Right to Try Clarification Act

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.

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1825 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 1825

  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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 28, 2023

 Mr. Blumenauer (for himself, Ms. Mace, Ms. Dean of Pennsylvania, Mr. 
    Biggs, and Mr. Correa) introduced the following bill; which was 
 referred to the Committee on Energy and Commerce, and in addition to 
    the Committee on the Judiciary, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
  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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Right to Try Clarification Act''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) The Trickett Wendler, Frank Mongiello, Jordan McLinn, 
        and Matthew Bellina Right to Try Act of 2017 (Public Law 115-
        176) was enacted in 2018.
            (2) Section 561B of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360bbb-0a), as added by the Act described in 
        paragraph (1) (referred to in this section as the ``Federal 
        Right to Try law''), does not exclude from the application of 
        such law schedule I substances for which a phase I clinical 
        trial has been completed.
            (3) Multiple schedule I drugs have progressed through phase 
        I clinical trials and have been designated by the Food and Drug 
        Administration as breakthrough therapies under section 506 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) 
        because of preliminary clinical evidence indicating that such 
        drugs demonstrate substantial improvement over existing 
        therapies, but eligible patients have not been permitted access 
        to these drugs pursuant to the Federal Right to Try law.

SEC. 3. AMENDMENT TO FEDERAL RIGHT TO TRY LAW.

    Section 561B(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-0a(b)) is amended by inserting ``any provision of the 
Controlled Substances Act (21 U.S.C. 801 et seq.) that prohibits the 
unauthorized use, possession, distribution, dispensation, or 
transportation of an eligible investigational drug,'' before ``and 
parts''.
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