Mr. Peter Vaccari
FDA Office of Orphan Products Development (HF-35)
5600 Fishers Lane
Rockville, MD 20857

Dear Mr. Vaccari,

Enclosed are two copies of an application from MAPS requesting that marijuana in the treatment of HIV-associated wasting syndrome be designated an Orphan Drug. I hope that the application is sufficiently referenced to permit your office to make a determination based on the data provided. If you need any additional information, I would appreciate the opportunity to try to provide it. I am also available to come to your office if it would be important to meet in person.

MAPS has been working with Dr. Donald Abrams, UC San Francisco, for almost five years to catalyze research into the medical use of marijuana in the treatment of HIV-associated wasting syndrome. Dr. Abrams will be submitting a grant application to NIDA before May 1 for a Phase 1 study of the use of smoked marijuana in the treatment of HIV-associated wasting syndrome. This grant application was prepared with financial support from MAPS. As a result of the recent NIH/NIDA Workshop on the Medical Utility of Marijuana, we are optimistic that this research project will be initiated in the near future.

Thank you very much for the helpful information you have given me regarding the preparation of this request for Orphan Drug designation. The professional manner in which the FDA has treated the issue of the medical use of marijuana deserves to be a model for the rest of the federal government.

Respectfully yours,

[signature]

Rick Doblin,
MAPS President