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Right to Try Clarification Act
12/15/2023, 3:56 PM
Summary of Bill HR 1825
The Right to Try Clarification Act, also known as Bill 118 hr 1825, is a piece of legislation that aims to clarify and expand upon the existing Right to Try law. The Right to Try law was originally passed in 2018 and allows terminally ill patients to access experimental treatments that have not yet been fully approved by the Food and Drug Administration (FDA).
The Right to Try Clarification Act seeks to address some of the ambiguities and limitations of the original law. One key provision of the bill is to clarify that manufacturers of experimental treatments are not required to report adverse events to the FDA unless they are already required to do so under existing regulations. This is intended to reduce the burden on manufacturers and streamline the process of providing access to experimental treatments for patients.
Additionally, the bill includes provisions to protect healthcare providers who prescribe experimental treatments in good faith from liability, as well as provisions to ensure that patients are fully informed about the risks and benefits of the treatments they are receiving. Overall, the Right to Try Clarification Act aims to make it easier for terminally ill patients to access potentially life-saving experimental treatments while also providing important protections for patients, healthcare providers, and manufacturers.
The Right to Try Clarification Act seeks to address some of the ambiguities and limitations of the original law. One key provision of the bill is to clarify that manufacturers of experimental treatments are not required to report adverse events to the FDA unless they are already required to do so under existing regulations. This is intended to reduce the burden on manufacturers and streamline the process of providing access to experimental treatments for patients.
Additionally, the bill includes provisions to protect healthcare providers who prescribe experimental treatments in good faith from liability, as well as provisions to ensure that patients are fully informed about the risks and benefits of the treatments they are receiving. Overall, the Right to Try Clarification Act aims to make it easier for terminally ill patients to access potentially life-saving experimental treatments while also providing important protections for patients, healthcare providers, and manufacturers.
Congressional Summary of HR 1825
Right to Try Clarification Act
This bill specifies that investigational drugs that are provided via the Right to Try pathway are exempt from restrictions that would otherwise apply under the Controlled Substances Act (e.g., restrictions on the use or possession of schedule I controlled substances).
The Right to Try pathway allows drug manufacturers to provide certain investigational drugs for which a Phase I clinical trial has been completed, but that have not yet received approval from the Food and Drug Administration, directly to individuals who have imminently life-threatening diseases or conditions and who have exhausted other treatment options and are unable to participate in clinical trials.
Current Status of Bill HR 1825
Bill HR 1825 is currently in the status of Bill Introduced since March 28, 2023. Bill HR 1825 was introduced during Congress 118 and was introduced to the House on March 28, 2023. Bill HR 1825's most recent activity was Referred to the Subcommittee on Health. as of April 7, 2023
Bipartisan Support of Bill HR 1825
Total Number of Sponsors
1Democrat Sponsors
1Republican Sponsors
0Unaffiliated Sponsors
0Total Number of Cosponsors
0Democrat Cosponsors
0Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 1825
Primary Policy Focus
HealthComments
Sponsors and Cosponsors of HR 1825
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