February 16, 1999
FDA Office of Orphan Product Development (HF-35)
5600 Fishers Lane
Rockville, MD 20857
Dear Ms. Hubbard,
We spoke several weeks ago regarding my questions concerning the letter from your office dated December 21,1998. In that letter, MAPS' request to have marijuana declared an orphan drug for AIDS wasting was rejected for the third time.
This time, the rationale for the rejection was stated as follows: "We have concluded that smoked marijuana will be used in a broader population than AIDS patients experiencing involuntary weight loss of greater than 5% after their AIDS diagnosis." I'm writing now to request clarification of that statement. Are you referring to off-label prescriptions? If so, I was under the impression that such uses would not disqualify an application for designation for an orphan disease whose patients numbered under 200,000 per year. I think I have presented a convincing case that the numbers of AIDS wasting patients, as defined by my last submission, are well under 200,000.
About five other drugs have been designated as orphan drugs for AIDS wasting, using a definition slightly different than the one I proposed. Since the other drugs have been so designated, protease inhibitors have been introduced as treatments for AIDS, and the incidence of AIDS wasting has dramatically declined. Nevertheless, there are still some patients who suffer from AIDS wasting that is not sufficiently treated with current medications. These patients need new medications, perhaps such as marijuana that may be more effective in some patients than current medications.
I fail to understand how MAPS' application can be rejected while the other applications have been accepted. I look forward to working with your office to resolve this matter.
Public Policy Ph.D. candidate, Harvard's Kennedy School of Government