WASHINGTON – British authorities on Wednesday confirmed the Food and Drug Administration’s contention that the agency first learned on Oct. 5 that Chiron Corp. would be barred from shipping half of America’s flu vaccine supply.
Also Wednesday, Chiron said the Securities and Exchange Commission launched an informal inquiry into how Chiron handled the disclosure of vaccine manufacturing problems that caused the nation’s flu shot crisis. The SEC declined to comment.
In a statement released by the FDA, the head of the U.K. Medicines and Healthcare Products Regulatory Agency said Chiron’s plant was inspected Sept. 28-30.
“Contrary to some reported statements, MHRA, as the responsible regulatory authority in the United Kingdom, made the decision to suspend Chiron’s license after an internal meeting Oct. 4 and first informed the company and the FDA of this decision Oct. 5,” said Kent Woods, MHRA’s chief executive officer.
The FDA said Chiron also confirmed that it was told of the British decision Oct. 5.
Media accounts late last week suggested the FDA had been tipped off to intractable contamination problems at Chiron’s Liverpool plant in mid-September. The FDA on Monday refuted the assertion.
As recently as two weeks ago, Chiron chief executive Howard Pien testified before Congress that the company had lost only about 4 million doses and fully expected to help meet the nation’s flu vaccine needs.
Also Wednesday, Rep. Tom Davis, R-Va., chairman of the House Government Reform Committee, and the ranking Democrat on the panel, Rep. Henry Waxman, D-Calif., demanded inspection reports, correspondence exchanged between the agency and Chiron, and a timeline of actions taken by the FDA on the matter from Aug. 1 to Oct. 5.
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