In this Administration, inconvenient facts are simply ignored," said Rep. Henry Waxman. "This is a dangerous way to govern."

The flu vaccine debacle came to light on October 5, when British regulators shut down a facility operated by vaccine manufacturer Chiron in Liverpool, England, due to contamination. The shutdown caused the United States to lose approximately half of its expected supply of flu vaccine.

Oversight Questions

Waxman posed three important oversight questions:

1. How did the United States came to depend on just two companies for flu vaccines?

2. Why did the vaccine shortage lead to such confusion and chaos?

3. Did FDA do its job to protect the U.S. vaccine supply?

As for the first question, several government agencies, including the Institute of Medicine, the Government Accountability Office, and the National Vaccine Advisory Committee have issued reports "exposing the weakness of our national vaccine infrastructure," Waxman told the hearing. "We cannot afford to continue to ignore their recommendations."

The reason underlying the chaotic response to the current shortage, Waxman suggested, is that the U.S. has not developed a plan to make sure people at highest-risk would be immunized if a shortage should occur -- despite warnings issued by the GAO over the past four years. "The seniors who have been standing in lines for hours trying to get a flu vaccine know that GAO was right," Waxman said.

FDA Failure

The California Congressman reserved his most scathing indictment for the Bush administration and the Food and Drug Administration, noting that senior officials, including Acting FDA Commissioner Lester Crawford, have reassured the public that the agency did everything possible to protect the vaccine supply.

Based on the committee's review of more than 1,000 pages of documents relating to the FDA's oversight of the flu vaccine problem, as well as meetings with FDA officials and interviews with British and Chiron officials conducted in England by a bipartisan team of the committee's staffers, Waxman concludes that FDA failed to provide effective oversight.

"Expert scientists at FDA knew about serious problems at the Liverpool facility in June 2003, but there was not sufficient leadership at the agency to ensure that they were fixed," Waxman told the hearing.

He noted that the Chiron plant in Liverpool was entrusted with manufacturing half of the U.S. supply of flu vaccine despite having had a history of contamination problems. "The plant should have received the highest priority from FDA," he said.

"What we are witnessing is the dismantling of FDA's enforcement and oversight capabilities," Waxman charged. "In area after area, the agency is failing to enforce the public health laws that Congress enacted. Enforcement actions for misleading drug advertisements have dropped 70% since 2001. Enforcement actions at vaccine plants and other manufacturers of biologic drugs have dropped over 80%. Key food labeling laws are being ignored. And there is no better example of what s wrong at FDA than its failures at the Chiron vaccine facility."

History of Problems

In June 2003, a team of FDA inspectors found 20 serious problems at the Chiron plant, Waxman said, including bacterial contamination and poor sanitary practices. The team recommended official enforcement action, but the FDA rejected that advice, asking only that the company make voluntary reforms.

The FDA later justified that decision by saying it thought conditions were improving. But the problems mushroomed over the next 16 months, Waxman said.

"FDA never once revisited the plant to see if Chiron was correcting its problems and making safe vaccines," Waxman told the hearing. "Incredibly, FDA remained passive even after August 25, 2004, when Chiron disclosed that millions of doses of vaccine were contaminated by a potentially lethal form of bacteria."

British regulators behaved responsibly, the congressman noted. They inspected the plant, reviewed it production records and convened meetings with experts. "By contrast, FDA conducted oversight by conference call," said Waxman, "trusting a stream of false assurances by Chiron that the plant had no serious problems. FDA conducted no inspection; it reviewed no plant records; and it was caught completely by surprise when British regulators shut down the plant on October 5."

Dangerous Way to Govern

The public has paid a heavy price for FDA's laxity, according to Waxman. "If FDA had ensured that the problems identified in June 2003 were fixed, this year s flu crisis might never have happened," he asserted. "And if FDA had responded aggressively to the contamination problems in August, our public health system would have had critical extra weeks to prepare for the shortage and to avoid the chaos that ensued in October."

FDA seems unwilling to learn from its mistakes, according to Waxman. In fact, "the Administration has been unwilling even to admit them," he said. "In recent weeks, the President, the HHS Secretary, and the Acting FDA Commissioner have all reassured the public that FDA did everything right. The Acting Commissioner has even indicated he would do it all over again the same way.

"After the flu crisis broke, Dr. Crawford told the public that the June 2003 inspection had no relevancy to the problems found in 2004. He said that FDA monitored the actions of Chiron and ensured that the violations found in 2003 were corrected. And he said that the U.S. and British regulators acted in synchrony. None of these statements were true. In this Administration, inconvenient facts are simply ignored.

"This is a dangerous way to govern and it is particularly hazardous for the public health," Waxman said.