Medical-legal complications regarding clofazimine in the USA

Leprosy Mailing List – January 31^st, 2010

Ref.: Medical-legal complications regarding clofazimine in the USA

From: David M. Scollard, Baton Rouge , LA , USA

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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