Sammie Young -- Hero

[Guest guest]

NATIONAL INSTITUTES OF HEALTH

OFFICE OF PUBLIC HEALTH PREPAREDNESS

CENTERS FOR DISEASE CONTROL AND PREVENTION

OPTIMIZING POST-EXPOSURE PREVENTION OF

INHALATIONAL ANTHRAX: ISSUES AND OPTIONS

Saturday, December 15, 2001

9:05 a.m.

National Academy of Sciences

The Auditorium

2100 C Street, N.W.

Washington, D.C.

http://www.bt.cdc.gov/DocumentsApp/Anthrax/12172001/1215HHSTranscript.pdf

Excerpt:

DR. FAUCI: Question.

DR. YOUNG: My name is Sammie Young. I'm

a retired Air Force Reserve Medical Service Corps

officer, and I spent 29 years and two months as

investigator and regulatory official with the Food

and Drug Administration. She was Kathy when I knew

her, when she came on board.

[Laughter.]

DR. YOUNG: So my question is in two parts

to Dr. Zoon. The first is I'd like for you to

clarify the 1985 efficacy review report on anthrax

vaccine which stated that there was not enough data

to make a decision on the aerosolized contact.

The order in accordance with the 1962

amendments to the Food, Drug and Cosmetic Act on

efficacy required that a proposal be published and

that the order be finalized in order to establish

the safety and efficacy provisions for a drug or a

biological. That order was never finalized. So we

have a vaccine out there that is spoken of as

approved, but yet the final order that would make

that approval effective has never been published.

That's my first comment.

The second one, Section 501(a)(2)( of

the Food, Drug and Cosmetic Act states amongst

others that a drug or biologic that has not been

manufactured in accordance with current Good

Manufacturing Practices is adulterated. We don't

administer adulterated drugs to human beings in the

United States, and that hasn't been done as far as

I know since, you know, the earlier days of the

'40s. So my question is how have you come to the

point that you can bypass a federal law and how you

can you assure that the people from CDC who are

going to get this vaccine that it's not adulterated

or misbranded and that it will be safe for them?

I have a little bit, a little more--well,go ahead.

DR. ZOON: Can I answer that, too? I'll

go look into why. I'm not aware of why the order

has not been published, but I will look into it.

Secondly, with respect to the vaccine, the

material that we're discussing, as I said, 063, is

currently an exhibit lot for a renovated facility

that is scheduled for inspection, and that has met

all the testing requirements as designated by the

specifications of the manufacturer and then

reviewed by lot release by CBER.

With respect to the FAV 015, which is the

lot that is low on Phemoral, I would say that we

would never license this product. However, with

full disclosure and informed consent on this

product and based on a risk assessment as to

whether or not this product was necessary, the

review of this lot was felt if there was indeed an

emergency it could be used under IND with full

informed consent.

DR. YOUNG: The material--may I get a

clarification? The material that is being used in

the IND is not the material that was manufactured

by the current manufacturer?

DR. ZOON: All the materials that are

being considered or made available to HHS are made

at BioPort. Some of it was made under the

conditions of its former--well, under the

conditions of its license, but it's not the one

with the supplemental changes to the facility and

the production procedures.

But this is the same vaccine that was used

in the Brachman studies and used in many other

states once it was approved.

DR. YOUNG: And looking at the material

that has been manufactured by the current license

holder, that material was produced during a period

when this company was not in compliance with

current Good Manufacturing Practices, which by

federal law and case law will support that, that

that product in quarantine is adulterated.

And as one who spent a lifetime in the

Food and Drug Administration in a career, we did

not permit the reconditioning of product that had

not been manufactured in accordance with current

Good Manufacturing Practices because you can't go

back and do something you didn't do in the first

place.

So how are we going to deal with the

material that is in storage? Now one last comment,

it's a recognized scientific premise or whatever

that end product testing alone is not sufficient

for the release of a drug product.

DR. ZOON: Just two comments on that. The

material was actually manufactured in 1992. And at

that time, the BioPort was not under an intent to

revoke or any of the conditions that we currently

have.

However, in saying that, I will agree with

you that we have looked at this. These lots would

never met the criteria for release for licensure.

And the only reason that these would be considered,

as I said, was an emergency situation with full

informed consent on the nature of the product and

what the deviations were, and quite frankly making

sure that was transparent so the individual looking

at this could be fully informed.

DR. YOUNG: Well, then a last comment on

that then. I have a lot of experience in the

investigational drug area, too. Will the informed

consent statement say to the people from CDC that

your product is legally adulterated?

DR. ZOON: I think it would lay out the

manufacturing deviations. It would also lay out

where it didn't meet spec.

DR. YOUNG: Thank you.

DR. FAUCI: Kathy, could I just ask you

maybe to--because there was a lot of legally

adulterated stuff going back and forth, and it

confused a lot of people--to perhaps just emphasize

the status of the 10,000 dose exhibit lot is an

ultimately licensable product; is that correct or

not?

DR. ZOON: It is. The only caveat to that

that I would say is that the inspection is ongoing.

DR. FAUCI: Right.

DR. ZOON: And the outcome of the

inspection could potentially impact on those lots

if significant problems were found. But if there

were none, then, yes, these meet all the

specifications, and if the inspection reveals that

they're made under good GMPs, then they would be

licensable.

DR. FAUCI: So they would be in

contradistinction to the 200,000, which would only

be used in an emergency under an IND?

DR. ZOON: Right.

DR. FAUCI: Just to clarify for the

audience.