Administration Weighs in on Electronic Pedigree Legislation
After two years on the sidelines on discussions on electronic pedigree, the Schwarzenegger Administration (State and Consumer Services Agency) injected itself into the debate on Wednesday, June 18, proposing language to SB 1307, authored by Senator Mark Ridley-Thomas (D-Los Angeles).  The provision would only require the use of an electronic pedigree if the dangerous drug were moved outside the “accredited distribution chain” – defined as a chain of custody during distribution of a prescription drug that goes from a manufacturer to a wholesaler to a pharmacy to a patient.  Because representatives from the Administration have yet to meet with the author’s office, the amendments will not be included as part of a legislative hearing on Tuesday, June 24, in the Assembly Business Professions Committee.  Earlier this week, amendments were released on timelines for a phased-in implementation, grandfathering and inference.  CHI continues to engage with members, policy makers and other stakeholders to ensure the needs of our membership are addressed.

Burdensome Syringe Disposal Bill Fails to Provide Comprehensive Solution
The Senate Health Committee will hold a legislative hearing Wednesday, June 25, to discuss medical waste disposal legislation that would impose an unnecessary burden on manufacturers in California.  AB 501, authored by Assemblyman Sandre Swanson (D-Oakland), would require manufacturers of home-use prefilled syringes, pens or other injection devices to provide sharps containers (prepaid mail back or other transport), or coupons that can be exchanged for, or a toll-free number or website that can direct patients to, a qualified sharps container.  The bill would also require certain labeling and notice requirements that may be subject to U.S. Food and Drug Administration regulation, increasing costs for CHI members.  There is already a law that goes into effect on Sept. 1, 2008, which appropriately requires consumers to comply with the disposal of sharps waste.  CHI believes that it is unreasonable to suppose that individuals who fail to comply with that law will alter their behavior because another law is passed.  CHI is actively opposing this bill. The author neglected to follow up on an agreement, which allowed the measure to pass the Assembly Floor, to discuss amendments that would alleviate industry concerns.

Chemical Exposure Bill Moves Out of Committee Despite CHI’s Concerns
On Monday, June 16, the Senate Environmental Quality Committee approved AB 515, authored by Assemblywoman Sally Lieber (D-Mountain View), legislation that would require California’s Occupational Safety and Health Standards Board to duplicate its rulemaking for hundreds of chemicals that already have permissible exposure limits (PEL) standards.  California already has the most stringent workplace chemical exposure limits in the nation.  CHI is opposing this bill as AB 515 would add high costs to the state to implement and would make it more expensive for industry to research, develop and manufacture medical technologies.  The measure now moves to the Senate Appropriations Committee where CHI has a good opportunity to stop the bill, focusing on the potential costs of implementation.

Deadline Extended for Public Comment on Chemical Proposal
On June 17, the Office of Environmental Health Hazard Assessment (OEHHA) held a public workshop to discuss its Labor Code Mechanism Regulator Concept, a major expansion of Proposition 65 chemical listings.  Proposition 65 provides that the governor must publish a list of chemicals “known to the state” to cause carcinogenicity or reproductive toxicity.  Industry groups are very concerned about a major list expansion that provides no opportunity for public comment or scientific assessment.  At the meeting, OEHHA agreed to extend the public comment period to July 17, 2008.

Intellectual Property Bill Moves In Assembly
Despite concerns raised by CHI in a hearing on Tuesday, June 17, the Assembly Health Committee unanimously approved SB 1565, authored by Senators Sheila Kuehl (D-Santa Monica) and George Runner (R-Antelope Valley).  A hearing in the Assembly Judiciary Committee is scheduled for Tuesday, June 24.  The legislation would codify intellectual property (IP) policies at the California Institute for Regenerative Medicine (CIRM) that would establish certain pricing and access requirements as a condition for receiving or licensing grants from the agency.  In 2006 and 2007, CHI submitted a series of comments to CIRM, outlining our position that the basic goal of IP polices should be to minimize barriers to technology transfer and that the pricing and access provisions, that were accepted by the Independent Citizens Oversight Committee (ICOC), would deter industry collaboration.  Despite the inclusion of these requirements, CHI has greater concerns with codifying them into law, because doing so will deny the ICOC the flexibility it may need to amend such policies in the event they prove to be inadequate.  Because of the Democratic and Republican support, albeit for different political reasons, this bill is likely to move through the legislative process.  CHI intends to enter into discussion with the Administration to outline the negative impact the measure will have on future biomedical innovation in California.

UC Provost Resigns as New President Arrives
University of California Provost and CHI Board Member Wyatt “Rory” Hume announced his resignation from the UC yesterday just a few hours into new President Mark Yudof’s first day on the job.  Hume announced that he will continue his career in higher education, but announced no specific plans.