October 20, 2003
Ms. Karen Tandy
Administrator
Drug Enforcement Administration
Mailstop: AXS
2401 Jefferson Davis Highway
Alexandria, VA 22301
Dear Ms. Tandy,
We are writing to express our strong support for the application by the University of Massachusetts Amherst for registration as a bulk manufacturer of marijuana for distribution to researchers in clinical investigations authorized by the Food and Drug Administration and non-clinical investigations at DEA-licensed laboratories.
We believe that the National Institute on Drug Abuse facility at the University of Mississippi has an unjustifiable monopoly on the production of marijuana for legitimate medical and research purposes in the United States. Federal law makes clear that the importation and bulk manufacture of Schedule I and II substances must be provided "under adequately competitive conditions." ( U.S.C. 823 (a) (1).) Federal regulations also provide: "In order to provide adequate competition, the Administrator shall not be required to limit the number of manufacturers in any basic class to a number less than that consistent with maintenance of effective controls against diversion solely because a smaller number is capable of producing an adequate and uninterrupted supply." (21 C.F.R. 1301.33 (b).)
Federal law clearly requires adequate competition in the manufacture of Schedule I and II substances. The current lack of such competition may well result in the production of lower-quality research-grade marijuana, which in turn jeopardizes important research into the therapeutic effects of marijuana for patients undergoing chemotherapy or suffering from AIDS, glaucoma, or other diseases.
The University of Massachusetts Amherst is one of the nation's most distinguished research universities, and it is highly qualified to manufacture marijuana for legitimate medical and research purposes with effective controls against diversion. We urge you to grant the university's application for registration as a bulk manufacturer.
With respect and appreciation,
Sincerely,
| Edward M. Kennedy | John F. Kerry |
| U.S. Senator | U.S. Senator |