AB 1944: Individualized investigational treatment.

Existing law, the federal Food, Drug, and Cosmetic Act, prohibits a person from introducing into interstate commerce any new drug unless the drug has been approved by the United States Food and Drug Administration (FDA). Existing law requires the sponsor of a new drug to submit to the FDA an investigational new drug application and to then conduct a series of clinical trials to establish the safety and efficacy of the drug in human populations and submit the results to the FDA in a new drug application. Existing federal law also regulates biomedical and behavioral research involving human subjects.

Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices and is administered by the State Department of Public Health. A violation of that law is a crime. The Sherman Food, Drug, and Cosmetic Law prohibits, among other things, the sale, delivery, or giving away of a new drug or new device unless either the department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the federal Food, Drug, and Cosmetic Act.

Existing law provides for the licensure and regulation of various healing arts professions and vocations by boards within the Department of Consumer Affairs. For instance, the Medical Practice Act provides for the licensure and regulation of physicians and surgeons by the Medical Board of California and the Osteopathic Act provides for the licensure and regulation of osteopathic physicians and surgeons by the Osteopathic Medical Board of California, among others.

This bill, the Right to Try Individualized Investigational Treatments Act, would permit a manufacturer of an individualized investigational treatment, as defined, to make the product available to eligible patients with life-threatening or severely debilitating illness, as specified. The bill would authorize, but not require, a health benefit plan, as defined, to provide coverage for any individualized investigational treatment made available pursuant to these provisions.

The bill would prohibit a state regulatory board from taking any action against a health care providers license solely on a providers recommendation of or providing access to an individualized investigational treatment.

The bill would prohibit a state agency from altering any recommendation made to the federal Centers for Medicare and Medicaid Services regarding a health care provider's certification to participate in the Medicare or Medicaid program based solely on the recommendation from an individual health care provider that a patient have access to an individualized investigational treatment.