Wednesday, April 02, 2008

FDA’s 12-Step Program

The first step in any recovery is recognizing that there is a problem.

Based on a recent shift in public comments, it sounds like FDA Commissioner Andrew von Eschenbach has accomplished that important first step in a recovery program for the agency: he is now acknowledging publicly what others have been lamenting for some time—that FDA has reached a crisis point in its ability to complete its mission with its available resources.

While von Eschenbach says he first recognized the resource issues soon after joining the agency, he is starting to become more forceful and use stronger language than in previous public appearances.

The change in tone began with an interview that appeared in the Wall Street Journal on February 27, in which von Eschenbach sought to correct a misperception that he didn’t think FDA needed more resources. He followed that with a keynote address two days later at the National Press Club, during which he talked about the “potential for tremendous peril” during a time that he referred to as a “turning point” for FDA.

But the real change seemed to come during what is likely to be von Eschenbach’s final keynote at the Food & Drug Law Institute’s annual meeting last week. Using a term he has largely avoided in the past, von Eschenbach acknowledged that the agency is in the midst of a “crisis” as it struggles to meet all its responsibilities on a shoestring budget.

“This agency is burdened with an enormous portfolio of responsibilities of incredible scale and scope that have been growing over time,” he said. “And they have been growing in a manner that is somewhat akin to children putting ornaments on a Christmas tree. Each one of them maybe very important but the process was done without planning without precision and without prioritization.”

That increase in regulatory mandates is “further complicated by one more catastrophic element added to this formula for potential disaster,” he said. “All of this in context of uncontrolled expansion and accelerating complexity compounded by in effect reduction in resources available at FDA with which to cope with these changes.”

Those reductions—which prevented FDA’s budget from keeping pace with inflation—“were so subtle that when one looks at the bottom line, there was an apparent deception,” von Eschenbach said. The agency’s work force appears adequate on the surface, but in reality is overextended, aging, unstable and “working and coping with inefficient tools.”

Those statements come in stark contrast to von Eschenbach’s testimony during House Energy & Commerce Oversight & Investigations Subcommittee hearing just two months ago. The hearing—called by subcommittee chairman (and persistent thorn in FDA’s side) Bart Stupak—discussed an FDA Science Board report released late last year that described an agency “at risk” and unable to meet its scientific mission.

Von Eschenbach was asked to comment on the findings, and whether the agency needed more money to complete its mission. The commissioner chose his words carefully: while acknowledging that he had asked HHS Secretary Michael Leavitt for more appropriations for fiscal year 2009, he refused to specify how much, given that the hearing was held before President Bush had released his proposed budget.

And in an exchange with Rep. John Dingell (D-Mich.), von Eschenbach commended the FDA Science Board for its work on the report, but disagreed with the notion that FDA’s scientific base is weak. “It’s not that it’s bad,” he said. “It’s at a level of excellence that needs to continue to improve, and continue to expand.”

Since then, the Administration released a budget proposal that gives a 2.9% increase in appropriations (we wrote about that here), and von Eschenbach started to become a little more vocal about what it will take in monetary resources to get the agency back on track.

That should come as welcome news for the biopharma industry. Simply put, an underfunded, overworked agency is bad for drug sponsors. As we reported in The RPM Report this month, inadequate resources in FDA’s drug center resulted in a decision to prioritize the implementation of new drug safety standards ahead of product reviews.

Drug sponsors should hope FDA continues on its recovery path. FDA and von Eschenbach have achieved the first step; in the typical 12-step recovery program, the second step is believing that a higher power can restore sanity. Perhaps that's where Congress comes in.

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