. The Obama team’s grip on the bureaucracy below — like its grip on the public will in the face of Republican insurgency assaults — is simply too weak. Or “dithering,” to borrow a Karl Rove-ism.

Indeed, the brains behind the controversial rule, Susan Runner, dental branch chief in the agency’s most dysfunctional Center, CDRH, is allowed to review the petition for reconsideration. Her decision on its merits isn’t known yet, but since her hand has for most of the past three decades guided this matter within FDA, it may not be unreasonable to expect that she won’t reverse herself on it now. So what is the worth of “reconsideration,” or even asking for it? Petitioner James S. Turner told us 11/4 the agency is “ethically compromised” and is building a “record of insensitivity and lack of concern for public health” on amalgam; he expects it to be resolved in federal court.

Hardly the stuff of commissioner Margaret Hamburg’s No. 1 priority: restoring public trust in FDA. There might be no better example of the FDA bureaucracy’s resistance to external pressure to change. The agency has never reversed a decision it has made, notwithstanding any change in the White House.

This might be seen as a ringing endorsement through the ages that its internal review methods are faultless. After all, the federal judiciary almost always defers to the agency’s judgment, notwithstanding the Supreme Court’s recent undermining of the 1984 Chevron standard that established such deference in law.

In a way, all this shows the futility of elections — at least so far as the inner workings of agencies like FDA are concerned. “Commissioners come, and commissioners go — but we stay here,” as one now-retired CDER compliance official told us during the Reagan Revolution.

Would we have it otherwise — that new commissioners could revoke the GMP regulations on a political whim? Of course not. But why do commissioners routinely defer, as the courts do, to regulatory decisions made below? As we have repeatedly shown, such decisions do not go through a rigorous internal review-and-challenge process — as comparable decisions in industry do — before they are imposed on a company, industry or the public.

Instead, the initial field office manager’s (or review team leader’s) decision is signed off on up the line, in a rubber-stamp process that can take on a life of its own, reaching “critical mass” and entering the “my mind is made up, don’t confuse me with facts” terminal phase.

This one-way process seldom hits a “devil’s advocacy” challenge — the process is too committed to moving decisions forward. The more decisions and the more forward movement the better, no matter what the soundness of their individual foundations was. Challenging those foundations would delay the process, and might expose the challenging manager to loss of his or her tenuous grip on organizational discipline.

Challenges in the organization easily invoke a “circle the wagons” response, and the challenger may be frosted out of the circle of peers on which he or she relies for continued forward movement in his or her career.

Industry is complicit in this, because — like the judiciary — most CEOs defer to FDA when push comes to shove. Companies would rather “suck up” an adverse decision than challenge it, because as in the internal FDA review process itself, challenges only delay a process that is already too long.

Thus the promise of major internal reform already has two strikes against it: the inherent “nature of the beast” itself, and the reluctance of external constituencies to embrace the risks that revamping a system they’re familiar with would necessarily entail.

The battle isn’t over until the fat lady sings, of course, but as the voters said on Tuesday, confidence in the Obama “change” agenda is vanishing broadly.

* Jim Dickinson is editor of FDA Webview.