Supporters of SB 598 are reacting with disappointment over California Gov. Jerry Brown’s veto of legislation that would have made the necessary updates to state regulations in anticipation of FDA approval of biosimilar medicines. SB 598 received overwhelming bipartisan approval throughout the legislative process, passing 176-13 in five committees and three floor votes in the Assembly and Senate.
“SB 598 would have established a responsible pathway for increased patient access to biologic medicines for life-threatening illnesses as soon as they were available in the U.S.,” said Eve Bukowski, a stage four cancer survivor and vice president of government affairs for the nonprofit California Healthcare Institute, representing more than 275 biotechnology, medical device, diagnostics and pharmaceutical companies and public and private academic biomedical research organizations.
“The Governor recognized that physicians want notification on the use of biologics but he failed to recognize that the FDA cannot affect whether physicians in California will be notified of the biologic medicines their patients receive at a pharmacy. Only state regulations can do that. The hundreds of patient advocate, physician, healthcare, biotech, labor and business groups who fought for the bill’s passage are understandably concerned about the Governor’s decision, which leaves California’s healthcare delivery system unprepared to administer these life-saving medicines,” said Bukowski.
Dr. John Maa, board member of the San Francisco Medical Society and president of the Northern California Chapter of the American College of Surgeons, said, “Rejecting SB 598 does not make the need for addressing patient access to biosimilars in the pharmacy setting go away. A legislative remedy will still be required and SB 598’s provision 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,” said Bryan Liang, M.D., Ph.D., 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 work as a team of professionals, with a focus on using our 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.”
Federal healthcare reform created a pathway for the FDA to approve biosimilars, which are highly similar copies of biologic medicines, but not exactly the same. 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 the prescribing physician is notified about which biologic therapy was dispensed at a pharmacy so that the specific medication can be noted and tracked in a patient’s health record.