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 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department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the federal Food, Drug, and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. The Medical Practice Act provides for the licensure and regulation of physicians and surgeons by the Medical Board of California and requires the board to take action against a licensee who is charged with unprofessional conduct. The Osteopathic Act provides for the licensure and regulation of osteopathic physicians and surgeons by the Osteopathic Medical Board of California and requires the board to enforce the Medical Practice Act with respect to its licensees. This bill would permit a manufacturer of an investigational drug, biological product, or device to make the product available to eligible patients with an immediately life-threatening disease or condition, as specified. The bill would authorize, but not require, a health benefit plan, as defined, to provide coverage for any investigational drug, biological product, or device made available pursuant to these provisions. The bill would prohibit the Medical Board of California and the Osteopathic Medical Board of California from taking any disciplinary action against the license of a physician based on the physician's recommendation to an eligible patient regarding, or prescription for, or treatment with, an investigational drug, biological product, or device if the recommendation or prescription is consistent with protocol approved by the physician's institutional review board or an accredited institutional review board, and would require the institutional review board to biannually report specified information to the State Department of Public Health, among others. 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 investigational drug, biological product, or device.
Approved by the Governor.
Chaptered by Secretary of State - Chapter 684, Statutes of 2016.
Enrolled and presented to the Governor at 4 p.m.
Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 77. Noes 2. Page 6157.).
In Assembly. Concurrence in Senate amendments pending. May be considered on or after August 21 pursuant to Assembly Rule 77.
Read third time. Passed. Ordered to the Assembly. (Ayes 38. Noes 0. Page 5117.).
Read second time and amended. Ordered to third reading.
From committee: Amend, and do pass as amended. (Ayes 7. Noes 0.) (August 11).
From committee: Do pass and re-refer to Com. on B., P. & E.D. (Ayes 9. Noes 0.) (June 22). Re-referred to Com. on B., P. & E.D.
In Senate. Read first time. To Com. on RLS. for assignment.
Read third time. Passed. Ordered to the Senate. (Ayes 77. Noes 2. Page 5020.)
Read second time. Ordered to third reading.
From committee: Do pass. (Ayes 20. Noes 0.) (May 27).
From committee: Do pass and re-refer to Com. on APPR. (Ayes 14. Noes 0.) (March 29). Re-referred to Com. on APPR.
From committee: Do pass and re-refer to Com. on B. & P. (Ayes 18. Noes 0.) (March 15). Re-referred to Com. on B. & P.
From committee chair, with author's amendments: Amend, and re-refer to Com. on HEALTH. Read second time and amended.
From printer. May be heard in committee February 18.
Read first time. To print.
|Bill Text Versions||Format|
|01/15/16 - Introduced|
|03/07/16 - Amended Assembly|
|08/15/16 - Amended Senate|
|08/25/16 - Enrolled|
|09/27/16 - Chaptered|
|No related documents.|
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