S.Amdt. 6636

SA 6636, submitted by Mr. Johnson, aims to change the Federal Food, Drug, and Cosmetic Act to allow patients with life-threatening diseases, conditions, or severely debilitating illnesses to use investigational individualized medical treatments.

The amendment adds the following to the bill:

• New Definitions: It defines investigational individualized medical treatment as a biological product or drug based on a patient's unique genomic profile (such as DNA, genes, or metabolites). It also defines eligible health care facility as one operating under Federal assurance for the protection of human subjects.

• Patient Eligibility: It establishes that a patient is eligible for these individualized treatments if they have a life-threatening or severely debilitating condition, have considered approved treatment options, and have provided additional informed consent. This consent must be written and witnessed, explaining approved treatments and the potential outcomes of the proposed individualized treatment.

• Physician Requirements: A physician must certify the patient's condition and be in good standing with their licensing board. The physician cannot be paid by the drug manufacturer for this certification.

• Manufacturer and Facility Rules: Manufacturers operating within an eligible health care facility and following Federal assurance laws may make these treatments available. However, manufacturers are not required to provide the treatment to any patient.