arrow_back Civic Audit
Share share

Faster Access to Experimental Drugs: New Definition for Medical Use of Controlled Substances.

This bill amends the Controlled Substances Act to define 'currently accepted medical use with severe restrictions.' This definition applies to experimental drugs designated as 'breakthrough therapies' or authorized for 'expanded access' for patients with serious or life-threatening diseases. The change allows these substances to be moved more quickly from the highly restricted Schedule I to Schedule II, potentially accelerating patient access to promising, yet unapproved, treatments.
Key points
Easier access to experimental drugs: Active ingredients in drugs designated as 'breakthrough therapy' or authorized for 'expanded access' can be moved faster from Schedule I (most restrictive) to Schedule II of controlled substances.
New Definition: Introduction of the term 'currently accepted medical use with severe restrictions' into the Controlled Substances Act.
Expedited Procedures: Authorities (Attorney General) must act quickly (within 90 days) to reclassify a substance upon receiving notification from the Secretary of Health and Human Services regarding the drug's status.
article Official text account_balance Process page notifications_active Track this Bill
gavel
Status:
Expired
Record your position for audit.
Why does your vote on bills matter?
It creates raw, undeniable proof. Civic Will provides the permanent data to verify the Government's loyalty towards its citizens (explained here). Start recording it now.
Additional Information
Print number: 118_S_689
Sponsor: Sen. Booker, Cory A. [D-NJ]
Process start date: 2023-03-07