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Right to Try Clarification Act

12/29/2022, 6:18 PM

Summary of Bill HR 8440

Bill 117 HR 8440, also known as the Right to Try Clarification Act, 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 ensure that manufacturers of experimental treatments are protected from liability if a patient experiences adverse effects from the treatment. This provision is intended to encourage more manufacturers to make their experimental treatments available to patients under the Right to Try law.

Additionally, the bill clarifies that the FDA cannot use data from patients who access experimental treatments under the Right to Try law to delay or deny approval of the treatment. This provision is meant to ensure that patients who choose to access experimental treatments are not penalized for doing so. Overall, the Right to Try Clarification Act aims to strengthen and expand the existing Right to Try law, providing terminally ill patients with more options for accessing potentially life-saving treatments. The bill has received bipartisan support in Congress and is currently under consideration for passage.

Congressional Summary of HR 8440

Right to Try Clarification Act

This bill specifies that investigational drugs that are provided directly to individuals from manufacturers without the need for federal regulatory approval (i.e., 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).

Current Status of Bill HR 8440

Bill HR 8440 is currently in the status of Bill Introduced since July 20, 2022. Bill HR 8440 was introduced during Congress 117 and was introduced to the House on July 20, 2022.  Bill HR 8440's most recent activity was Referred to the Subcommittee on Crime, Terrorism, and Homeland Security. as of November 1, 2022

Bipartisan Support of Bill HR 8440

Total Number of Sponsors
1
Democrat Sponsors
1
Republican Sponsors
0
Unaffiliated Sponsors
0
Total Number of Cosponsors
10
Democrat Cosponsors
6
Republican Cosponsors
4
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 8440

Primary Policy Focus

Health

Alternate Title(s) of Bill HR 8440

Right to Try Clarification Act
Right to Try Clarification Act
To clarify that the Federal Right to Try law applies to schedule I substances for which a phase I clinical trial has been completed and to provide access for eligible patients to such substances pursuant to the Federal Right to Try law.

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