Administration’s Entry Clouds Future of Pedigree Legislation
Prospects for passage of SB 1307, authored by Sen. Mark Ridley-Thomas (D-Los Angeles), became cloudier last week as the administration introduced language that would exclude electronic pedigrees for products sold in the “accredited distribution chain.”  Given the author’s disapproval of the administration’s proposal, it seems less likely that legislation will be approved and signed into law this year.  The bill, without the administration’s amendments, was approved by the Assembly Business and Professions Committee on a party-line vote on Tuesday and will now move to the Appropriations Committee.  CHI testified at the hearing, calling for strong preemption language that would require any system created in California to conform to federal standards when it is adopted.  CHI has entered into this debate in Washington, educating policymakers on the needs of industry while highlighting the need for a strong national standard.  For more information, contact Sandra Pizarro, CHI vice president of state government affairs (916-233-3497 or pizarro@chi.org).

Health Committee Approves Inadequate Medical Waste Collection Bill
On Wednesday, June 25, the Senate Health Committee approved AB 501, authored by Assemblyman Sandre Swanson (D-Oakland), legislation that 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 Web site 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 (FDA) 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 is actively opposing this measure because it is unreasonable to suppose that individuals who fail to comply with that law will alter their behavior because another law is passed.  In addition, the bill only covers the collection of certain types of medical sharps products and does not provide a comprehensive solution for medical waste disposal.

Stem Cell Supplier Policy Moving on Parallel Tracks
The Independent Citizens Oversight Committee (ICOC) of the California Institute for Regenerative Medicine (CIRM) is likely to make a decision today on interim language defining a “California Supplier” that will establish eligibility criteria for companies supplying goods and services to CIRM grantees.  In the voter-approved statute (Proposition 71) there is an explicit preference that grantees must, to the extent reasonably possible, purchase 50 percent of their goods and services from California suppliers.  The ICOC released revised language on Wednesday, following a 30-day public comment period.  CHI has yet to take a position on this language.  The issue is also moving on a parallel track in the State Legislature, where the Senate Health Committee approved it on Wednesday.  CHI testified at that hearing in support of the language in AB 2381, authored by Assemblyman Gene Mullin (D-San Francisco).  CHI intends to convene a group of interested members in the near future to work on language that may address the needs of CHI’s entire membership.  If this is of interest to your organization or for more information contact David Burt, CHI legislative director (858-551-6677 or burt@chi.org).

Animal Research Protection Legislation Stripped
At a hearing on Wednesday the Senate Judiciary Committee approved AB 2296, authored by Assemblyman Gene Mullin, legislation relating to the protection of animal researchers.  Due to disagreements among Senate and Assembly Judiciary staff as well as the author, the bill was stripped down to intent language in order to move the bill and create more time for ongoing negotiations.  A major issue with the language is how broadly the definition of “animal enterprise” is covered for protection under the bill.  CHI believes, as is covered in federal law, that limitations on protections of researchers should not be based solely on whether the institution is academic/industry or public/private.

Report Reinforces California’s Struggles in STEM Education
Despite being home to some of the largest biomedical and high-tech clusters in the U.S., California is loosing its preeminence as one of the leaders in economic growth potential from technology and science according to a recent report by the Milken Institute.  The state slipped from second (behind Massachusetts) to fourth, now trailing such states as Maryland and Colorado.  The rankings are based on a state’s entrepreneurial environment, its population of tech-savvy workers, its commitment to education and other programs that plant the seeds for innovative growth.  California’s stature is diminishing largely due to significant issues within its education system and its ability to produce and retain highly skilled engineers and scientists.