California 2013-2014 Regular Session Status: To Executive

SB 598 — Biosimilars.

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

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

This bill died with 2013-2014 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This bill is no longer active — its legislative session has ended, so there is no live prognosis.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

The Pharmacy Law governs the practice of pharmacy in this state, including the permissible duties of licensed pharmacists. Among other permitted acts, a pharmacist filling a prescription order for a drug product prescribed by its trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name as determined, as specified, of those drug products having the same active chemical ingredients. A person who knowingly violates the Pharmacy Law is guilty of a misdemeanor, as specified. This bill would authorize a pharmacist, in his or her discretion, except as specified, to select a biosimilar, as defined, when filling a prescription order for a prescribed biological product only if the product has been approved by the federal Food and Drug Administration, as specified, and the prescriber does not personally indicate "Do not substitute," as specified. The bill would also require, for prescriptions filled prior to January 1, 2017, the pharmacy to, within 5 business days of the selection of a biological product or an interchangeable biosimilar, notify the prescriber or enter in a patient record whether the prescription dispensed was a biological product or an interchangeable biosimilar, except as specified. The bill would prohibit a pharmacist from selecting a biosimilar that meets the requirements of these provisions unless the cost to the patient of the biosimilar selected is the same or less than the cost of the prescribed biological product. The bill would also require that the substitution of a biosimilar be communicated to the patient. Because a knowing violation of these requirements would be a misdemeanor, the bill would create new crimes, thereby imposing a state-mandated local program. The bill would also require the California State Board of Pharmacy to maintain on its public Internet Web site a link to the current list, if available, of biosimilar products determined by the federal Food and Drug Administration to be interchangeable, as specified. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.

Bill Text

Action History

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

  2. In Senate. Consideration of Governor's veto pending.

  3. Vetoed by the Governor.

  4. Enrolled and presented to the Governor at 2 p.m.

  5. Assembly amendments concurred in. (Ayes 30. Noes 2. Page 2132.) Ordered to engrossing and enrolling.

  6. In Senate. Concurrence in Assembly amendments pending.

  7. Read third time. Passed. (Ayes 60. Noes 4. Page 2722.) Ordered to the Senate.

  8. Read second time. Ordered to third reading.

  9. From committee: Do pass. (Ayes 15. Noes 0.) (August 21).

  10. Hearing postponed by committee.

  11. Read second time and amended. Re-referred to Com. on APPR.

  12. From committee: Do pass as amended and re-refer to Com. on APPR. (Ayes 14. Noes 2.) (July 2).

  13. From committee: Do pass and re-refer to Com. on HEALTH. (Ayes 12. Noes 0.) (June 25). Re-referred to Com. on HEALTH.

  14. From committee with author's amendments. Read second time and amended. Re-referred to Com. on B.,P. & C.P.

  15. Referred to Coms. on B.,P. & C.P. and HEALTH.

  16. In Assembly. Read first time. Held at Desk.

  17. Read third time. Passed. (Ayes 29. Noes 4. Page 1044.) Ordered to the Assembly.

  18. Read second time. Ordered to third reading.

  19. From committee: Be placed on second reading file pursuant to Senate Rule 28.8.

  20. Set for hearing May 20.

  21. Hearing postponed by committee.

  22. Set for hearing May 13.

  23. From committee: Do pass and re-refer to Com. on APPR. (Ayes 6. Noes 1. Page 791.) (May 1). Re-referred to Com. on APPR.

  24. Set for hearing May 1.

  25. Read second time and amended. Re-referred to Com. on HEALTH.

  26. From committee: Do pass as amended and re-refer to Com. on HEALTH. (Ayes 10. Noes 0. Page 464.) (April 8).

  27. Set for hearing April 8.

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

  29. Read first time.

  30. From printer. May be acted upon on or after March 25.

  31. Introduced. To Com. on RLS. for assignment. To print.

Sponsors

  • Gorell · Cosponsor
  • Hill · Primary
  • Mullin · Cosponsor

Sponsorship breakdown

Export CSV (upgrade) →

1 sponsors · 2 co-sponsors · 119 not signed on · 1 voted No

Sponsors (1)

  • Hill

Co-sponsors (2)

  • Gorell
  • Mullin

Not signed on (119)

119 members have not signed on to this bill.

Show all 119 →

"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

Unfinished Business SB598 Hill Concurrence

Passed 30 Yea · 2 Nay · 7 Other
Party YeaNayPresentNot Voting
Unaffiliated 29106
Democratic 1101
Total 30207
% of votes cast 77%5%0%18%
How each member voted (39)
Member Party Vote
Anderson — Yea
Beall — Yea
Block — Yea
Knight — Yea
Nielsen — Yea
Steinberg — Yea
Vidak — Yea
Wolk — Yea
Emmerson — Yea
Correa — Yea
DeSaulnier — Not Voting
Wright — Nay
Wyland — Yea
De León — Yea
Cannella — Yea
Evans — Not Voting
Fuller — Yea
Galgiani — Yea
Hancock — Yea
Hernandez — Yea
Hill — Yea
Corbett — Yea
Hueso — Not Voting
Huff — Yea
Lara — Yea
Leno — Yea
Lieu — Yea
Liu — Not Voting
Monning — Not Voting
Pavley — Yea
Roth — Yea
Torres — Not Voting
Walters — Yea
Yee — Yea
Beth Gaines — Yea
Bill Berryhill — Yea
Calderon, Lisa Democratic Nay
Jackson, Corey A. Democratic Yea
Padilla, Stephen C. Democratic Not Voting

Official roll call →

SB 598 Hill Senate Third Reading By PAN

Passed 60 Yea · 4 Nay · 14 Other
Party YeaNayPresentNot Voting
Unaffiliated 544013
Democratic 3001
Republican 3000
Total 604014
% of votes cast 77%5%0%18%
How each member voted (78)
Member Party Vote
Achadjian — Yea
Alejo — Yea
Bloom — Nay
Bradford — Yea
Brown — Yea
Buchanan — Yea
Holden — Yea
Linder — Yea
Mansoor — Yea
Olsen — Yea
Perea — Yea
Rendon — Not Voting
Wagner — Yea
Waldron — Yea
Wilk — Yea
Gorell — Yea
Logue — Yea
Allen — Yea
Gatto — Yea
Atkins — Yea
Yamada — Nay
Gomez — Yea
Mitchell — Yea
Campos — Yea
Bonilla — Yea
Gordon — Yea
Harkey — Yea
Jones-Sawyer — Yea
Bocanegra — Yea
John A. Pérez — Yea
Levine — Yea
Salas — Yea
Maienschein — Yea
Chau — Yea
Medina — Yea
Melendez — Yea
Lowenthal — Nay
Morrell — Yea
Mullin — Yea
Nazarian — Yea
Chesbro — Not Voting
Fong — Not Voting
Nestande — Yea
Garcia — Not Voting
Gray — Not Voting
Ammiano — Not Voting
Bigelow — Yea
Chávez — Yea
Conway — Yea
Cooley — Yea
Daly — Not Voting
Dickinson — Not Voting
Donnelly — Not Voting
Eggman — Yea
Pan — Yea
Quirk — Yea
Skinner — Not Voting
Ting — Yea
Weber — Yea
Wieckowski — Not Voting
Williams — Yea
Fox — Not Voting
Frazier — Nay
Hagman — Yea
Hall — Yea
Beth Gaines — Yea
Jim Patterson — Yea
Lorena Gonzalez — Yea
Mark Stone — Yea
Roger Hernández — Not Voting
V. Manuel Pérez — Yea
Bonta, Mia Democratic Yea
Calderon, Lisa Democratic Yea
Muratsuchi, Al Democratic Not Voting
Quirk-Silva, Sharon Democratic Yea
Dahle, Megan Republican Yea
Grove, Shannon Republican Yea
Jones, Brian W. Republican Yea

Official roll call →

Do pass.

Passed 15 Yea · 0 Nay · 2 Other
Party YeaNayPresentNot Voting
Unaffiliated 14002
Democratic 1000
Total 15002
% of votes cast 88%0%0%12%
How each member voted (17)
Member Party Vote
Bigelow — Yea
Bradford — Yea
Holden — Yea
Linder — Yea
Wagner — Yea
Campos — Yea
Quirk — Yea
Bocanegra — Yea
Weber — Yea
Gatto — Yea
Gomez — Yea
Hall — Not Voting
Harkey — Not Voting
Eggman — Yea
Pan — Yea
Donnelly — Yea
Calderon, Lisa Democratic Yea

Official roll call →

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

Passed 14 Yea · 2 Nay · 3 Other
Party YeaNayPresentNot Voting
Unaffiliated 13203
Democratic 1000
Total 14203
% of votes cast 74%11%0%16%
How each member voted (19)
Member Party Vote
Ammiano — Not Voting
Logue — Yea
Maienschein — Yea
Mansoor — Yea
Chesbro — Nay
Bonilla — Yea
Mitchell — Yea
Atkins — Yea
Lowenthal — Nay
Nazarian — Yea
Nestande — Yea
Pan — Yea
Wagner — Yea
Wieckowski — Not Voting
Wilk — Yea
Gomez — Yea
Roger Hernández — Not Voting
V. Manuel Pérez — Yea
Bonta, Mia Democratic Yea

Official roll call →

Do pass and be re-referred to the Committee on Health.

Passed 12 Yea · 0 Nay · 1 Other
Party YeaNayPresentNot Voting
Unaffiliated 11001
Republican 1000
Total 12001
% of votes cast 92%0%0%8%
How each member voted (13)
Member Party Vote
Holden — Yea
Ting — Yea
Wilk — Yea
Gordon — Yea
Bocanegra — Yea
Bonilla — Yea
Hagman — Yea
Campos — Yea
Maienschein — Yea
Mullin — Yea
Skinner — Yea
Dickinson — Not Voting
Jones, Brian W. Republican Yea

Official roll call →

3rd Reading

Passed 29 Yea · 4 Nay · 6 Other
Party YeaNayPresentNot Voting
Unaffiliated 27306
Democratic 2100
Total 29406
% of votes cast 74%10%0%15%
How each member voted (39)
Member Party Vote
Anderson — Yea
Lara — Not Voting
Monning — Not Voting
Price — Yea
Torres — Not Voting
Walters — Yea
Wyland — Yea
Emmerson — Yea
Correa — Yea
Beall — Yea
Galgiani — Yea
Hernandez — Yea
Huff — Yea
Leno — Yea
Wright — Nay
De León — Yea
Yee — Yea
Cannella — Yea
Block — Yea
Corbett — Yea
Evans — Not Voting
Hill — Yea
Hueso — Yea
Knight — Yea
Lieu — Yea
Liu — Not Voting
Nielsen — Nay
Pavley — Yea
Roth — Yea
Steinberg — Yea
Wolk — Yea
DeSaulnier — Nay
Fuller — Yea
Hancock — Yea
Beth Gaines — Yea
Bill Berryhill — Not Voting
Calderon, Lisa Democratic Nay
Jackson, Corey A. Democratic Yea
Padilla, Stephen C. Democratic Yea

Official roll call →

Do pass, but re-refer to the Committee on Appropriations.

Passed 6 Yea · 1 Nay · 2 Other
Party YeaNayPresentNot Voting
Unaffiliated 6102
Total 6102
% of votes cast 67%11%0%22%
How each member voted (9)
Member Party Vote
Anderson — Yea
Beall — Yea
Hernandez — Yea
Nielsen — Nay
De León — Yea
Monning — Not Voting
Pavley — Yea
Wolk — Yea
DeSaulnier — Not Voting

Official roll call →

Subjects

healthcare health-insurance
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Frequently asked questions

What does SB 598 do?
The Pharmacy Law governs the practice of pharmacy in this state, including the permissible duties of licensed pharmacists. Among other permitted acts, a pharmacist filling a prescription order for a drug product prescribed by its trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name as determined, as specified, of those drug products having the same active chemical ingredients. A person who knowingly violates the Pharmacy Law is guilty of a misdemeanor, as specified. This bill would authorize a pharmacist, in his or her discretion, except as specified, to select a biosimilar, as defined, when filling a prescription order for a prescribed biological product only if the product has been approved by the federal Food and Drug Administration, as specified, and the prescriber does not personally indicate "Do not substitute," as specified. The bill would also require, for prescriptions filled prior to January 1, 2017, the pharmacy to, within 5 business days of the selection of a biological product or an interchangeable biosimilar, notify the prescriber or enter in a patient record whether the prescription dispensed was a biological product or an interchangeable biosimilar, except as specified. The bill would prohibit a pharmacist from selecting a biosimilar that meets the requirements of these provisions unless the cost to the patient of the biosimilar selected is the same or less than the cost of the prescribed biological product. The bill would also require that the substitution of a biosimilar be communicated to the patient. Because a knowing violation of these requirements would be a misdemeanor, the bill would create new crimes, thereby imposing a state-mandated local program. The bill would also require the California State Board of Pharmacy to maintain on its public Internet Web site a link to the current list, if available, of biosimilar products determined by the federal Food and Drug Administration to be interchangeable, as specified. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.
Who sponsors SB 598?
SB 598 is sponsored by Gorell, Hill, and Mullin.
What is the current status of SB 598?
This bill died with 2013-2014 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 SB 598?
Track SB 598 free on One Click Politics — get push/email alerts when it moves.

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