WASHINGTON - If Congress offered the head of the Food and Drug Administration billions more to upgrade his embattled agency, he should be ecstatic, right?
But that wasn't quite the way FDA Commissioner Andrew C. von Eschenbach sounded yesterday at an unusual hearing before the House subcommittee on oversight and investigations.
The occasion was the reprising of a report in which several high-powered drug-industry and academic experts, including a University of Pennsylvania scientist, dissected the FDA. It said a persistent lack of resources over many decades had depleted the agency's ability to protect the citizenry.
"American lives are at risk," Gail H. Cassell, an executive at Eli Lilly & Co., who helped write the report, said at the hearing.
Among the report's findings:
The agency's computer systems are antiquated.
Its quality of science is backward.
Its morale is poor.
It is failing to protect consumers from the onrush of pharmaceutical ingredients and foodstuffs streaming in from overseas.
One expert, Peter Barton Hutt, who was the FDA's general counsel in the 1970s, yesterday suggested a doubling of the agency's $2 billion annual budget and a 50 percent increase in its staff over two years.
He noted that more than 100 statutes have increased the FDA's duties since 1988, without additional funding - even as more food and drugs are being imported. "The agency is barely hanging on by its fingertips," he told the committee.
Von Eschenbach was more measured than effusive during his testimony. He complimented the report, which he had requested from the agency's advisory Science Board, and said its findings were not a surprise. He also described himself as hard at work implementing its suggestions.
Von Eschenbach, however, would not say how much more money he had requested from President Bush in the fiscal 2009 budget. He said he would reveal that only after the president unveiled his budget next week, and he repeatedly resisted efforts by the subcommittee chairman, Rep. Bart Stupak (D., Mich.), to give up the numbers.
Von Eschenbach did say the problems at the FDA were entrenched and would take sustained efforts to overcome. "This is not going to get fixed with one intervention," he said.
The hearing was contentious for another reason. Usually, officials of von Eschenbach's rank speak first and are then allowed to leave.
But Democrats prevailed on von Eschenbach to sit through about four hours of testimony before getting his say.
Dale Nordenberg, a pediatrician and health-data expert at PricewaterhouseCoopers L.L.P., said 80 percent of the agency's computer network servers were operating beyond their recommended life span.
E-mail-system crashes hampered the FDA's response to a national E. coli outbreak in 2006, while critical data on drugs are sequestered in piles and piles of paper documents," Nordenberg said.
Garret A. FitzGerald, chairman of pharmacology at the University of Pennsylvania, noted that the FDA lacked a chief scientific officer to keep abreast of burgeoning developments.
The agency also is ill-equipped to do surveillance of drug side effects after a drug is approved, he said. "It took seven years from when we first predicted that [pain relievers] Vioxx and Celebrex would cause heart attacks for the evidence to accumulate" at the FDA and and for Vioxx to be removed from the market, said FitzGerald, who was instrumental in bringing those problems to light.