Opinion ID: 494127
Heading Depth: 2
Heading Rank: 2

Heading: Impact Of Scheduling On Research.

Text: 71 Dr. Grinspoon also takes issue with the Administrator's alleged failure to consider evidence tending to show that placement of MDMA in Schedule I would strongly discourage medical research on the drug. Grinspoon contends that failure to consider the impact of a scheduling decision on legitimate research amounts to arbitrary and capricious action on the part of the Administrator because he did not weigh all relevant factors in making his decision. Motor Vehicle Manufacturers Association v. State Farm Mutual Insurance Co., 463 U.S. 29, 42-43, 103 S.Ct. 2856, 2866, 77 L.Ed.2d 443 (1983). To buttress his contention, Grinspoon recites a litany of legal, administrative, and practical obstacles that hinder researchers seeking to conduct experiments with Schedule I drugs. These obstacles include mandatory FDA approval of research involving Schedule I substances, 21 C.F.R. Sec. 1301.42(a)-(c); mandatory special registration with the DEA, 21 C.F.R. Secs. 1301.33, 1301.42; mandatory reporting and security procedures beyond those required for drugs placed in Schedules II through V; unavoidable bureaucratic delays; and other adverse impacts due to the grave concern caused by a substance's placement in Schedule I, such as difficulty in obtaining volunteers for clinical studies and, for academic researchers, difficulty in securing approval from institutional review boards. 72 Again, we do not doubt that Dr. Grinspoon has correctly identified several ways in which the placement of MDMA in Schedule I will impede his research and the efforts of other researchers interested in exploring the possibility of clinical uses for MDMA. We must conclude, nevertheless, that the existence of such hurdles does not render the Administrator's scheduling decision arbitrary and capricious. First, it is simply untrue that the Administrator failed to consider the impact on medical research that would be caused by a decision to place MDMA in Schedule I. In the final rule, the Administrator states explicitly that he read with interest the comments from various parties in the record concerning the effect placement of MDMA into Schedule I would have on legitimate research into the substance. 51 Fed.Reg. 36,559 (1986). After several paragraphs discussing the contours of the additional Schedule I controls, the Administrator concludes that those who wish to conduct research with MDMA have available avenues by which to pursue such research. Id. 73 Second, and more importantly, Dr. Grinspoon has identified nothing in the CSA, its legislative history, or its implementing regulations that can be read to require the Administrator to consider the impact of a scheduling determination upon legitimate scientific research. From our review of the CSA, we can only conclude that Congress has already weighed the costs and benefits of legitimate research on dangerous drugs and has determined, in a categorical manner, that if the three Schedule I criteria are satisfied, see 21 U.S.C. Sec. 812(b)(1), then the substance should be subject to Schedule I controls even if this action will create administrative and other burdens for researchers. Here there is no dispute that the Administrator considered all of the section 812(b)(1) criteria in arriving at his final rule, so we are left with a situation in which there can be no complaint that the Administrator failed to consider any relevant factor. 74