Stone
Author
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department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the Federal Food, Drug, and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, among other things, 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 provide that the act does not require a health benefit plan, as defined, or governmental agency to provide coverage for the cost of any investigational drug, biological product, or device made available pursuant to these provisions, but would authorize a health benefit plan to provide coverage for an investigational drug, biological product, or device. The bill would also 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 solely 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.
August 27 hearing: Held in committee and under submission.
August 19 set for first hearing. Placed on APPR. suspense file.
Read second time and amended. Re-referred to Com. on APPR.
From committee: Do pass as amended and re-refer to Com. on APPR. (Ayes 14. Noes 0.) (July 7).
From committee: Do pass and re-refer to Com. on B. & P. (Ayes 17. Noes 0.) (June 30). Re-referred to Com. on B. & P.
In Assembly. Read first time. Held at Desk.
Read third time. Passed. (Ayes 39. Noes 0. Page 1243.) Ordered to the Assembly.
From committee: Do pass. (Ayes 7. Noes 0. Page 1148.) (May 28).
Read second time. Ordered to third reading.
Set for hearing May 28.
May 18 hearing: Placed on APPR. suspense file.
Set for hearing May 18.
Read second time and amended. Re-referred to Com. on APPR.
From committee: Do pass as amended and re-refer to Com. on APPR. (Ayes 9. Noes 0.) (April 27).
Set for hearing April 27.
From committee: Do pass and re-refer to Com. on B., P. & E.D. (Ayes 7. Noes 0. Page 757.) (April 22). Re-referred to Com. on B., P. & E.D.
From committee with author's amendments. Read second time and amended. Re-referred to Com. on HEALTH.
Set for hearing April 22.
April 15 set for first hearing canceled at the request of author.
Set for hearing April 15.
Referred to Coms. on HEALTH and B., P. & E.D.
From printer. May be acted upon on or after March 1.
Introduced. Read first time. To Com. on RLS. for assignment. To print.
| Bill Text Versions | Format |
|---|---|
| SB149 | HTML |
| 01/29/15 - Introduced | |
| 04/14/15 - Amended Senate | |
| 05/05/15 - Amended Senate | |
| 07/13/15 - Amended Assembly |
| Document | Format |
|---|---|
| No related documents. |
Data on Open States is updated periodically throughout the day from the official website of the California State Legislature.
If you notice any inconsistencies with these official sources, feel free to file an issue.