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House Co-Sponsorship Memoranda
House of Representatives
Session of 2021 - 2022
Regular Session
MEMORANDUM
| Posted: | July 19, 2022 11:39 AM |
|---|---|
| From: | Representative Tracy Pennycuick |
| To: | All House members |
| Subject: | Immunity protection for the manufacturing of controlled substances for approved federal drug trials |
| Soon, I will be introducing legislation to amend the Administrative Code to provide state level immunity protection for persons who manufacture controlled substances pursuant to an approved federal drug trial. Total U.S. Federal and State government spending on traditional research and treatment for mental health and substance abuse likely exceeded $1 trillion from 2010-2019, but this did not stop the annual deaths of despair (including suicide, alcohol, and drug-related deaths) from climbing by more than 50 percent during the same period, from around 94,000 per year to almost 150,000 per year. That is 150 more deaths of despair every day. Our veterans have been particularly burdened by the ongoing mental health crisis, with the nationwide suicide rate of veterans 1.5 times that of non-veteran adults, and an estimated 20 veterans every day dying by suicide. A growing body of research provides a reason for hope that psilocybin, administered in a controlled setting, will be the most effective tool at our disposal to combat the suicide, opioid, and overall mental health crisis burdening the Commonwealth. Indeed, studies conducted by world renowned medical institutions indicate that psilocybin has shown efficacy, tolerability, and safety in the treatment of conditions including but not limited to addiction, depression, anxiety disorders, and end-of-life psychological distress. The United States Food and Drug Administration, based on the success of these studies, has granted a “Breakthrough Therapy” designation for use of psilocybin to treat depression, meaning it demonstrates substantial improvement over available treatments. Recently, the Drug Enforcement Administration (DEA) has sought applicants for licenses for persons seeking to manufacture psilocybin for research purposes. Under this license, persons will be able to legally manufacture and possess psilocybin, which is currently a Schedule I controlled substance under both federal and state law. Obtaining this DEA license is a critical step towards hosting clinical trials for psilocybin-assisted therapy. It is imperative that any entities wishing to obtain one of these DEA licenses for psilocybin research be protected not only under federal law but also state law. My legislation will provide state-level immunity protection for entities that possess one of these DEA licenses to ensure that clinical trials for psilocybin can take place within the Commonwealth under the confines of federal clinical trials. My legislation will authorize an entity with a DEA license to submit certain information to the Department of Health for publication in the Pennsylvania Bulletin. Provided the entity remains in compliance with the terms of the DEA license, the entity shall not be in violation of our state drug laws for manufacturing a Schedule I or II controlled substance under the auspices of a federal clinical trial. It is important that the Commonwealth allow this type of research to occur while at the same time protecting the health and safety of its citizens. Research into alternative forms of therapy is crucial for advanced mental health and substance abuse treatment. Please join me in co-sponsoring this important piece of legislation. |
Introduced as HB2773