I'm certainly on the fence regarding the mandatory vaccine issue.
However thousands of children have been injured or killed by vaccines
and ....well is the FDA REALLY Paying attention? Can parents believe
the FDA with 100% confidence? Many Dunderhead Pedeitricians are mostly
reliant on their Pharm reps >CDC, FDA bulletins for clinical decision
making eh?

By Anita Manning, USA TODAY
The head of the Food and Drug Administration on Monday strongly
defended his agency's oversight of a flu vaccine factory that was
abruptly closed down last week because of safety concerns.
Lester Crawford, acting FDA commissioner, said the agency had no hint
of escalating concerns at the Liverpool, England, plant before British
authorities suspended the plant's license last Tuesday. Until that
happened, Crawford said, the FDA had been assured by the company,
Chiron (CHIR), that contamination reported Aug. 25 was limited and
that 46 million to 48 million doses would be shipped to the USA early
this month.

Instead, the USA will face the coming flu season with roughly half the
100 million doses it expected.

British health authorities have said they believed the FDA had been
notified of ongoing problems at the Chiron plant as early as
mid-September, but Crawford disputed that. "I want to refute as
strongly as possible the contention ... that FDA knew before Oct. 5
there was indication of a problem serious enough for (British
regulators) to suspend Chiron's license," he said.

Chiron and the FDA had held weekly telephone conferences since late
August, he said, and British regulators may have thought Chiron had
told the FDA of increasing concerns, but that was not the case.
Crawford said no warning of the license suspension came from the
company or the British health department.

This week, five FDA and two British scientists are inspecting the
Liverpool factory. Crawford said he expects their report this week,
but U.S. health officials have said it's doubtful the vaccine can be
used.

When FDA officials last conducted a full inspection of the Chiron
plant, in June 2003, they detected contamination of some vaccine, but
Crawford emphasized it was unrelated to the current situation. FDA
officials were again at the factory in August this year to inspect a
newly renovated area. When told the company had detected the presence
of serratia, a bacteria, in some vaccine lots, "They looked at the
records and made some suggestions."

At that time, no full inspection was conducted. Some critics have
complained that the FDA did not take action.

"While the company was assuring the public that the problem was under
control, and while FDA was reviewing the company's investigation,
British regulators sent a team of inspectors that shut the plant
down," Rep. Henry Waxman, D-Calif., said Friday.

Crawford said the FDA followed standard procedures, and he would not
change anything the FDA has done. "This is the way we've always done
it, and it's worked very well in the past. So, no, we would not have
altered the procedures."