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SB-598 Biosimilars.(2013-2014)

Senate:
Int
1st
Cmt
2nd
Cmt
2nd
3rd
Pass
Pass
Veto
Assembly:
1st
Cmt
2nd
Cmt
2nd
3rd
Pass
Bill Status
SB-598
Hill (S)
-
Gorell (A) , Mullin (A)
Biosimilars.
03/25/13
An act to add Section 4073.5 to the Business and Professions Code, relating to pharmacy.
Senate
09/19/13
08/06/13

Type of Measure
Inactive Bill - Vetoed
Majority Vote Required
Non-Appropriation
Fiscal Committee
State-Mandated Local Program
Non-Urgency
Non-Tax levy
Last 5 History Actions
Date Action
02/27/14 Consideration of Governor's veto stricken from file.
10/12/13 In Senate. Consideration of Governor's veto pending.
10/12/13 Vetoed by the Governor.
09/23/13 Enrolled and presented to the Governor at 2 p.m.
09/04/13 Assembly amendments concurred in. (Ayes 30. Noes 2. Page 2132.) Ordered to engrossing and enrolling.
Governor's Veto Message
To the Members of the California State Senate:

Senate Bill 598 would effect two changes to our state's pharmacy law. First, it would allow interchangeable "biosimilar" drugs to be substituted for biologic drugs, once these interchangeable drugs are approved by the federal Food and Drug Administration (FDA). This is a policy I strongly support.

Second, it requires pharmacists to send notifications back to prescribers about which drug was dispensed. This requirement, which on its face looks reasonable, is for some reason highly controversial. Doctors with whom I have spoken would welcome this information. CalPERS and other large purchasers warn that the requirement itself would cast doubt on the safety and desirability of more cost-effective alternatives to biologics.

The FDA, which has jurisdiction for approving all drugs, has not yet determined what standards will be required for biosimilars to meet the higher threshold for "interchangeability." Given this fact, to require physician notification at this point strikes me as premature.

For these reasons, I am returning SB 598 without my signature.

Sincerely,



Edmund G. Brown Jr.