| Trulytelling@yahoo.com 2006-01-09, 11:07 am |
| FDA Ophthalmic devices panel hearings - Dry Eye is discussed as an
'industry-wide problem', yet Alcon requests that it shouldn't have to
disclose dry eye risks to patients unless other companies are forced to
do so as well:
See the August 1, 2002 transcript for the approval of CustomCornea:
[url]http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.doc
[/url]
MR. McCARLEY: Yes, just very quickly. This is Rick McCarley.
One thing I would say is that if there are any recommendations I think
that the panel would make, in general terms, regarding LASIK, I think
it should be separated and then consideration should be taken by the
FDA of how you're going to get that out to the rest of the companies.
This dry eye issue, as far as I know, isn't inherent to this procedure
that you're discussing today for this application. So this is a new
issue that's industry-wide. I don't think this PMA application should
be burdened with having that as, you know, a portion of their labeling
while the other ones don't.
DR. WEISS: Dr. Bullimore?
DR. BULLIMORE: This is Dr. Bullimore.
I welcome the opportunity we have to set a precedent, and I would also
welcome the rest of the industry being asked to update their patient
and physician information to reflect the current climate. So I mean, if
you feel that the industry wants to come back to the FDA and update all
of the physician and patient booklets, I think the panel would be
generally supportive of that issue.
DR. WEISS: I can see them lining up.
(Laughter.)
More:
DR. PETTIT: With regard to the study, the dry eye issue, if the
patients had significant dry eye that could not be controlled with
drops and what have you, then they were excluded from the study. I
don't think we have a specific contraindication in the label to that
effect at the present time.
DR. WEISS: So would that be listed in the body of the study? Would I
find that in the body of the study, that the patients with
significantly dry eye were excluded?
DR. PETTIT: It's actually in the protocol, and we can find exactly
where that is.
DR. WEISS: So it's in the protocol, but would it be in the physician's
book? Because I don't see it in the physician's book.
DR. PETTIT: I don't know.
DR. WEISS: And I think Mr. Link's question would be then addressed to
why, if it was in the study, why would it not be in the physician's
book?
DR. PETTIT: It should be in the physician's book.
DR. WEISS: So just addressing myself to the panel and to Dr. Grimmett
who's scribing for me so kindly, maybe you can put that as an
additional.
Dr. Matoba?
DR. MATOBA: Alice Matoba.
But again, that applies generically to all LASIK, not to Custom
ablation, and we should separate out those things that we are
recommending specifically for Custom ablation and others that are going
to apply to all lasers and all LASIK.
DR. WEISS: But it is for this application. I think we run into a little
bit of a problem. The question is if you want to improve things, are
you prevented from improving things because you haven't improved them
before, and it would still apply to this PMA, although perhaps it
should have applied to other PMAs in the last couple of years. So we
don't want to be too burdensome. On the other hand, if we could make
things better for patients and doctors alike, we would like to.
So I'm going to defer to Mr. Whipple as to whether we should withhold
from making improvements because it would be unfair to this
manufacturer sponsor or whether these improvements will actually
improve the field and not be too burdensome.
MR. WHIPPLE: I think you can make those recommendations for approval
and we'll deal with them as we go through the labeling with the
sponsor.
DR. WEISS: And any of those who disagree with that on the panel,
obviously when that motion comes forward, you can disagree and vote it
down, if you so desire.
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