California 2015-2016 Regular Session Status: To Executive Bipartisan · 2 D · 1 R cosponsors

AB 159 — Investigational drugs, biological products, and devices.

Last action — Consideration of Governor's veto stricken from file.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. ✓
    Passed Assembly
  4. ✓
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 2015-2016 Regular Session. It reached “To Executive” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

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department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the federal Food, Drug, and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 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. 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.

Bill Text

Action History

  1. Consideration of Governor's veto stricken from file.

  2. Vetoed by Governor.

  3. Enrolled and presented to the Governor at 4 p.m.

  4. Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 76. Noes 2. Page 2799.).

  5. Assembly Rule 77 suspended. (Page 2795.)

  6. In Assembly. Concurrence in Senate amendments pending. May be considered on or after September 3 pursuant to Assembly Rule 77.

  7. Read third time. Passed. Ordered to the Assembly. (Ayes 40. Noes 0. Page 2344.).

  8. Read second time. Ordered to third reading.

  9. From committee: Do pass. (Ayes 7. Noes 0.) (August 27).

  10. In committee: Referred to suspense file.

  11. From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on APPR.

  12. From committee: Do pass and re-refer to Com. on APPR. (Ayes 8. Noes 0.) (June 29). Re-referred to Com. on APPR.

  13. From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on B., P. & E.D.

  14. Read second time and amended. Re-referred to Com. on B., P. & E.D.

  15. From committee: Amend, and do pass as amended and re-refer to Com. on B., P. & E.D. (Ayes 8. Noes 0.) (June 10).

  16. From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on HEALTH.

  17. Referred to Coms. on HEALTH and B., P. & E.D.

  18. In Senate. Read first time. To Com. on RLS. for assignment.

  19. Read third time. Passed. Ordered to the Senate. (Ayes 74. Noes 2. Page 1485.)

  20. Read second time. Ordered to third reading.

  21. From committee: Do pass. (Ayes 15. Noes 0.) (May 13).

  22. Re-referred to Com. on APPR.

  23. Read second time and amended.

  24. From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 14. Noes 0.) (April 21).

  25. Re-referred to Com. on B. & P.

  26. Read second time and amended.

  27. From committee: Amend, and do pass as amended and re-refer to Com. on B. & P. (Ayes 17. Noes 0.) (April 7).

  28. Referred to Coms. on HEALTH and B. & P.

  29. From printer. May be heard in committee February 21.

  30. Read first time. To print.

Sponsors

Sponsorship breakdown

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1 sponsors · 10 co-sponsors · 111 not signed on

Sponsors (1)

Co-sponsors (10)

Not signed on (111)

111 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Votes

AB 159 CALDERON Concurrence in Senate Amendments

Passed 76 Yea · 2 Nay · 2 Other
Party YeaNayPresentNot Voting
Unaffiliated 67202
Democratic 4000
Republican 5000
Total 76202
% of votes cast 95%3%0%3%
How each member voted (80)
Member Party Vote
Achadjian — Yea
Alejo — Yea
Baker — Yea
Bloom — Yea
Brough — Yea
Brown — Yea
Kim — Yea
Low — Yea
Maienschein — Yea
Mathis — Yea
Mullin — Yea
Obernolte — Yea
Perea — Yea
Ridley-Thomas — Yea
Steinorth — Yea
Waldron — Yea
Williams — Yea
Eggman — Yea
Cooper — Yea
Frazier — Yea
Chávez — Yea
Gatto — Yea
Harper — Yea
Salas — Yea
Jones-Sawyer — Yea
Olsen — Yea
Wagner — Yea
Burke — Yea
Bonilla — Yea
Gomez — Yea
Gordon — Not Voting
Hadley — Yea
Gray — Yea
Holden — Yea
Lopez — Yea
Levine — Nay
Linder — Yea
Mayes — Yea
McCarty — Yea
Medina — Yea
Melendez — Yea
Campos — Yea
Atkins — Yea
Nazarian — Not Voting
O'Donnell — Yea
Bigelow — Yea
Chang — Yea
Chau — Yea
Chiu — Yea
Chu — Yea
Cooley — Yea
Dababneh — Yea
Daly — Yea
Dodd — Yea
Quirk — Nay
Rendon — Yea
Rodriguez — Yea
Santiago — Yea
Thurmond — Yea
Ting — Yea
Weber — Yea
Wilk — Yea
Wood — Yea
Beth Gaines — Yea
Cristina Garcia — Yea
Eduardo Garcia — Yea
Jim Patterson — Yea
Lorena Gonzalez — Yea
Mark Stone — Yea
Roger Hernández — Yea
Travis Allen — Yea
Bonta, Mia Democratic Yea
Calderon, Lisa Democratic Yea
Gipson, Mike A. Democratic Yea
Irwin, Jacqui Democratic Yea
Dahle, Megan Republican Yea
Gallagher, James Republican Yea
Grove, Shannon Republican Yea
Jones, Brian W. Republican Yea
Lackey, Tom Republican Yea

Official roll call →

3rd Reading AB159 Calderon By Stone

Passed 40 Yea · 0 Nay
Party YeaNayPresentNot Voting
Unaffiliated 37000
Democratic 3000
Total 40000
% of votes cast 100%0%0%0%
How each member voted (40)
Member Party Vote
Anderson — Yea
Block — Yea
Hertzberg — Yea
Hill — Yea
Leyva — Yea
Moorlach — Yea
Pan — Yea
Vidak — Yea
Wieckowski — Yea
Wolk — Yea
Galgiani — Yea
Glazer — Yea
Lara — Yea
Leno — Yea
Allen — Yea
Mitchell — Yea
De León — Yea
Runner — Yea
Cannella — Yea
Hall — Yea
Hernandez — Yea
Hueso — Yea
Huff — Yea
Bates — Yea
Beall — Yea
Liu — Yea
Mendoza — Yea
Monning — Yea
Morrell — Yea
Nielsen — Yea
Pavley — Yea
Roth — Yea
Fuller — Yea
Hancock — Yea
Beth Gaines — Yea
Bill Berryhill — Yea
Mark Stone — Yea
Jackson, Corey A. Democratic Yea
McGuire, Mike Democratic Yea
Nguyen, Stephanie Democratic Yea

Official roll call →

Do pass

Passed 7 Yea · 0 Nay
Party YeaNayPresentNot Voting
Unaffiliated 7000
Total 7000
% of votes cast 100%0%0%0%
How each member voted (7)
Member Party Vote
Bates — Yea
Hill — Yea
Leyva — Yea
Mendoza — Yea
Nielsen — Yea
Lara — Yea
Beall — Yea

Official roll call →

Placed on suspense file

Passed 7 Yea · 0 Nay
Party YeaNayPresentNot Voting
Unaffiliated 7000
Total 7000
% of votes cast 100%0%0%0%
How each member voted (7)
Member Party Vote
Bates — Yea
Beall — Yea
Hill — Yea
Lara — Yea
Leyva — Yea
Mendoza — Yea
Nielsen — Yea

Official roll call →

AB 159 CALDERON Assembly Third Reading

Passed 74 Yea · 2 Nay · 4 Other
Party YeaNayPresentNot Voting
Unaffiliated 64204
Democratic 4000
Republican 6000
Total 74204
% of votes cast 93%3%0%5%
How each member voted (80)
Member Party Vote
Achadjian — Yea
Alejo — Yea
Baker — Yea
Bloom — Yea
Brough — Yea
Brown — Yea
Linder — Yea
Maienschein — Yea
Mathis — Not Voting
Obernolte — Yea
Santiago — Yea
Wagner — Yea
Waldron — Yea
Williams — Yea
Eggman — Yea
Daly — Yea
Frazier — Yea
Gatto — Yea
Campos — Yea
Harper — Yea
Salas — Yea
Bonilla — Yea
Jones-Sawyer — Yea
Bigelow — Yea
Chávez — Yea
Cooper — Yea
Low — Yea
Mayes — Yea
Medina — Yea
Olsen — Yea
Perea — Yea
Rendon — Yea
Kim — Not Voting
Levine — Nay
Melendez — Not Voting
Quirk — Nay
Gray — Yea
Mullin — Yea
Nazarian — Yea
Dababneh — Yea
Dodd — Yea
O'Donnell — Yea
Lopez — Yea
Gomez — Yea
Holden — Yea
McCarty — Yea
Burke — Yea
Atkins — Yea
Ridley-Thomas — Yea
Rodriguez — Yea
Chang — Yea
Chau — Yea
Chiu — Yea
Chu — Yea
Cooley — Yea
Steinorth — Yea
Thurmond — Yea
Ting — Yea
Weber — Yea
Wilk — Yea
Wood — Yea
Gonzalez — Yea
Gordon — Not Voting
Hadley — Yea
Beth Gaines — Yea
Cristina Garcia — Yea
Eduardo Garcia — Yea
Mark Stone — Yea
Roger Hernández — Yea
Travis Allen — Yea
Bonta, Mia Democratic Yea
Calderon, Lisa Democratic Yea
Gipson, Mike A. Democratic Yea
Irwin, Jacqui Democratic Yea
Dahle, Megan Republican Yea
Gallagher, James Republican Yea
Grove, Shannon Republican Yea
Jones, Brian W. Republican Yea
Lackey, Tom Republican Yea
Patterson, Joe Republican Yea

Official roll call →

Do pass.

Passed 15 Yea · 0 Nay · 2 Other
Party YeaNayPresentNot Voting
Unaffiliated 12001
Democratic 2000
Republican 1001
Total 15002
% of votes cast 88%0%0%12%
How each member voted (17)
Member Party Vote
Bloom — Yea
Quirk — Not Voting
Weber — Yea
Eggman — Yea
Gomez — Yea
Holden — Yea
Chang — Yea
Bigelow — Yea
Daly — Yea
Rendon — Yea
Wagner — Yea
Wood — Yea
Eduardo Garcia — Yea
Bonta, Mia Democratic Yea
Calderon, Lisa Democratic Yea
Gallagher, James Republican Not Voting
Jones, Brian W. Republican Yea

Official roll call →

Do pass as amended and be re-referred to the Committee on [Appropriations]

Passed 14 Yea · 0 Nay
Party YeaNayPresentNot Voting
Unaffiliated 13000
Republican 1000
Total 14000
% of votes cast 100%0%0%0%
How each member voted (14)
Member Party Vote
Baker — Yea
Bloom — Yea
Eggman — Yea
Campos — Yea
Gatto — Yea
Dodd — Yea
Bonilla — Yea
Holden — Yea
Mullin — Yea
Ting — Yea
Wilk — Yea
Wood — Yea
Chang — Yea
Jones, Brian W. Republican Yea

Official roll call →

Do pass as amended and be re-referred to the Committee on [Business and Professions]

Passed 17 Yea · 0 Nay · 2 Other
Party YeaNayPresentNot Voting
Democratic 1000
Republican 2000
Unaffiliated 14002
Total 17002
% of votes cast 89%0%0%11%
How each member voted (19)
Member Party Vote
Maienschein — Yea
Santiago — Yea
Burke — Yea
Bonilla — Not Voting
Gomez — Yea
Chiu — Yea
Chávez — Not Voting
Nazarian — Yea
Ridley-Thomas — Yea
Rodriguez — Yea
Steinorth — Yea
Thurmond — Yea
Waldron — Yea
Wood — Yea
Gonzalez — Yea
Roger Hernández — Yea
Bonta, Mia Democratic Yea
Lackey, Tom Republican Yea
Patterson, Joe Republican Yea

Official roll call →

Subjects

healthcare health-insurance
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Frequently asked questions

What does AB 159 do?
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 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. 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.
Who sponsors AB 159?
AB 159 is sponsored by Anderson, Brown, Daly, Lackey, Tom (Republican), Obernolte, Olsen, Waldron, Calderon, Lisa (Democratic), Garcia, Robert (Democratic), Travis Allen, and Mark Stone.
What is the current status of AB 159?
This bill died with 2015-2016 Regular Session. It reached “To Executive” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track AB 159?
Track AB 159 free on One Click Politics — get push/email alerts when it moves.

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