1 department of health and human services




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7 supplemental testing, but we are going to permit algorithms

8 that don't use those tests. So, what we are trying to do is

9 indicate in the test label how you might comply with the

10 available guidance.

11 Now, you know, I would agree that we could drop it

12 from the test label but I am not sure that that would add

13 any help for users. Whereas, putting it in the test label

14 suggests that, you know, you are not done as a clinical

15 laboratory, and we still do want that message.

16 DR. HOLLINGER: Dr. Boyle?

17 DR. BOYLE: Since I started picking on the thing,

18 I would like to come full circle and say, although I think I

19 can wordsmith it better, the intent I think is reasonable.

20 The fact that there is going to be follow-up guidance on

21 exactly what is meant by some of the phraseology where we

22 basically said, beyond the use and diagnosis, is that it

23 could be used in a multiple test algorithm and we don't have

24 to go through a new approval process to get that added to

25 the label. Since that will simplify everybody's lives, I am


276 1 willing to forget what I said earlier and just -- you know,

2 I think it works pretty well with follow-up guidance.

3 DR. HOLLINGER: I certainly agree with that, and

4 maybe you can help me out of this, Jay. The problem I have

5 with this is, I mean, the whole idea with the rapid test was

6 that you could talk to people and give them information

7 before they left a clinical setting somewhere. And, then we

8 are hit with a label that says you have to have this other

9 possible thing, a supplemental test prior to patient

10 counseling. Am I missing something?

11 DR. EPSTEIN: Yes.

12 DR. HOLLINGER: Well, then help me.

13 DR. FINLAYSON: Let me say something because this

14 is almost instant replay. I had the same problem when I

15 first encountered this, and my reaction was, well, you can

16 do the first test in three minutes or five minutes or seven

17 minutes, and then you are going to make them wait for a

18 Western Blot? The answer is what Dr. Poffenberger is

19 proposing that you have another test there which will also

20 take only five minutes, or seven minutes, or ten minutes.

21 So, in a span of about 25 minutes you can get your answer

22 with enhanced accuracy. Maybe Dr. Poffenberger would like

23 to show that slide again in which she showed the worst case.

24 If you combine two tests together, the worst that you could

25 ever come out, in as much as you have already voted on


277 1 question one and said both sensitivity and specificity must

2 be at least 98 percent -- the worst you could ever come out

3 with is 98 percent/96 percent, or 96 percent/98 percent.

4 DR. HOLLINGER: John, I don't have a problem with

5 that. I mean, I totally agree with you but then essentially

6 what it is asking us to do, or me as I view it, is to vote

7 that there is a requirement for these multiple tests. I

8 don't have a problem with that either, but that is basically

9 what it is saying because, you are right, you do one test

10 and then you do another test and then you can do patient

11 counseling. But that is basically what it would say, that

12 we are not going to license a test just for a single test

13 only and then follow up with patient counseling. It is

14 saying you are really going to have to do both of these

15 tests and you are going to have to have another test. That

16 is what I am having a problem with.

17 DR. FINLAYSON: I don't work in this area so, see,

18 I have the overwhelming advantage of consummate naivete when

19 it comes to HIV test kits. But I read this as saying this

20 test may be used. It is not a requirement; it is a

21 recommendation, and it is not an FDA specific

22 recommendation; it is a Public Health Service

23 recommendation. And, this is saying this may be used this

24 way to fulfill that overall recommendation.

25 DR. HOLLINGER: I just wanted you to say that.


278 1 Yes, Dr. Macik?

2 DR. MACIK: I guess that is what I am kind of

3 getting back to. I understand Jay saying you want to get

4 across to them that you are not finished. But, how do we

5 want to put that? And, I think putting something like it

6 should be recognized that this diagnostic test must be used

7 in a way consistent with current Public Health, or whatever,

8 recommendations for validating the test before you counsel a

9 patient, or something like that -- in other words, still get

10 the message across that this test by itself doesn't end but

11 without bringing up the exact -- leaving it open to whatever

12 the reigning guidance is from the appropriate authorities

13 that this test should be used in concordance with that

14 guidance.

15 COL. FITZPATRICK: I am having the same problem

16 you are, Dr. Hollinger, with some of that, and that is

17 helping but is it feasible to drop the "prior to patient

18 counseling" part, and that fixes it?

19 DR. HOLLINGER: Well, that is basically what I

20 wanted to do, just take that last portion out. I guess we

21 could vote on it, and if the committee doesn't want to do

22 it, then they can decide not to. So, I will propose that we

23 modify or revise this -- that for the purposes of the vote

24 we revise this by taking out "prior to patient counseling"

25 and then vote on that. So, I would like to propose that as


279 1 a revision and if there is not a second we can go on from t

2 there. Is there a second to that motion?

3 COL. FITZPATRICK: Second.

4 DR. HOLLINGER: So we will vote on that. The vote

5 is to remove from this approach "prior to patient

6 counseling." Dr. McCurdy?

7 DR. MCCURDY: Blaine, I am continuing to have the

8 problem that I mentioned before, and I am not really sure

9 that helps. My suggestion is to split question two into

10 2(a) and 2(b), and 2(a) would be labeling for use as an aid

11 in diagnosis, which I think is pretty common for all

12 diagnostic test kits. The second one would then say you

13 should use some other kind of test. I think at one time it

14 was fairly common to use more than one liver function test,

15 but I doubt if the labeling of the kit said this may be used

16 as part of a multi-test algorithm. And, I think this is

17 basically clinical medicine and PHS guidelines, if they are

18 not too far delayed, would take care of this.

19 DR. HOLLINGER: Dr. Simon?

20 DR. SIMON: I a thinking that the FDA was trying

21 to be permissive and helpful to the public health sector

22 with this wording. Is that true? Because, if that is the

23 case, then I would want to be supportive and vote for the

24 wording.

25 DR. CHAMBERLAND: I agree with you, although I


280 1 think we need to hear from the folks at CDC who have been

2 working in this. This document that is in process about

3 testing and counseling, as I see it, I mean, again maybe

4 there would be words to wordsmith this a little bit better

5 but I see that second statement basically as saying that

6 this test can be used either as a single test where the

7 confirmatory test would be a Western Blot, and there may be

8 settings -- and other people in this room may know that

9 there may be settings where it is a better sequence to do a

10 rapid assay and do a Western Blot as the supplemental

11 confirmatory test, or it can be used as one of a series of

12 multiple rapid assays.

13 Maybe what people are reacting to is that there is

14 a sense that the first part of that is missing, that if you

15 use this as the sole rapid assay you need to have a

16 supplemental confirmatory test performed, the traditional

17 Western Blot or whatever. Are people feeling that this

18 somehow is missing that element? Because I don't feel as

19 strongly as others do on the committee about the need to

20 delete the language. I certainly would have no problem with

21 FDA or others maybe rethinking the language, and I don't

22 think we need to think that this is the final, final version

23 of the language. It seems like it is up for discussion, and

24 I think what they are trying to do is tell us what their

25 intent is, and maybe the feedback we are giving them is you


281 1 might need to work on the wordsmithing a little bit better

2 because it is not as clear as we would like.

3 DR. POFFENBERGER: I think you have really

4 captured what we were intending. We were intending to make

5 it an "or" situation. That is, you can either use it as a

6 single, initial rapid screening test or you may use it in a

7 combination. The recommendations, if it is used as a single

8 test, would still be in place. That is, the site would be

9 under Public Health recommendations to go on and do a

10 confirmatory Western Blot. So, what we are trying to do

11 here is be flexible and offer the option, and let it be up

12 to the testing site and the health professional running that

13 site as to which path they are going to choose.

14 DR. HOLLINGER: Which would mean that they could

15 counsel patients before they do that other confirmatory

16 test.

17 DR. POFFENBERGER: Yes, they can counsel the

18 patients but those recommendations are part of the PHS

19 recommendations. So, they would be following that and

20 presumably following the counseling recommended by the CDC.

21 DR. HOLLINGER: Well, with that understanding, I

22 would withdraw my -- if Col. Fitzpatrick will withdraw his

23 second.

24 COL. FITZPATRICK: I will certainly do that, yes.

25 DR. HOLLINGER: Let's vote on the intent of this


282 1 question. Does the committee agree with the FDA approach to

2 labeling the rapid tests? All those that favor that

3 question and are voting yes, raise your hand.

4 [Show of hands]

5 All those opposed, or voting no?

6 [No response]

7 Abstaining?

8 [No response]

9 Consumer representative? Mrs. Knowles?

10 MS. KNOWLES: Yes.

11 DR. HOLLINGER: And Dr. Simon?

12 DR. SIMON: Yes.

13 DR. HOLLINGER: Thank you.

14 DR. SMALLWOOD: Results of voting for question

15 two, unanimous "yes" votes. The consumer and industry

16 representative both agreed with the "yes" vote.

17 DR. HOLLINGER: Thank you. This concludes today,

18 but let me just mention about tomorrow. Tomorrow we start

19 at 9:00. The first three updates are going to take a little

20 bit of time, so I am hoping we are going to get out at 12:30

21 but it may be 1:00. So, you need to know that. So, we will

22 see you all tomorrow morning.

23 [Whereupon, at 5:45 p.m., the proceedings were

24 recessed, to reconvene at 9:00 a.m., Friday, June 16, 2000.]

25 - - -
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