Us Congress 2023-2024 Regular Session

Us Congress House Bill HB1393

Introduced
3/7/23  
Refer
3/7/23  

Caption

To amend the Controlled Substances Act to define currently accepted medical use with severe restrictions, and for other purposes.

Impact

This bill will modify existing federal drug laws by creating clearer pathways for the approval and usage of drugs deemed as breakthrough therapies. This approach could facilitate faster access to medications that may be beneficial for serious or life-threatening conditions when no satisfactory alternatives exist. Supporters argue that this could significantly improve patient care and treatment outcomes, particularly for those suffering from severe illnesses. However, such modifications also come with the challenge of ensuring that proper safety and efficacy measures remain intact during the drug approval process.

Summary

House Bill 1393 aims to amend the Controlled Substances Act by defining 'currently accepted medical use with severe restrictions' for certain drugs and substances. The bill specifies that a drug or substance can be classified as having currently accepted medical use under strict conditions, particularly relating to its designation as a breakthrough therapy or its authorization for expanded access by the Secretary of Health and Human Services. These changes intend to streamline the classification of drugs that offer potential therapeutic benefits under specific regulatory frameworks.

Contention

Notably, opposition to the bill may arise from concerns about the broader implications of loosening restrictions on controlled substances. Critics might argue that, while aimed at improving patient access to potentially life-saving drugs, the changes could also lead to misuse or inappropriate distribution of substances that currently have strict regulations. There is a delicate balance between facilitating medical use and maintaining control over potentially harmful drugs, making this a point of contention in discussions surrounding HB 1393.

Companion Bills

US SB689

Related A bill to amend the Controlled Substances Act to define currently accepted medical use with severe restrictions, and for other purposes.

Previously Filed As

US SB689

A bill to amend the Controlled Substances Act to define currently accepted medical use with severe restrictions, and for other purposes.

US HB4490

To amend the Controlled Substances Act to authorize pharmacies to deliver certain controlled substances to an administering practitioner in lieu of delivering such substances to the ultimate user, and for other purposes.

US HB171

Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act This bill places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act. Additionally, the bill establishes a new, alternative registration process for schedule I research that is funded by the Department of Health and Human Services or the Department of Veterans Affairs or that is conducted under an investigative new drug exemption from the Food and Drug Administration. The bill also makes several other changes to registration requirements for conducting research with controlled substances, including permitting a single registration for related research sites in certain circumstances, waiving the requirement for a new inspection in certain situations, and allowing a registered researcher to perform certain manufacturing activities with small quantities of a substance without obtaining a manufacturing registration.

US HB238

Residential Substance Use Disorder Treatment Act of 2023 This bill revises and reauthorizes through FY2027 grants for residential substance use disorder treatment programs at state and local correctional and detention facilities. Among the revisions, the bill replaces statutory references to substance abuse with substance use disorder, specifies that the term residential substance use disorder treatment program includes a medication-assisted treatment program, requires the chief medical officer or other staff overseeing a program to complete training on the science of addiction and the latest research and clinical guidance on treating substance use disorders in criminal justice settings, and allows people who are awaiting trial or in pretrial detention to participate in the programs.

US HB467

Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act This bill places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act. Additionally, the bill establishes a new, alternative registration process for schedule I research that is funded by the Department of Health and Human Services or the Department of Veterans Affairs or that is conducted under an investigative new drug exemption from the Food and Drug Administration. The bill also makes several other changes to registration requirements for conducting research with controlled substances, including permitting a single registration for related research sites in certain circumstances, waiving the requirement for a new inspection in certain situations, and allowing a registered researcher to perform certain manufacturing activities with small quantities of a substance without obtaining a manufacturing registration.

US SB223

A bill to amend the Controlled Substances Act to fix a technical error in the definitions.

US HB455

This bill makes technical corrections in the definitions section of the Controlled Substances Act.

US SB1844

Animal Drug and Animal Generic Drug User Fee Amendments of 2023 Animal Generic Drug User Fee Amendments of 2023 Animal Drug User Fee Amendments of 2023

US HB3570

Comprehensive Response to Fentanyl-Related Substances and Fentanyl-Laced Substances Act

US HB5866

SAFE in Recovery Act Substance Use Disorder and Family Engagement in Recovery Act

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