FDA Failing to Protect Consumers, Lawmakers Told

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 Tuesday at an unusual hearing before the House Subcommittee on Oversight and Investigations.

The occasion was the reprising of a report, first released in December, in which several high-powered drug industry and academic experts dissected the FDA, saying that 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 and Company, 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 served as the FDA’s general counsel in the 1970s, suggested Tuesday 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.

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.

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 unveils his budget next week, and he repeatedly resisted efforts by subcommittee chair Rep. Bart Stupak, D-Mich., to give up the numbers.

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 Eschenbach’s rank speak first and are then allowed to leave.

But Democrats prevailed on Eschenbach to sit through some four hours of testimony before getting his say.

What he heard was chilling at times.

Dale Nordenberg, a pediatrician and health data expert at PriceWaterHouseCoopers, said 80 percent of the agency’s computer network servers were operating beyond their recommended life.

E-mail system crashes hampered the FDA’s response to a national E. coli outbreak in 2006, he said. Critical data on drugs are hard to access because they “reside in large warehouses sequestered in piles and piles of paper documents,” Nordenberg said.

Garret A. FitzGerald, chair 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 for Vioxx to be removed from the market, said FitzGerald, who was instrumental in bringing those problems to light.

The FDA is not on a “superhighway,” FitzGerald added. “It is stuck on a rural dirt road trying to get from place to place in a Model T.”

Several congressmen said they would like to see the agency receive more money. “In Texas, we would say `Your ox is in a ditch and you need help getting it out,’” said Rep. Gene Green, D-Texas.

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