Off the (Moon) Beam

  • by: |
  • 10/14/2013

California Governor Jerry brown has vetoed SB 598, a bill (passed by both houses of the legislature with overwhelming bipartisan support) that would have allowed biosimilars to be substituted by pharmacists if the F.D.A. deemed the biosimilar “interchangeable” with the reference product.  

The California bill would allow substitution of a biosimilar for an innovator product only if FDA declared the biosimilar interchangeable for the specific use; the prescriber had not expressly prohibited use of a biosimilar; the substitution was communicated to patients; the cost to the patient was the same or less than the innovator product; and the pharmacist notified the prescribing physician within five days. The requirement for physician notification would sunset after three years Additionally, the California State Board of Pharmacy would maintain a list of biosimilar products FDA determines to be interchangeable on its website

Patient information? Pharmacist empowerment? Who could be against such a significant public health double play?

According to Governor Brown,

“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.”

(CALPERS is the California Public Employees’ Retirement System, which provides health benefits to more than 1.3 million people.)

“Case doubt on the safety …”

Perhaps the Governor should be made aware of what bioequivalence really means.

Per a report in the New York Times, “Ralph G. Neas, president of the Generic Pharmaceutical Association, celebrated the veto, saying that Mr. Brown had “demonstrated compassion for millions of patients and strong fiscal stewardship for the state of California.”

Nothing like celebrating the victory of cost-centric medicine over patient-centric care.

For shame.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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