On May 25, 1999, MAPS successfully secured Orphan Drug Designation for Marijuana in the treatment of AIDS wasting syndrome. Since it is not possible to obtain a patent on marijuana for use as a prescription medicine, an Orphan Drug Designation makes marijuana available for research and development into a prescription medicine. The Orphan Drug Designation program was developed by congress to facilitate the development of rare drugs. In the years since MAPS obtained permission to study this treatment, the advent of protease inhibitors has largely eliminated AIDS wasting syndrome in the US. As a result, we have not pursued this research.
Articles from the MAPS’ Bulletin
SUMMARY: Published in MAPS Bulletin Volume IX Number 3
MAPS Succeeds in Securing an Orphan Drug Designation for Marijuana (1999)
- May 1999: Letter of Approval from FDA for MAPS’ ODD application
- February 1999: MAPS’ fifth amendment in response to the December 1998 rejection
- December 1998: Third letter from FDA rejecting the application/amendments 2-4
- November 1998: Fourth amendment from MAPS to the FDA
- August 1998: Third amendment from MAPS to the FDA
- June 1998: MAPS’ 2nd amendment in reponse to the 2nd FDA rejection
- March 1998: Supporting letter from Dr. Alice Tang
- November 1997: Second letter from FDA rejecting the application
- October 1997: Supporting letter from Dr. Alice Tang
- September 1997: MAPS’ first amendment in reponse to the first rejection
- September 1997: Supporting letter from Dr. Kathleen Mulligan
- September 1997: Supporting letter from Dr. Donald Abrams
- June 1997: First letter from FDA rejecting the application
- April 1997: Letter from FDA acknowledging the application was received
- April 1997: MAPS’ original application to FDA
