BILL NUMBER:  SB 598
  VETOED	DATE: 10/12/2013




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.