DEA Approves Schedule I Drug for Clinical Trial by Medical Researchers

Ecstasy_monogramThe Drug Enforcement Administration (DEA) recently gave approval to a clinical trial of 3,4-methylenedioxy-methamphetamine (MDMA), the drug more commonly known as “ecstasy” or “Molly.” MDMA has been classified as a Schedule I controlled substance under the Controlled Substances Act (CSA) for about 30 years, which partly means that it has no medical use approved by the Food and Drug Administration (FDA). It can have dangerous side effects when used as a “club drug,” but it has also been the subject of clinical research in the past. Whether the DEA’s decision indicates the possibility of removing the drug from Schedule I some day remains to be seen. The DEA occasionally removes drugs from the CSA schedules when they receive new approvals from the FDA, but it has also refused to reclassify some Schedule I drugs, especially marijuana.

Earlier this year, the DEA approved limited clinical trials of MDMA by a northern California psychiatrist, who wants to study its potential for treating anxiety in cancer patients. MDMA has a highly controversial history. Chemists working for the German pharmaceutical company Merck first synthesized MDMA in 1912 in an effort to develop a drug to promote blood clotting. The drug eventually emerged as the club drug ecstasy in the early 1980s. The U.S. began efforts to criminalize MDMA in 1984 and officially added it to Schedule I in 1988.

MDMA is a Schedule I hallucinogen under federal law, the most highly restricted category. A Schedule I classification means that the government has determined that the drug meets three criteria: a “high potential for abuse,” “no currently accepted medical use” in the U.S., and no guidelines for the safe “use of the drug…under medical supervision.” 21 U.S.C. § 812(b)(1), 21 C.F.R. § 1308.11(d)(11). Texas law places MDMA in Schedule I and Penalty Group 2. Tex. Health & Safety Code § 481.103(a)(1).

The path for MDMA from little-known drug to Schedule I controlled substance took several interesting turns. The DEA placed it in Schedule I in 1985 without going through the usual rulemaking process. 50 Fed. Reg. 23118-19 (May 31, 1985). The agency cited authority given to the Attorney General by the CSA to make an emergency scheduling decision based on an “imminent hazard to the public safety.” 21 U.S.C. § 811(h).

In at least two cases, convictions for possession or distribution of MDMA were reversed on the grounds that the DEA Administrator lacked the authority to take this action. U.S. v. Spain, 825 F.2d 1426 (10th Cir. 1987); U.S. v. Emerson, 846 F.2d 541 (9th Cir. 1988). Another appellate court vacated the administrator’s action, resulting in MDMA’s removal from Schedule I in 1988. Grinspoon v. DEA, 821 F.2d 881 (1st Cir. 1987). About a month later, it placed the drug back in Schedule I, where it has remained to this day. 53 Fed. Reg. 5156-59 (Feb. 22, 1988).

The DEA occasionally reclassifies drugs when the FDA approves them for a new use. It recently proposed removing the opiate drug naloxegal from the schedules after the FDA approved it for certain uses. 79 Fed. Reg. 64349 (Oct. 29, 2014). It has also proposed removing ioflupane from Schedule II. 80 Fed. Reg. 31521 (Jun. 3, 2015). However, it can also add drugs to the schedules, such as when it added the painkiller Tramadol to Schedule IV, 79 Fed. Reg. 37623 (Jul. 2, 2014), and moved hydrocodone from Schedule III to Schedule II, 79 Fed. Reg. 49661 (Aug. 22, 2014).

These blog posts are meant to be illustrative only. Unless expressly stated to the contrary herein, these matters are not the result of any legal work of Michael J. Brown, but are used to communicate a particular point of view. Michael J. Brown does not claim credit for any legal work done by any lawyer or law firm either generally or specifically, with respect to the matters contained in this blog.

Board-certified criminal defense attorney Michael J. Brown defends the rights of people charged with alleged offenses in state and federal courts in west Texas. Contact us online or at (432) 687-5157 today to schedule a confidential consultation with an experienced and knowledgeable advocate for criminal defendants’ rights.

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Photo credit: Drug Enforcement Administration [Public domain], via Wikimedia Commons.