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CLSA Wire

Mandatory Reporting Bill Entering Critical Stretch in State Legislature
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May 9, 2016

Problematic legislation we have previously reported on, Senate Bill 1010, continues to make its way through the California Senate.

The bill would require, among other things, a manufacturer to provide a 60-day notice to all payers in California and the chairs of all fiscal committees in the state legislature if the price of a drug increases more than 10 percent in a 12-month period or if a drug will be marketed at an initial price of $10,000 or more annually or per course of treatment.

At 30 days, the manufacturer would be required to submit drug-specific information on “public funding received” (including R&D tax credits), anticipated marketing budget, and a justification of the increase or initial price “including all information and supporting documentation.”

The bill is currently sitting on the Senate Appropriations Committee’s suspense file, meaning it will be held in the committee until potentially significant costs to the state can be addressed. The committee will vote on whether the bill will move on to the Senate floor on May 26 or 27.

CLSA submitted a letter of opposition on the bill to focus particularly on the substantial costs to the healthcare system that it would bring. These costs would be as a result of the bill’s enormous administrative burdens on drug makers, insurers, and the state, among others, as well as a result of the drug shortages that would likely be caused by the bill’s advance notice provisions. You can read these arguments and others in the CLSA letter here.

As part of CLSA’s ongoing value of innovation initiative, we have developed a number of advocacy resources in our efforts to fight this anti-industry bill. New infographics discuss the bill’s likely consequences to biomedical research and development efforts such as the Obama Administration’s Cancer Moonshot effort and outline the complicated chain of players  and processes involved in moving a medicine from manufacturer to patient.

For further information, please contact Brett Johnson, CLSA’s Director of State and Local Government Policy (Bjohnson@califesciences.org).