BayBio and BIOCOM Commend Passage of AB 1277 to Reduce Redundant Facilities Inspections
Oct 1, 2012
SAN FRANCISCO and SAN DIEGO, Calif – October 1, 2012 – BayBio and BIOCOM, the trade associations for the Northern and Southern California life science clusters respectively, today thanked Governor Jerry Brown and Assemblyman Jerry Hill (D-San Mateo) upon the signing of his AB 1277, legislation which addresses facility inspections by state regulators that are largely duplicative of those already done by the US Food and Drug Administration (FDA). AB 1277 will eliminate many of those state facility inspections, which often look for the same issues as those covered in federal inspections.
“I was very pleased to carry this bill in response to concerns the industry raised on duplicative facility inspections,” said Assemblyman Jerry Hill (D-San Mateo). “The life science industry is a critical part of both my district’s and the state’s economies, and we took great care in crafting language which will significantly reduce duplicative facility inspections by the state while maintaining public safety. ”
AB 1277 will require that the Food and Drug Branch (FDB) of the California Department of Public Health accept the certification and findings of the FDA in most cases instead of requiring a separate state facility inspection, as is current practice. “These state facility inspections provide little in the way of protecting and preserving public health, but they cost companies millions of dollars in lost productivity to accommodate the inspections,” stated Joe Panetta, President and CEO of BIOCOM. “Governor Brown has challenged business to bring him ways government can be more efficient, and we are thankful Assemblyman Hill and Governor Brown took action when potential solutions were presented to them.” The legislation preserves the mission of the FDB to inspect a business if there is reason to believe public health may be at risk, or if the FDA has requested its assistance.
Combined, BayBio and BIOCOM represent almost a thousand of the state’s life science and associated support companies. The two associations and their members, along with the California Healthcare Institute, worked with Assemblyman Hill for almost two years to craft the correct legislative vehicle.
“Life science companies throughout the state have a champion in Assemblyman Jerry Hill,” concluded Gail Maderis, President and CEO of BayBio. “When we identified a specific problem to him, he worked with us to craft a solution that was both acceptable to the regulators and allowed companies to continue to create much-needed jobs in the state. We thank him for his hard work on AB 1277 and thank the Governor for his signature on this legislation.”
BayBio is Northern California’s life science association, supporting the regional bioscience community through advocacy, enterprise support, and the enhancement of research collaboration. Its members include organizations engaged in, or supportive of, research, development and commercialization of life science technologies. Online at www.baybio.org. Follow BayBio on Twitter at @baybio.
BIOCOM is one of the largest regional life science associations in the world, representing more than 560 member companies in Southern California. The association focuses on initiatives that position the region’s life science industry competitively on the world stage, and on the development and delivery of innovative products that improve health and quality of life. For more information on BIOCOM or the Southern California biotechnology and medical device community, please visit the organization’s Web site at http://www.biocom.org or call (858) 455-0300.