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
primary · press_release · model gpt-5.5

legacy_unverified · Source version not recorded · locator unknown

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.

Unverified model/legacy excerpt; not proof. AI summary (separate from source): 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.

partial unknown

FDA: Right to Try
secondary · model gpt-5.5 · confidence 91%

legacy_unverified · Source version not recorded · locator unknown

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.

Unverified model/legacy excerpt; not proof. AI summary (separate from source): 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.

partial unknown A for effort

Public Law 115-176: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
secondary · model gpt-5.5 · confidence 90%

legacy_unverified · Source version not recorded · locator unknown

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.

Unverified model/legacy excerpt; not proof. AI summary (separate from source): 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.

partial same_term

FDA: Right to Try Annual Reporting Summary
secondary · model gpt-5.5 · confidence 86%

legacy_unverified · Source version not recorded · locator unknown

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.

Unverified model/legacy excerpt; not proof. AI summary (separate from source): 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.

unresolved same_term A for effort

The Washington Post: What the ouster of a top FDA regulator shows about Trump world divisions
secondary · model gpt-5.5 · confidence 78%