FDA Approves Clinical Trials of Schedule I Controlled Substance

The federal Controlled Substances Act (CSA) defines five schedules of controlled substances and prescribes penalties for their production, distribution, and possession. Texas drug crime laws contain similar schedules. The CSA includes a list of substances in each schedule, but it also gives some authority to the Department of Justice (DOJ) to modify or adjust the schedules. The DOJ has delegated this authority to the Drug Enforcement Administration (DEA). One factor considered in the scheduling of controlled substances involves the potential for medical use. A different federal agency, the U.S. Food and Drug Administration (FDA), deals with drugs used for medical purposes. Recently, the FDA announced that it will allow further research into the medical potential of a Schedule I controlled substance known as MDMA. While this research could lead to FDA approval of MDMA for medical purposes, the DEA or Congress would still have to remove it from Schedule I.

The CSA places the most highly restricted controlled substances in Schedule I. MDMA, scientifically known as 3,4-methylenedioxymethamphetamine and colloquially known as ecstasy, among other names, was not among the drugs originally added to Schedule I by Congress. The DEA designated MDMA as a Schedule I “hallucinogenic substance” in the 1980s. 21 C.F.R. § 1308.11(d)(11). Texas places MDMA in Penalty Group 2. Tex. Health & Safety Code § 481.103(a)(1).

The CSA’s criteria for inclusion in Schedule I are “high potential for abuse,” a lack of “currently accepted medical use,” and “a lack of accepted safety for use…under medical supervision.” 8 U.S.C. § 812(b)(1). Other well-known Schedule I controlled substances include heroin, lysergic acid diethylamide (LSD), and marijuana. Id. at §§ 812(c)(I)(b)(10), (c)(9), (c)(10). Many controlled substances commonly associated with the illegal drug trade are actually listed in Schedule II, including cocaine and methamphetamine. Id. at § 812(c)(II)(a)(4), 21 C.F.R. § 1308.12(d)(2).

The CSA prohibits “manufactur[ing], distribut[ing], or dispens[ing]” a controlled substance, or possessing a controlled substance with the intent to do any of these acts. 21 U.S.C. § 841(a)(1). A violation of the CSA involving MDMA can result in up to 20 years in prison and a fine of up to $1 million. Id. at § 841(b)(1)(C). In Texas, “knowingly manufactur[ing], deliver[ing], or possess[ing] with intent to deliver” MDMA ranges from a state jail felony for amounts of less than one gram to an offense carrying a life sentence for amounts of at least 400 grams. Tex. Health & Safety Code § 481.113.

In late August 2017, the FDA announced that it has granted a “breakthrough therapy” designation to MDMA for post-traumatic stress disorder (PTSD) treatment. This means that the FDA has concluded that MDMA could “demonstrate substantial improvement over existing therapies” for PTSD. 21 U.S.C. § 356(a)(1). It allows researchers to pursue funding for clinical trials, but it does not guarantee final approval by the FDA. It also does nothing to change MDMA’s Schedule I status under DEA regulations.

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 drug crime attorney Michael J. Brown has practiced in West Texas for over two decades, defending people charged with alleged state and federal offenses. To schedule a confidential consultation with a knowledgeable and experienced advocate for criminal justice, contact us today online or at (432) 687-5157.

More Blog Posts:

DEA Considers Banning Plant Used in Pain Management, Citing Public Safety Concerns, Texas Criminal Lawyer Blog, January 25, 2017

DEA Approves Schedule I Drug for Clinical Trial by Medical Researchers, Texas Criminal Lawyer Blog, July 29, 2015

Baltimore Protests Raise Questions About Excessive Bail, Eighth Amendment Protections, Texas Criminal Lawyer Blog, May 4, 2015


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