FDA Chief Faces Wrath of Congress

April 22, 2008— -- Under the cloud of contaminated heparin deaths, Food and Drug Administration Commissioner Andrew von Eschenbach received a rude welcome from Congress Tuesday, accused by Rep. John Dingell, D-Mich., of "carrying the water" for the Bush administration, "toe-dancing around the hard facts," and making promises that turn out to be nothing more than "hooey."

"Commissioner, I have no ill will towards you," Dingell said. "I have ill will of the most gross sort towards the fact that you come up here and defend a situation that is indefensible and that you are not soliciting the resources that you need to do your job to protect the American people the way the law says you should. And that you are tolerating an administration which is allowing this kind of situation to continue, because they are too damn tight to see to it that the American people have the funds that are necessary to protect them against wrongdoing in foreign countries."

Estimates suggest more than 80 percent of all active ingredients used by U.S. drug manufacturers come from abroad. But the FDA only inspects foreign drug plants about once every 13 years, compared to every two to three years for domestic plants, according to the Government Accountability Office. The GAO finds that China's drug plants are inspected once every 30 to 40 years.

FDA officials said Monday that as many as 81 deaths and hundreds of severe reactions among patients taking the blood thinner heparin have been traced to a man-made contaminant from China. Chinese officials disputed these claims, saying the contaminant is not the cause of the problems.

In light of the heparin situation, von Eschenbach told lawmakers at Tuesday's hearing of his plans to improve the FDA's system that currently inspects only about 10 to 20 of China's 700 registered drug firms per year.

He said the agency's response to growing challenges in a "rapidly and radically changing world" has not been adequate.

"In addition to addressing the need to increase our inspections, we also need to overhaul the entire system," von Eschenbach said.

The FDA plans to establish permanent overseas offices in numerous countries, including China, to help address the problem. More foreign plant inspections than ever were conducted by the FDA in 2007, dedicating about $10 million to the process. But GAO analysis said it would cost the FDA $67 to $71 million each year to inspect the thousands of foreign plants on the agency's priority list.

Still, von Eschenbach told the House Subcommittee on Oversight and Investigations that in heparin's case, even if the Chinese plant had been inspected years ago, "we would not have detected that contamination" because the test to detect it was just developed.

But subcommittee chairman Bart Stupak, D-Mich., disagreed, arguing that "the lack of inspections actually encourages a less safe product in some of these plants."

"I've been talking to Food and Drug Administration commissioners for 40 years," Dingell said. "And you're not the first fella I've had to skin for not doing his job and coming up here and defending an indefensible situation. So, I want to maintain my respect for you but I can't maintain my respect for you if you keep toe-dancing around the hard facts that curse you with the inability to do your job because you don't have the resources."

The GAO's health care director, Marcia G. Crosse, said that, although the FDA is making progress, short-term risks still remain.

"FDA's plans represent a step forward in filling the large gaps in FDA's foreign drug inspection program, but do little to accomplish short-term change," Crosse said.

The GAO said, as early as 1998, that the FDA needed to improve its foreign drug inspection program. Last November, the GAO released a report revealing that the FDA was unaware how many foreign drug makers were sending their drugs to the U.S.

The GAO noted one database showed 3,000 registered makers and another revealed that 6,800 makers actually shipped their drugs into the country last year. The report placed blame on a serious lack of human and economic resources, flaws in FDA databases and IT systems, and inadequate permanent operational support in foreign countries.

"How can there be any confidence that the FDA is adequately regulating foreign drug firms when the FDA has no idea who's making what, where they are physically located, and when they were last inspected?" asked Stupak.

"Last year, this nation's regulatory failures resulted in dead dogs and cats; this year, it has tragically led to the deaths of people," Stupak said. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next 'melamine' or 'heparin' tragedy will soon be upon us."

"The FDA can be re-built but it will be expensive," said Carl Nielsen, retired director of the FDA's office of regulatory affairs. "The public health cost is higher, though, if no significant investment is made, as demonstrated by the heparin incident."