Right to Try Clarification Act

Bill: 118-hr-1825
Sponsor: full_name: Rep. Blumenauer, Earl [D-OR-3]
Introduced: 2023-03-28
Policy area: Health
Latest action: action_date: 2023-04-07
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2023-03-28
action_desc: Introduced in House
text: <p><b>Right to Try Clarification Act</b></p> <p>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).</p> <p>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.</p>

tv_txt: I 118th CONGRESS 1st Session H. R. 1825 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.

1. Short title This Act may be cited as the Right to Try Clarification Act . 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. 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 .