The Department of Health and Human Services and Petition Related Issues

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Your October 20 letter to Secretary Donna Shalala regarding the Triennial Report to Congress on Drug Abuse and Drug Abuse Research . . .was referred to the Substance Abuse and Mental Health Services Administration (SAMSHA) and referred by SAMSHA to the National Institute on Drug Abuse (NIDA ). . . NIDA absolutely and wholeheartedly understands and supports the need for, and the importance of, providing Congress and others with timely and relevant information on the progress being made on drug abuse and addiction research. Specifically with regard to the Triennial Report . . . we have extended to Congress our sincere apology for the unintentional delay in its issuance. The Department takes most seriously its commitment to honoring the requirement for this legislatively mandated report. This report objectively describes known data and findings which had occurred during the 3 years subsequnt to the period of the last report. We expect that the report should be released in the near future. Robin Kawazoe, Office of Science Policy and Communications, NIDA. HHS March 27, 1996 Response to Inquiry Regarding Triennial Report to Congress on Drug Abuse and Drug Abuse Research. (75 kb .pdf file)

I have been asked to respond to your letter of October 25, 2000 to the General Counsel of the Department of Health and Human Services written on behalf of your clients Jon Gettman and High Times Magazine (Trans-High Corporation). You inquired about the status of their petition regardng the scheduling of marijuana, tetrahydrocannibinols, dronabinol, and nabilone under the Controlled Substances Act (CSA). . . . Once a scheduling request is referred to FDA, FDA’s Center for Drug Evaluation and Research (CDER), with assistance from others within the Agency, conducts a review of the substance. This review includes review of the chemical properties, pharmacology studies, and clinical studies and reports related to the substance. The voluminous petition submitted by Mr. Gettman, coupled with the number of substances at issue, and the complexity of the analysis mandated by the CSA, required a significant amount of time on the part of FDA to ensure that all the factors were being thoroughly considered. The agency’s evaluation is in its final stages. After completion it will be transmitted to the Assistant Secretary of Health who will make the final determination and respond to DEA. In addition, you requested that the petitioner and the public be provided an opportunity to provide evidence for consideration during review . . .I note that the petitioner had the opportunity to submit any evidence he believed to be relevant when he submitted his petition. He appears to availed himself of this opportunity since his petition exceeds 275 pages. In addition, the CSA requires that a rule by DEA that adds a substance to a schedule, transfers a substance to a different schedule, or removes a substance from control must be made on the record after an opportunity for a hearing (see 21 USC 811(a). Furthermore, FDA is not bound to consider only the evidence contained in the petition, but rather considers all relevant evidence in its medical and scientific evaluation. Thus, in developing a medical and scientific evaluation for the substances identified in Mr. Gettman’s petition, the Agency is taking into account studies, reports, and data that have become available since Mr. Gettman filed his petition with the DEA. Margaret Jane Porter, Chief Counsel, Food and Drug Administration. HHS December 22, 2000 Status Report on Rescheduling Petition. (124 kb .pdf file)

Medical and Scientific Evaluations of Record


One of the goals of the present rescheduling petition was to require HHS to update and replace the existing medical and scientific evaluations of record for marijuana and THC. As reported above work on contemporary medical and scientific evaluations of marijuana, tetrahydrocannibinols, dronabinol, and nabilone is in its “final stages”. The existing evaluations for marijuana, THC, and nabilone were compiled in the early 1980’s, well before the discovery of the cannabinoid receptor system in 1988 and well before new conventions were adopted for evaluating the dependence liability of drugs by the scientific community. These existing evaluations were prepared in response to NORML’s 1972 rescheduling petition and several court orders from the US Court of Appeals. (See ACT v. DEA [491 kb .pdf file] for a list of prior court decisions and discussion of the resolution of NORML’s petition.)

The evaluations of abuse potential for THC and Marijuana are based on the following premise: any non-medical use is drug abuse. This approach is consistent with the legislative history of the CSA provisions regarding scheduling factors, specifically with the discussion of the meaning of abuse potential as it pertains to the scheduling statutes. However the scientific community adopted other standards as they learned more about the human brain and dependence liabilities of drugs. These new standards are evident in the OTA report on the Biological Components of Substance Abuse and Addiction, and this is why this report was mentioned so prominently in early correspondence with DEA over these issues. They are also evident in the evaluation of Nabilone, a substance pharmacologically equivalent to THC, conducted a few years after the evaluations of THC and Marijuana.

The prior evaluations of record were acquired by way of a Freedom of Information Act Request filed after the rescheduling petition was prepared and filed.

Tetrahydrocannabinol (THC); August 16, 1982 (1.02 MB .pdf file)

Marijuana Plant Material; May 13, 1983 (2.01 MB .pdf file)

Nabilone; April 25, 1986 (846 kb .pdf file)