In case the administration’s deceptive propaganda cast doubt on the question, newly released documents from a House committee investigation into the flu vaccine shortage show how breathtakingly incompetent the FDA was in addressing the problem.
The Food and Drug Administration found serious problems of bacterial contamination at an influenza vaccine plant in England in 2003, 16 months before British regulators effectively closed the site and impounded its flu shots because of fears they were tainted.
Those earlier problems were among many revelations in about 100 pages of documents released yesterday by a House committee looking into how the United States lost about half this winter’s flu vaccine supply just as the season for giving the shots began.
The documents, which include FDA inspection reports, letters and e-mails, also revealed that the agency was nine months late in giving Chiron Corp., the owner of the plant, a detailed report of the problems it found and then rebuffed the company’s efforts to learn more about what it could do to fix things. At the same time, FDA managers overruled its inspection team and made its fixes voluntary rather than mandatory.
The new information appears to undercut the agency’s assertions that it had no reason to suspect that past safety problems at the plant had persisted and might threaten its huge production capacity.
Appears to undercut? How much more culpable could Bush’s FDA be? The agency knew about the contamination, sat on the results for months, and took steps to impede corrections.
“FDA’s laxity has had a heavy cost. If FDA had ensured that the problems identified in June 2003 were fixed, this year’s flu crisis might never have happened,” said Rep. Henry A. Waxman (Calif.), the ranking Democrat on the House Government Reform Committee.
Of course, if recent patters hold true, those who were responsible will be immediately promoted to higher government posts where they can do far more damage.