A Wake-up Call from Down Under: Australia's Therapeutic Goods Administration Reschedules Psilocybin and MDMA

By Shane Pennington

Mar 1, 2023

Originally posted on On Drugs, which offers "Cutting Edge Thoughts on Drug Regulation by Matt Zorn and Shane Pennington." Subscribe here.

As Matt Zorn discussed here and in this opinion piece with Chris Koddermann, Australia’s Therapeutic Goods Administration (TGA) recently approved a request to reschedule psilocybin and MDMA under that country’s drug classification scheme, making Australia the first country in the world to recognize the psychedelic drugs as medicines. Effective July 1, 2023, the TGA will add psilocybin and MDMA to Schedule 8 of Australia’s list of Controlled Drugs, permitting qualified psychiatrists to prescribe MDMA to treat post-traumatic stress disorder and psilocybin for treatment-resistant depression. 

Access will be limited at first, but still—this is big news. For starters, rescheduling will make it easier for scientists in Australia to research these promising treatments. Further, Australia’s unexpected decision appears to be a regulatory first. Aside from medical cannabis, no country has rescheduled such a restricted compound before approving it for marketing—that is, before drug companies are permitted to profit from it.

I’m working on another piece that will address various criticisms of the TGA’s decision. My purpose here is to underscore how the TGA’s decision provides an especially dramatic illustration of the tragic consequences the DEA’s unlawful, anti-science approach to drug control has here at home.

To support its decision, the TGA relied heavily on studies conducted in the U.S. and recent U.S. Food and Drug Administration (FDA) decisions recognizing psilocybin and MDMA’s extraordinary therapeutic potential. Around the same time, the DEA shot down a petition—based on those same arguments and evidence—that Matt and I submitted on behalf of a palliative-care doctor, requesting rescheduling of psilocybin under U.S. law. The DEA’s four-sentence analysis completely ignored the same studies and FDA decisions that persuaded the Australian regulator to reschedule.  

The dramatically different fates of these similar petitions reveal a troubling reality about U.S. drug law: Under the DEA’s watch, the scientific and medical determinations of the nation’s leading public health agency carry considerable weight around the world but are often ignored at home. That revelation should terrify anyone interested in rational, evidence-driven drug policy. 

Those committed to the rule of law should be alarmed, too. Unlike Australia, which is under no obligation to consider the FDA’s views when making its own scheduling decisions, the DEA is obligated by statute to seek out the FDA’s expert judgment before taking action on a rescheduling petition. (See 21 U.S.C. 811(b) (requiring DEA to request a medical and scientific evaluation and scheduling recommendation from FDA, prohibiting DEA from diluting FDA’s scheduling recommendation, and making FDA’s recommendations binding on DEA with respect to scientific and medical questions)) In other words, Congress made the FDA’s views on scientific and medical issues binding on DEA. Thus, the DEA’s refusal to acknowledge—much less follow—FDA’s scientific and medical judgments in the scheduling context is unlawful and inexcusable

Matt and I submitted that rescheduling petition on behalf of Dr. Sunil Aggarwal. Dr. Aggarwal has spent years seeking access to psilocybin to treat terminally ill cancer patients who suffer from debilitating depression that does not respond to any approved drugs on the market. His patients are out of options, and they are running out of time. The DEA’s flip rejection of Dr. Aggarwal’s petition likely deprives his patients of a promising treatment that their physician, the FDA, and, most importantly, they themselves believe should be available to them.

Dr. Aggarwal has challenged the DEA’s decision in the U.S. Court of Appeals for the Ninth Circuit. He hopes (and deserves) to prevail. Yet, whichever way the Ninth Circuit rules, the deeper problem—having a law-enforcement agency like the DEA in charge of the scheduling process—will remain. 

Since that’s a problem Congress created, Congress should take action to address it. Passing the Breakthrough Therapies Act—a bipartisan bill introduced by Senators Booker and Paul that would require the DEA to move any schedule I substance granted breakthrough therapy status by the FDA to schedule II—would be a good start. 

Next, it could take the problem head-on by stripping the DEA of its authority over scheduling. Among other things, this would ensure that Americans benefit from the FDA’s scientific and medical expertise at least as much as Australians. 

Finally, Congress should consider jettisoning schedule I altogether. As Matt has explained in greater detail, there are only two practical differences between schedules I and II under the Controlled Substances Act (CSA). First, schedule II substances may be made available for prescription, whereas schedule I substances may not. Second, schedule I substances are subject to research restrictions that don’t apply to substances in any other schedule. 

If decades of experience under the CSA have taught us anything, it is that drug policy should promote—not deter—science and research. This is especially true when it comes to unapproved-but-widely-used drugs like psilocybin, MDMA, cannabis, etc. Schedule I is anti-science. It delays—and sometimes blocks outright—access to lifesaving therapies. Even accepting the DEA’s ridiculous definitions of “abuse” and “diversion” (basically any use whatsoever outside of heavily regulated government-approved research), schedule I does virtually nothing that schedule II doesn’t already do to prevent either. In other words, it does a ton of harm and has no countervailing benefits—the very essence of bad policy.

We know schedule I is causing real and completely preventable harm to untold numbers of innocent people. How long will we continue to let them suffer?

The content and links provided on this page are for informational purposes only and not for the purpose of providing legal or tax advice. Viewing this page does not establish an attorney-client relationship. You should consult with a qualified legal professional for advice regarding any particular issue or problem. The contents of this page may be considered attorney advertising under certain rules of professional conduct.