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CLSA Wire

Health Advocates Disappointed Following Governor Brown’s Rejection of Patient Access to Biosimilars Bill

SACRAMENTO, Calif. – October 14, 2013 –  Supporters of SB 598 are reacting with disappointment over California Gov. Jerry Brown’s veto Saturday of legislation that would have made the necessary updates to state regulations in anticipation of FDA-approved biosimilar medicines. SB 598 (Hill – San Mateo) received overwhelming bipartisan approval throughout the legislative process, passing 176-13 in five committees and three floor votes in the Assembly and Senate and was supported by hundreds of patient advocate, physician, healthcare, biotech, labor and business groups.

“SB 598 would have established a responsible pathway for increased patient access to additional therapeutic treatment options for life-threatening illnesses as soon as they were available in the U.S. We’re obviously greatly disappointed that the Governor didn’t see this as a priority,” said Eve Bukowski, a stage four cancer survivor and vice president of government affairs for the non-profit California Healthcare Institute, representing more than 275 leading biotechnology, medical device, diagnostics and pharmaceutical companies and public and private academic biomedical research organizations.

Federal health reform created a pathway for the FDA to approve biosimilars. SB 598 would have updated California pharmacy law to allow biosimilars deemed interchangeable by the FDA to be substituted for originally prescribed biologic medicines in the pharmacy setting. SB 598 also included an important provision that physicians be notified as to which biologic therapy a pharmacy dispensed so that the specific medication could be noted and tracked in a patient’s health record.

Stated Dr. John Maa, board member of the San Francisco Medical Society and president of the Northern California Chapter of the American College of Surgeons: “Rejecting SB 598 does not make the need for addressing patient access in the Pharmacy seeting to biosimilars go away.  A legislative remedy will still be required and SB 598’s requirement that there be coordinated and consistent care and communications among doctor-patient-and pharmacist in the dispensing of this new class of life-saving medicines was entirely consistent with the goals of the Affordable Care Act of which patient care and safety are paramount.”

“As healthcare providers, we are the stewards of our patient’s – and ultimately society’s – resources for health,” stated Bryan Liang, MD, PhD, JD, director of the San Diego Center for Patient Safety at the UC San Diego School of Medicine and professor of anesthesiology at UCSD School of Medicine.

“Patient centered care thus requires us to jointly work as a team of professionals, with a focus on using our professional knowledge to promote the best quality, safety, and efficacy of care for our patients. SB 598 would have supported these objectives within the framework of new biologic medicines and it’s unfortunate that the bill wasn’t signed and that California has no policy in place for the pending arrival of biosimilars,” said Dr. Liang.