CHI Meets With Director of Green Chemistry Initiative
On Wednesday, May 7, CHI and representatives from our biotechnology, medical device and diagnostics membership met with Maureen Gorson, director of the Department of Toxic Substance Control (DTSC), to discuss the Schwarzenegger administration’s Green Chemistry Initiative.  At the meeting, CHI submitted a letter to the director that outlined the economic impact of the biomedical community, the rigorous product approval process at the U.S. Food and Drug Administration (FDA), and the essential importance of chemicals in the research and manufacturing of medical technologies.  Also included were responses to questions DTSC had submitted to industry.  The responses, in addition to workshops DTSC has convened, will be the basis for recommendations by the director next week.  On Thursday, May 8, DTSC sent out another formal request to industry for information on “chemicals of concern,” which suggests the process may move slower that originally intended as the department continues to gather information.  As this issue moves forward, CHI will work to protect the interests of the biomedical community.  For more information, contact Sandra Pizarro, CHI vice president-state government affairs (916-233-3497 or pizarro@chi.org).

CHI Opposes Product Liability Measure
On Wednesday, May 7, AB 2690, authored by Assemblyman Paul Krekorian (D-Burbank), liability legislation pertaining to pharmaceutical manufacturers was amended to cover only product with direct to consumer advertising.  In its current form, the bill would declare that a manufacturer of a prescription pharmaceutical product shall not be relieved of a duty to warn consumers of the risks and side effects of that product solely because the product was prescribed by a physician, if that product is advertised directly to consumers.  CHI will continue to actively oppose this legislation, highlighting the doctor-patient relationship and our belief that patients should rely on their physicians’ judgment in choosing an appropriate medicine.  Without the judicial “learned intermediary” doctrine, which would be removed under the bill, patients would have to review complex, highly technical warnings from manufacturers who would be required to communicate with patients directly on the risk of their products.  The bill is eligible to be heard on the Assembly Floor next week.  For more information, contact Sandra Pizarro, CHI vice president-state government affairs (916-233-3497 or pizarro@chi.org).

CHI Supports Task Force on Electronic Pedigree Requirement
On Monday, May 12, the Senate Appropriations Committee will hold a legislative hearing to discuss SB 1270, authored by Senator Gil Cedillo (D-Los Angeles), legislation that would require the California Board of Pharmacy (board) to establish the Electronic Pedigree Task Force and that would require the staff of the board to support its needs.  CHI strongly supports the intent of the current electronic pedigree law and of the board to protect the citizens of California from the threat of counterfeit drugs.  The state’s biomedical industry has been at the forefront of electronic pedigree technology, testing and implementation and there is expertise within our membership that should be utilized in order to effectively implement the law.  Sharing these experiences, in conjunction with other industry stakeholders, will ensure that important information is transmitted to the board on the the supply chain’s capacity to implement an effective system that functions smoothly and without interruption.  CHI submitted a letter to the author and the committee in support of this important legislation.

CHI to Support State Fire Marshal’s Building Standards for R&D Laboratories
CHI is in the process of completing a submission to the State’s Building Standards Commission in support of a proposal by the State’s Fire Marshall to develop and create a new L-Occupancy class that will apply to research and development (R&D) laboratories in the state.  CHI supports the extensive and inclusive process by the State Fire Marshall in the development of the L-Occupancy.  The biomedical industry is an integral part of the state’s growing scientific community that is reliant on a broad range of biological and chemical work conducted in a laboratory environment.  The proposed changes under the new L-Occupancy will help the industry expand in California by facilitating the use of mid- and high-rise buildings for laboratory space, providing improved flexibility in the way hazardous materials are managed.  The Building Standards Commission is challenging the legal authority of the Fire Marshall to issue the proposed changes and is expected to make a final decision at its next meeting this summer.