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S 4698

A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize the use of investigational individualized medical treatments by patients diagnosed with a life-threatening disease or condition or severely debilitating illness, and for other purposes.

119th Congress Introduced by Ron Johnson and 1 co-sponsor

Authorize access to investigational, individualized treatments for patients with life-threatening or severely debilitating illnesses when no effective approved options exist.

Introduced in Senate
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Bill Summary · S 4698

Overview

S. 4698 is a bill introduced in the U.S. Senate during the 119th Congress. The primary aim is to amend the Federal Food, Drug, and Cosmetic Act to authorize the use of investigational individualized medical treatments by patients who have a life-threatening disease or condition, or a severely debilitating illness, and to provide for related purposes. The bill has two stated co-sponsors: Senator Tommy Tuberville and Senator Ron Johnson. As of the latest action, the measure was read twice and referred to the Senate Committee on Health, Education, Labor, and Pensions on June 8, 2026; it has not yet progressed to further committee action.

Purpose and Intent

  • Authorize access to investigational, individualized medical treatments for eligible patients.
  • Target patients with life-threatening diseases or conditions or with severely debilitating illnesses who have limited or no satisfactory approved treatment options.
  • Facilitate the use of therapies that are not yet approved by the FDA but are individualized to the patient’s specific medical needs.

Key Provisions and Changes (as described in the title and summary)

  • Amends the Federal Food, Drug, and Cosmetic Act to create a framework for utilization of investigational, individualized treatments.
  • Establishes criteria and processes to determine patient eligibility for access to these treatments.
  • Provides for regulatory, safety, and oversight measures to accompany the use of such treatments, aiming to balance expedited access with patient protection.
  • May include provisions related to informed consent, physician responsibilities, and the involvement of healthcare facilities in the provision of investigational therapies.
  • Addresses the potential interplay with existing FDA programs, such as expanded access (compassionate use) and investigational new drug (IND) pathways, by creating a pathway specifically for individualized therapies.

Note: The summary above reflects core themes implied by the bill’s title and introductory action. The precise statutory text would define the exact eligibility criteria, safeguards, reporting requirements, sponsor responsibilities, and enforcement mechanisms.

Who Would Be Affected

  • Patients diagnosed with life-threatening diseases or severely debilitating illnesses who lack effective approved treatments and seek access to personalized investigational therapies.
  • Healthcare providers (physicians and specialists) who would administer such investigational, individualized treatments.
  • Medical facilities and clinical centers that participate in delivering or coordinating access to investigational therapies.
  • Potentially, sponsors or developers of investigational treatments, including researchers and manufacturers, depending on how the bill assigns responsibilities and oversight.

Procedural and Timeline Aspects

  • Introduced in the Senate and assigned to the Senate Committee on Health, Education, Labor, and Pensions.
  • Action thus far: Read twice and referred to the committee on June 8, 2026.
  • Next potential steps (if the bill advances): committee consideration, possible amendments, floor debate, and votes in the Senate; if passed, it would move to the House of Representatives for consideration, and ultimately to the President for signature or veto.
  • The bill’s effective date, implementation timeline, and any regulatory rulemaking reference would be specified in the full text.

Potential Impacts to Monitor

  • Access: Could expand rapid access to individualized, potentially life-saving therapies for patients with few alternatives.
  • Safety and Oversight: Legislative text typically includes safeguards to protect patients and ensure appropriate use of investigational treatments; monitoring and reporting requirements would shape accountability.
  • Innovation and Medical Practice: May affect clinician decision-making, patient autonomy, and the pace of innovation in personalized medicine.
  • Equity and Access: Depending on cost sharing, insurance coverage, and facility capacity, there could be implications for which patients can access these treatments.

If you’d like, I can pull the bill’s full text or pending committee materials to provide a more detailed section-by-section breakdown of eligibility criteria, safeguards, and administrative processes.

Compiled from official sources — confirm details with the bill’s official record.

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