Create a Right to Try pathway for patients with life-threatening or severely debilitating conditions to access individualized, one-patient therapies not eligible for FDA approval under the current regulatory system.

Right to Try 2.0 ... would provide access to individualized, rare disease and one-patient therapies

Johnson promoted Right to Try 2.0 as legislation that would create access to individualized patient-specific treatments when current FDA pathways do not accommodate them.

Sen. Johnson Introduces Right to Try for Individualized Treatments Act
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FDA says Right to Try is for patients diagnosed with life-threatening diseases or conditions who have exhausted approved treatment options and cannot participate in a clinical trial. Eligible drugs must have completed Phase 1, be unapproved for any use, have an FDA application filed or be in a clinical trial intended to support approval, and be in active development. FDA says sponsors are not required to provide access.

The existing federal Right to Try pathway only partially matches the commitment: it covers life-threatening disease access to certain investigational drugs, but it does not cover severely debilitating conditions generally or individualized one-patient therapies outside the FDA approval/IND development track.

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FDA: Right to Try
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Public Law 115-176 amended the Federal Food, Drug, and Cosmetic Act to create section 561B for investigational drugs used by eligible patients. It defines eligible patients as having life-threatening disease or condition, exhausted approved options, and being unable to participate in a clinical trial. Eligible investigational drugs must have completed Phase 1 and either have an application filed or be under investigation in a clinical trial intended to support approval/licensure.

The enacted federal law created a Right to Try pathway, but its text ties access to investigational drugs in active approval-oriented development, so it does not fully deliver the claimed individualized one-patient therapy pathway for products not eligible for FDA approval under the current system.

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Public Law 115-176: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
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FDA reports Right to Try Act use for 2018-2022, 2023, and 2024. The table lists 12 eligible drugs or biological products for 2018-2022, 4 for 2023, and 5 for 2024 in the category where clinical outcomes data were not used in review of a marketing application.

FDA reporting shows the existing Right to Try system has continued operating into Johnson's current Senate service, but the report concerns eligible investigational drugs/biologics under the 2018 Act, not a new individualized one-patient pathway.

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FDA: Right to Try Annual Reporting Summary
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The Washington Post reported that, during a dispute over FDA pressure on Sarepta Therapeutics to pause gene-therapy shipments, Sen. Ron Johnson said he relayed concerns to HHS Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, and President Trump. Johnson called it a right-to-try issue and said families were willing to assume the risks of these therapies.

This is concrete advocacy by Johnson in his current term on a right-to-try-related access dispute, but it was not creation of the promised statutory or regulatory pathway for individualized one-patient therapies.

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The Washington Post: What the ouster of a top FDA regulator shows about Trump world divisions
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