Any significant increase to FDA's 2009 budget may require more active involvement by the agency to restructure and recruit personnel than it has shown to date.

Rep. Bart Stupak, D-Mich., chairman of the Energy and Commerce Investigations and Oversight Subcommittee, pressed FDA Commissioner Andrew von Eschenbach for funding estimates needed to improve agency operations in fiscal 2009 at a Jan. 29 hearing.

But von Eschenbach declined to offer insight into FDA's monetary requests, withholding comment until the President releases the '09 budget Feb. 4. He instead focused dialogue on agency reaction to the Science Board's report - "FDA Science and Mission At Risk."

The panel's review identifies staffing and technology gaps, cites the need for new leadership positions and states that emerging scientific research is struggling in the agency's current state, among other shortfalls (¹ Also see "FDA Should Look Through IIRIS To Improve Science, Panel Says; Funding Is Worry" - Pink Sheet, 10 December, 2007., p. 15).

"I've disseminated that report within the agency and asked each of our center directors to directly respond to the recommendations [made] in that report, then forward their operational plan," von Eschenbach said. "Many of those things are already underway."

Von Eschenbach's lack of specifics may signal a difficult season for the agency on the Hill. FDA will often release news in advance of an appearance before Congress - announcing a label change on the eve of a hearing on safety, for example - to demonstrate its commitment to an issue.

The lack of focus by the agency here, though, suggests that despite an energetic outside lobbying push by the newly-merged Alliance For A Stronger FDA, the administration may not have committed itself to reinvigorating the agency's activities.

Without such a counter-narrative to offer, the agency can expect to see its activities and personnel scrutinized as Congress uses the controversy over the Vytorin trial results to fuel investigations into pharmaceutical companies' promotional and development operations (² Also see "Assault On Drug Marketing Tactics Becomes Drug-Specific On Capitol Hill" - Pink Sheet, 28 January, 2008., p. 19).

Despite the tension at the hearing, however, FDA has seemed to show some willingness in the past to work with Congressional appropriators to increase the agency's budget. The agency's Generic Initiative for Value and Efficiency followed an announcement by House Appropriations Subcommittee Chair Rosa DeLauro, D-Conn., who said FDA should issue a plan before Congress provides additional funds for ANDA reviews (³ Also see "GIVE Generics A Break: FDA Review Plan Draws Grumbles From Industry" - Pink Sheet, 8 October, 2007., p. 7).

Congressional Discontent On The Rise

At the hearing, Rep. Henry Waxman, D-Calif., stressed the need for FDA input and immediate action to improve agency efficiency before a large- scale public health emergency occurs.

"I don't know how much more evidence we need to realize that FDA is in a crisis. Our choice is clear: either we're going to make sure this agency has the ability and the resources necessary to do its job or we're going to watch it deteriorate," he said.

"We need the best information from the administration on how much funding FDA needs to resume its position as the gold standard for the rest of the world," Waxman added.

"I was disturbed that when the FDA asked its Science Committee to make a recommendation, [funding] is one area where they asked them not to make a recommendation - not to spell out how much money they may need to fulfill their responsibility - I hope that's not an indication of what we're going to see when we get the President's fiscal year '09 budget."

Waxman submitted a same-day letter with Senate Health, Education, Labor and Pensions Committee Chairman Ted Kennedy, D-Mass., requesting that the Government Accountability Office assess whether FDA's budget for drugs and devices has "kept pace" with inflation and increasing agency responsibilities.

Von Eschenbach Sugarcoats Subcommittee Findings

Rep. John Dingell, D-Ill., chairman of the Energy and Commerce Committee, challenged von Eschenbach during the hearing about the agency's "at risk" state.

Dingell presented von Eschenbach with several findings documented in the Science Board report regarding the agency's shortfalls, to which the commissioner avoided offering concrete answers.

Dingell asked von Eschenbach if he agreed with a statement in the subcommittee report that "FDA cannot fulfill its mission because its science is eroded and its scientific organizational structure is weak," to which von Eschenbach replied that he did not.

"I believe the science basis of FDA is strong but it needs to be stronger to respond to the many challenges and the changes that occur in the world of science and technology," von Eschenbach said. "It's at a level that needs to continue to improve."

Additionally, Dingell asked von Eschenbach to respond to findings that FDA reviews are seldom followed, to which he said that he has responded to external reviews he requested, noting that actions before his time in office are beyond his control.

Von Eschenbach did say he found import inspections to be "increasingly difficult."

The commissioner agreed with report findings that leadership positions within the agency should expand to include a Chief Medical Officer and a Chief Scientific Officer.

Questions of Risk and Mitigation Strategy

Stupak asked Science Board Subcommittee panelists what constitutes the agency's "at risk" status. In response, Science Board chairwoman Gail Cassell, who is Lilly's VP-scientific affairs, cited a lack of appropriate checks and balances within the agency needed to adequately monitor regulatory activities.

"One of the things that was pointed out in the self- assessment by FDA was indeed the fact that vaccine adverse event reports today are still being reviewed manually," Cassell said.

"We also made the observations, as have others, that there has been a tremendous increase in adverse drug events," she added. "Collectively then I think we can't reach another conclusion other than the fact that American lives are at risk."

Science Board members stressed the need for more resources in order to improve agency efficiency in the wake of increased Congressional attention.

- Carlene Olsen (c.olsen@elsevier.com)

Congress Spars With FDA On Budget Figures And Scientific Readiness

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