La Jolla, Calif. (PRWEB) September 28, 2012
CHI-California Healthcare Institute today issued the following statement from David L. Gollaher, Ph.D., CHI’s president and CEO, regarding the passage of AB 1277 (Hill), which amends the Sherman Food, Drug and Cosmetic Law to more effectively regulate the state’s biomedical manufacturers:
“Recognizing that the biomedical industry is an economic engine for the state that improves the lives of people worldwide, the administration and state legislators approved CHI-co-sponsored AB 1277 today, eliminating duplicative inspections of drug and device manufacturers. CHI is pleased that state leadership understands this onerous regulation places a financial burden on these companies, affecting job growth and public health.
“U.S. drug and device companies are subject to oversight, approval, and inspection by the federal Food and Drug Administration (FDA), which performs stringent oversight of drug and device manufacturers. Beyond the rigors of product approvals, inspections take place throughout the development process and on a regular basis after a product is approved or cleared for patient use. This oversight is the same for all 50 states in the U.S.
“California is the only state that has duplicate regulations requiring state-level permitting and inspection of drug and medical device facilities through its California Department of Public Health’s Food and Drug Branch licenses. This duplicative regulation creates additional hurdles to drug and device business’ ability to manufacture and create jobs in California by requiring companies to be licensed by the state prior to initiating manufacturing or distribution of specified commodities, even though their products, including their manufacturing processes, have already been approved by the FDA. The inspections cost individual companies hundreds of thousands of dollars for similar and overlapping inspections that provide no benefit to the public.
“It is imperative that government does not stifle this unique California industry, which added 12,000 jobs between 2005 and 2009, and today employs roughly 267,000 workers. CHI thanks Assemblymember Jerry Hill for carrying AB 1277 and applauds Gov. Jerry Brown in signing legislation that will address these hurdles to biomedical manufacturing in California.”
CHI represents more than 275 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. CHI’s mission is to advance responsible public policies that foster medical innovation and promote scientific discovery. CHI’s website is http://www.chi.org. Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.