Senate Bill Would Publicize Clinical Trial Results
Next week the Senate Health Committee will hear SB 606 by Senator Jack Scott (D-Altadena), a measure which would, among other things, require any pharmaceutical company that sells, delivers, offers for sale, or gives away any pharmaceutical drug within California to make publicly available the results of every completed clinical trial that the company has conducted (except a Phase I trial), and any explanation of non-completion for any clinical trial (except a Phase I trial). CHI opposes SB 606 because it is overly broad, inconsistent with current state and federal requirements for clinical trials, does not allow for publication in peer-reviewed journals, and could cause undue delays in submittals to the federal Health & Human Services Agency (HHS).
High Costs Stall Chemical Exposure Legislation
AB 515 by Assemblywoman Sally Lieber (D-Mountain View) was heard this week in the Assembly appropriations committee and placed on the suspense file due to the high costs of implementing the standards outlined in the bill if it was signed into law. The measure would require the Occupational Safety and Health Standards Board (OSHSB) to duplicate its rulemaking for hundreds of chemicals that already have permissible exposure limit (PEL) standards. Additionally, the measure requires the OSHSB to set PEL standards as recommended by the Office of Environmental Health Hazard Assessment (OEHHA); however, no guidelines are provided in the bill. Currently OEHHA does not receive input from industry in making recommendations and CHI is concerned that industry’s participation would be marginalized under the proposed legislation. CHI will continue to work with other industries that are opposed to the measure, coming off the suspense file and moving to the Assembly floor. The appropriations committee considers the suspense file later in May. View CHI’s opposition letter.
CHI Submits Comments on Proposed IP Regulations
On Monday, April 30, CHI submitted public comments to a proposed regulation of the California Institute for Regenerative Medicine (CIRM) entitled “Intellectual Property and Revenue Sharing Requirements for For-Profit Companies.” The IP Working Group of the Independent Citizens Oversight Committee (ICOC) – the governing board of the CIRM -- will consider all the public comments and will allow oral testimony at an upcoming public hearing (not yet scheduled). View CHI’s comments.
CIRM Names Acting President, Interim Chief Scientific Officer
The CIRM announced on Wednesday that Lori Hoffman has been named the agency’s acting president and Arlene Chiu, Ph.D. its interim chief scientific officer. The co-equal appointments will be effective until the Institute’s board – the ICOC – names a replacement for Zach W. Hall, Ph.D. who recently resigned from the ICOC. That replacement is expected later this year. View the CIRM press release.