Leprosy
Mailing List – January 31st, 2010
Ref.: Medical-legal
complications regarding clofazimine in the
USA
From: David
M. Scollard,
Baton Rouge
,
LA
,
USA
Dear
Prof. Ryan,
Your
question (LML Jan. 28, 2010) is a straightforward one but the answer,
unfortunately, is not straightforward, nor does it involve the usual
legal issues. The situation in the
United States
is, I believe, unique.
When
the manufacturers of clofazimine decided a few years ago that they
would no longer distribute clofazimine commercially in the
United States
, there were unexpected repercussions related to the drug approval
categories of the US Food and Drug Administration. The FDA
has strict rules about importation of medicines, and does not allow us
to accept clofazimine as it distributed through the World Health
Organization.
The
manufacturer kindly provides clofazimine to the National Hansen’s
Disease Programs at no charge, but only way that we can accept it and
distribute it (for use in Hansen’s Disease only) is under the FDA
category of an ‘investigational drug’.
(I know this appears bizarre, and I will not try to explain it
in more detail. It suffices to say that we have tried
strenuously but unsuccessfully to find an alternative).
To
use clofazimine as an investigational drug requires that physicians
must become investigators in a clinical trial that we supervise.
The protocol for treatment and follow up must be approved by an
Investigational Review Board (i.e., Human Studies Committee) in their
community. This approval must be renewed annually.
For
the clinics funded by the NHDP, this is an annoyance but is usually
not a major difficulty. However, for individual physicians in
many parts of the
United States
, who each see only a few patients in their private practices, this
involves a costly and overwhelming burden of bureaucracy and
paperwork, and as a result many of them will not use clofazimine.
In such instances we recommend minocycline as an alternative,
and our physicians and patients have usually been satisfied with this.
Fruitful
discussions are now underway that may simplify some parts of this
labyrinth and ease the burden somewhat. We certainly hope so!
Best
regards,
David
David
M. Scollard, M.D., Ph.D.
Chief,
Clinical Branch
National
Hansen’s Disease Programs
1770
Physician Park Dr
.
Baton
Rouge
,
LA
70816
Tel:
225-756-3713
FAX:
225-756-3819
E-mail:
DScollard(at)hrsa.gov
Web:
www.hrsa.gov/hansens
