Medical Device Daily Washington Editor

WASHINGTON – Yesterday’s hearing in the House Energy and Commerce subcommittee on oversight and investigations regarding the report titled Science and Mission at Risk: FDA’s Self Assessment was full of debates as to how seriously behind the times FDA may or may not be, with a heavy dose of discussion of FDA’s budget and information technology infrastructure.

Each of the committee members decried the lack of funding for FDA, but nobody from the House Appropriations Agriculture subcommittee, which has jurisdiction over the FDA budget, was present for the hearing. In any case, the agency’s chief was more optimistic about the agency’s state of affairs than the authors of the report.

Rep. Bart Stupak (D-Michigan), the chairman of the oversight subcommittee, said that “the agency now regulates $1 trillion in products,” but that FDA’s resources “have become wholly inadequate, given its expansive mission.”

Stupak noted that FDA commissioner Andrew von Eschenbach, MD, was the party who requested that the Science Board, an FDA advisory committee, examine the agency’s operations. Stupak said “some of the findings were shocking.” He noted that FDA has reduced food inspections by 78%” in recent decades, and said the Jan. 29 report on device inspections published by the Government Accountability Office showed that “the situation is truly alarming,” claiming that “American lives are now at risk.”

While Stupak decried what he said was FDA’s ill-conceived plan to close food labs,” among other moves, he acknowledged that the agency has been “asked to do more and more with less and less,” adding that “the deterioration is like a cancer that has developed over many years.”

Rep. John Shimkus (R-Illinois), the ranking minority member of the committee, said “the ability of the agency to carry out its mission has seriously deteriorated over the past couple of decades” and noted that the report “does not paint a pretty picture.”

“We will hear about obsolete information networks,” Shimkus noted, but he said that “the challenge today is to work together and move forward in bringing FDA” into the 21st Century.

However, not all was pleasant and light during the hearing, which featured three panels. Von Eschenbach was on the last panel, a condition that did not sit well with all the committee members.

Rep. Michael Burgess (R-Texas) said that the committee’s insistence on putting von Eschenbach on the last panel amounted to a waste of the FDAer’s time and was a break with historical practice for federal agency heads. “It should be unequivocal that he would be on the first panel,” Burgess asserted, saying that “this is a foolish way” to handle the hearing.

“We’ve got an approval rating of 10% right now,” Burgess added, questioning whether tying up an entire day of an agency head was appropriate, given the workload facing him.

However, Stupak was unmoved, stating that “if he comes back in 60 days, we’ll afford him that courtesy” and that Congress can burnish its image “by holding hearings.”

Gail Cassell, VP for scientific affairs at Eli Lilly (Indianapolis), who chaired the Science Board subcommittee that wrote the report, said that “due to the seriousness of the deficiencies found and the urgency” of the conditions at FDA, the board recommended publication in the Federal Register.

“Our report is unique in that it is only the second time in half a century that the agency has been reviewed” in its entirety instead of just a center.

“FDA suffers from serious scientific deficiency” and “if we think there are problems today, wait until the future. And the future is here,” she said.

“The deficiencies are agency-wide” and because of this, “American lives are at risk,” Cassell said. She said “the agency’s core programs have lost more than 1,000 people over the past decade,” adding that “it is time to argue for the reviews to stop and take action,” including beefing up recruiting and retention of scientific talent.

Peter Barton Hutt, a partner at the DC law firm of Covington & Burling (Washington) and a former member of the Institute of Medicine (Washington), said “FDA has become paradigmatic of the hollow government syndrome,” adding that Congress must commit to a two-year appropriations program” that would double funding and increase staffing by 50%. “Without these resources, FDA is powerless to improve its performance and will only fall farther behind” on its mission.

“In the history of our country, no federal agency has ever faced such an avalanche” of responsibilities without commensurate funding, Hutt added.

When he sat down to address the committee, von Eschenbach said “I am extraordinarily grateful for the productivity of this committee” in reference to the Science Board and that “I take their report very seriously.”

However, he said that FDA is already working on some of the issues noted in the report. “IT has been a major issue in the report,” and that while FDA “needs a modern technology infrastructure” to support its scientific mission, the work of rectifying those deficiencies is already underway. He said that when he came on board, FDA’s computer servers were about eight years old on average and working only at about 30% efficiency.

“The work has begun but the work is not finished,” von Eschenbach said, although he expects the bulk of the IT revamp to be done within about two years.

Stupak asked von Eschenbach if he felt that lives were at risk, as the Science Board report argues.

“No, sir, because I think that’s consistent with the things I’ve been addressing.” He said FDA recognizes “that the world is changing.” As to Hutt’s estimates of the funding needed, he said “I agree that FDA needs additional resources,” but the real task “is first and foremost to define what needs to be done.”

“I cannot agree with Hutt’s estimations [of budgetary and personnel needs] because they are just” estimates.

However, “this is not going to get fixed with one intervention,” von Eschenbach added.

Stupak grilled von Eschenbach on whether he felt the upcoming proposed budget by the White House for FDA was adequate, but the FDA commissioner repeatedly sidestepped the question, stating little more than that he will be in a better place to evaluate the numbers once the President’s budget proposal for fiscal year 2009 is published. However, von Eschenbach joins a long line of federal agency heads from both Democratic and Republican administrations who are or were not permitted to discuss the specifics of their budgets.