The 101 of the Bipartisan Breakthrough Therapy Act

The 101 of the Bipartisan Breakthrough Therapy Act

Seraiah Alexander
Seraiah Alexander
December 28, 2022
4 min

Psilocybin has been used medicinally for centuries, yet it is still considered a Schedule I drug by the Drug Enforcement Agency (DEA). More recent clinical studies have found that psilocybin can significantly reduce symptoms and treat several psychological conditions, such as major depressive disorder and PTSD (1)Facilitated psilocybin services to treat these conditions are currently only legal in Oregon and Colorado.

Otherwise, psilocybin is federally illegal, which makes it inaccessible as a treatment option for those struggling with severe mental illnesses. As we gain more knowledge on the benefits of psychedelics as treatment, there is hope in moving towards a direction of federally legal treatment options. Despite its illegal status, since the U.S. Food and Drug Administration (FDA) recognizes psilocybin as a breakthrough therapy, it could lead to the legalization of the drug as a medicine.

About the Breakthrough Therapy Act

In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act. This act allows the FDA to prioritize a drug’s development if it has shown significant progress in clinical trials for treating life-threatening conditions. Drugs and vaccines that provide clinical benefits to those suffering from severe conditions are viewed as breakthrough therapy because they perform more effectively than any other drugs available to the public.

The FDA will approve new drug applications based on whether treatments are more effective than other available therapies on the market or have clinically significant endpoints that show substantial improvement in treating life-threatening diseases.

Different processes are used to expedite the availability of drug treatments for serious conditions. When a drug is up for Priority Review designation, it will be decided upon by the FDA within six months. A drug qualifies for the Accelerated Approval pathway when it fills an unmet medical need for a serious condition based on the evidence from clinical studies called surrogate endpoints (2)

Fast Track designation begins clinical development for a new drug and accelerates the approval process to treat urgent medical needs. Drugs designated in the fast track category can face rolling review, which allows drug manufacturers to submit sections of their approval application based on preclinical data instead of all of the clinical data at once.

The process of expediting FDA Breakthrough Therapy designation is similar to the Fast Track process, yet it requires the drugs to have clinical evidence of substantial improvement over preexisting treatments. The investigational new drug receives careful FDA guidance to efficiently develop it to have all the requirements to determine its effectiveness and market eligibility. 

The next steps for the Breakthrough Therapy Act

On average, it takes around seven years for a clinical drug development program to study and approve a drug for public use. When a drug is considered a breakthrough therapy, the length of the development process speeds up so that it can reach those who need it as soon as possible. Although many drugs may demonstrate promising results, only a few get approved as a breakthrough therapy.

From 2013-2019, only 26% of therapeutic drugs received FDA approval for breakthrough therapy; however, as of 2022, drug approval rates have gone up to 40% (3). Even so, many drugs with preliminary clinical evidence to support their effectiveness are not accepted because breakthrough status can be challenging. They must meet regulatory standards that fit the guidelines of the Center for Drug Evaluation and Research (CDER) to protect the public’s health from the release of dangerous or ineffective drugs.

The FDA classified psilocybin to have Breakthrough Therapy designation for treatment-resistant depression in October 2018. Since then, psilocybin has been further studied and proven its treatment efficiency. These results have led to a push in the prioritization of psilocybin research.

On November 17, 2022, U.S. Senators Cory Booker and Rand Paul initiated the Breakthrough Therapies Act, which enables the DEA to change Schedule I drug substances to Schedule II if they meet breakthrough therapy requirements (4).

This means that psychedelic drugs like MDMA and psilocybin can be reclassified under the Controlled Substances Act because of their promising treatment of severe mental health conditions such as suicidal depression, PTSD, and substance abuse disorders. If Congress passes this bill, there will be fewer barriers to researching psilocybin-assisted therapy.

Natural medicine and psilocybin

Psilocybin mushrooms are found worldwide and have been used for thousands of years for medicinal, spiritual, and recreational purposes. The medicinal effects of psilocybin became popularized in “western” culture by the late 1950s. Mushrooms held significant importance to indigenous cultures far before westernized discovery.

As a result, we must be mindful of indigenous practices surrounding psychedelic medicine and give credit where it is due to these ancient practices. Indigenous people have been beyond generous in sharing their wisdom surrounding psilocybin treatment, so it is essential not to abuse or commodify the natural medicine and the knowledge of people who have been using it for centuries. 

Sandor Iron Rope, the president of the Native American Church of North Dakota, argues, “The original decriminalization movement started too quickly without securely thinking about the network of interconnected relationships with plants and indigenous communities.” He expresses frustration that politicians now listen to Native Americans since decriminalization has been rolling out, yet they did not recognize Indigenous knowledge in the past.

Though we finally have the technology for clinical studies that scientifically prove claims of psilocybin effectiveness, the medicine still comes from the earth, separate from man-made labs. As psilocybin therapy popularizes, we must continue acknowledging the historic and sacred practices we borrow.

Psychedelic drugs like psilocybin have the potential to become normalized within our healthcare system for the treatment of life-threatening psychological illnesses. With this in mind, we should remain conscious of the roots of these practices and the accessibility to treatment in the future.

If Congress approves the Breakthrough Therapy Act, there could be a review of essential drugs waiting to become a treatment for life-threatening conditions. As Schedule I narcotics like psilocybin potentially move down to Schedule II, we can gradually move past the binary mindset of “good” and “bad” drugs to approach different treatments with an open mind.


  1. “Breakthrough Therapy Designation: The Real-World Impact of Structural Novelty.” CAS, https://www.cas.org/resources/cas-insights/drug-discovery/breakthrough-therapy-designation-real-world-impact.
  2. Center for Drug Evaluation and Research. “Surrogate Endpoints.” U.S. Food and Drug Administration, FDA, https://www.fda.gov/drugs/development-resources/surrogate-endpoint-resources-drug-and-biologic-development.
  3. Coppola, Maurizio, et al. “Psilocybin for Treating Psychiatric Disorders: A Psychonaut Legend or a Promising Therapeutic Perspective?” Journal of Xenobiotics, U.S. National Library of Medicine, 7 Feb. 2022, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8883979/.
  4. S.1 - 117th Congress (2021-2022): For The People Act of 2021. https://www.congress.gov/bill/117th-congress/senate-bill/1.

Fact Checked: Shannon Ratliff


Seraiah Alexander

Seraiah Alexander

Content Editor

Table Of Contents

About the Breakthrough Therapy Act
The next steps for the Breakthrough Therapy Act
Natural medicine and psilocybin

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