November 10, 1998
FDA Office of Orphan Product Development (HF-35)
5600 Fishers Lane
Rockville, MD 20857
Dear Ms. Donahoe,
We spoke two weeks ago regarding the status of MAPS' most recent submission, dated June 5, 1998, requesting Orphan Drug designation for marijuana for the treatment of AIDS wasting. At that time, you indicated that the review was still in process and that another month or two would be required. This seems like an inordinately long time to wait. However, I can understand the problems caused by understaffing.
Though I know that your review is based on the merits of the application and not on political concerns, I'm writing to bring to the attention of your office the results of medical marijuana initiatives that were on the ballot this November 3 in Alaska, Washington State, Oregon, Nevada, Arizona, Colorado, and Washington, D.C.
Medical marijuana ballot initiatives passed with strong support in Alaska, Washington State, Oregon, Nevada and Arizona. In Colorado, the measure was on the ballot and passed but it will not go into effect for reasons that are now being litigated. In Washington, D.C., a measure was on the ballot and exit polls indicated that it won by an overwhelming margin. The actual vote count has not yet been released due to a last-minute addition to the D.C. Appropriations Bill, submitted by Rep. Bob Barr (R-GA), which forbade the use of district monies for the certification of the medical marijuana vote. This marks the first time in the history of the United States that the results of an American election are being kept from the people on orders from the Congress. Litigation currently underway is likely to result in the certification of the election results.
The reason I am bringing the results of the medical marijuana initiatives to the attention of your Office is to emphasize that the issue of the medical use of marijuana is being decided at the ballot box and not through FDA-approved scientific research. For many reasons, the process for conducting FDA-approved research into the risks and benefits of the medical use of marijuana is perceived by voters as being politically blocked.
From my perspective, it is a very serious mistake for our society to resolve the medical marijuana issue at the ballot box instead of through FDA-approved research. A decision by your office to designate marijuana an Orphan Drug for the treatment of AIDS wasting would send the right message that science, and not politics, is driving the review of this issue at the Federal level. I say this in the belief that the application MAPS submitted requesting Orphan Drug designation for marijuana for AIDS wasting fulfills all of the necessary requirements for such designation. If your office determines that the application falls short in some manner or another, I urge you to offer advice on how a revised application can indeed be made to comply. Since several other drugs have already been designated by your office as Orphan Drugs for the treatment of AIDS wasting, though using slightly different definitions than the one MAPS proposed, there must be some way for marijuana to obtain the same designation.
I look forward to hearing from you at your earliest convenience regarding MAPS' June 5, 1998 application to have marijuana declared an Orphan Drug for the treatment of AIDS wasting.
Public Policy Ph.D. candidate, Harvard's Kennedy School of Government