Top One Hundred Countdown -- Anthrax Vaccine Quotes - #98

[Guest guest]

House Armed Services Committee testimony, 13 Jul 2000:

Dr. -Winegar and DepSecDef Rudy DeLeon admitted, in the testimony

quoted below, that the FDA would not have allowed the Michigan plant to

manufacture any more vaccine:

Mr. SHAYS. And the FDA basically shut down the old plant. Isn't that correct?

Secretary DE LEON. I would ask Dr. -Winegar, since she has been

our action officer.

Dr. JOHNSON-WINEGAR. Sir, the FDA did not shut down the plant. The plant

was scheduled for renovation and upgrade and that was initiated. In the

meantime, these lots-

Mr. SHAYS. Didn't the FDA make it clear that they would not approve any more

from this old plant and that they needed to upgrade it?

Dr. JOHNSON-WINEGAR. Yes.

Mr. SHAYS. And that is a matter of public record, correct?

Dr. JOHNSON-WINEGAR. Yes.

Secretary DE LEON. Correct.

Mr. SHAYS. Didn't the FDA make it clear that they would not approve any

more from this old plant and that they needed to upgrade it?

Dr. JOHNSON-WINEGAR. Yes.

Mr. SHAYS. And that is a matter of public record, correct?

Dr. JOHNSON-WINEGAR. Yes.

End of excerpted testimony.

Major L. " Buzz " Rempfer