Public Policy News

Linkage Fee Compromise Approved by Council

On October 6th, the San Diego City Council voted 7-1 to approve the latest version of the “linkage fee” compromise. The vote (Councilmember Sherman dissented, Councilmember Emerald was absent) follows months of direct negotiations between the Jobs Coalition (of which Biocom is a founding member) and the San Diego Housing Commission. We are pleased with this version, as it contains an exemption from the increase for Research and Development construction, a gradual phase-in of the fee increase, and a strong regulatory reform package.

The compromise, led by Councilmembers Cole and Gloria, includes:
•    Beginning January 1, 2015, raise the linkage fee 100% over the course of 3 years (annual increase of 33.3% to restore the fee back to its original 1990 level)
•    Full exemptions for warehouse, manufacturing and non-profit hospital construction
•    Exemption from the increase for Research and Development construction (R&D will continue to pay the fee at its current rate of $0.80 per square foot)
•    Removal of the municipal code language that requires the San Diego Housing Commission to bring forward a suggested linkage fee increase on an annual basis in accordance with a construction cost index
•    Direction from the City Council to Mayor Faulconer’s office to bring forward a regulatory reform package to streamline the development process for all housing types – affordable and market rate – to drive down the cost of housing
•    Direction from the City Council to the Housing Commission to bring forward an improved and strengthened linkage fee waiver process for high-wage employers

The full memo is attached. At the hearing, Biocom staff spoke in support of the compromise, and specifically thanked Councilmember Cole for her leadership on improving the waiver process. Biocom looks forward to continuing discussions to make sure the reforms are implemented, and alternative sources of funding for affordable housing are explored and identified.

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What to Expect From Congress After the Elections

Congress returned from a five-week summer recess only to adjourn three weeks later to allow Senators and Members of Congress to return to their hometown for a last round of campaigning before the November 4th mid-term elections. During this short session, the House and the Senate managed to pass a continuing resolution (CR) that will fund the federal government until December 11th. The CR funds all federal agencies and programs at last year’s levels but contains some extra funding – “anomalies” - to contain the Ebola outbreak in West Africa and train and equip Syrian rebels against the Islamic State, also known as ISIS or ISIL.

The top priority for Congress in the lame-duck session will be to pass a new CR or omnibus spending bill to provide federal funding for the remainder of Fiscal Year 2015. The House and the Senate will also have to reach a tax extenders compromise to reauthorize tax incentives that expired at the end of 2013, including the R&D tax credit and biofuels tax credits, which Biocom strongly supports.

Events transpiring outside of the U.S. are likely to significantly affect the lame-duck agenda. In addition to holding hearings on Ebola, Congress is likely to consider legislation to provide relief overseas and protect public health domestically. Congress also awaits details from the Administration on how they plan to ensure the safety of U.S. military personnel deployed in West Africa before fully granting the Pentagon’s request to shift $1 billion for Ebola containment efforts. Congress may also consider additional provisions to fight ISIS in the Middle East or address the political crisis in Ukraine.

Whether Democrats will retain the Senate or whether the Republicans take control will influence the course of actions in the lame-duck session.  Landmark bills such as immigration, tax, and patent reform will not be addressed this year.

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State Legislature Adjourns for 2014; Successful Year for Life Sciences

The state legislature is now adjourned for the year, and once again Biocom had an incredibly successful year at the state level.  This year, Biocom took support positions on 16 bills, and opposed 9. Of these, 6 were high priority for staff and Biocom’s contract counsel.  All 6 high priority bills had favorable outcomes for Biocom’s membership (defeated or amended sufficiently so Biocom removed its opposition).  Once again this year, no bills were signed into law that were opposed by Biocom; in fact, none even got to the Governor for his signature.

Major victories came on bills opposed by Biocom having to do with unnecessary food labelling of products derived from a genetically modified source, prescription and sharps takeback schemes which sought to place all financial and logistical responsibility on manufacturers, and a bill which would have shut down companies in California doing important research on salmon and trout species. A more comprehensive report can be found in the Public Policy section of the Biocom webpage.  Barring an unforeseen special session, the legislature will be in recess until its new class is sworn in on December 1, 2014.

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From FDA: New CDER SBIA Web-Based Learning Course: Engaging with the FDA During New Drug Development

CDER SBIA is pleased to announce the launch of the web-based learning course, “Engaging with the FDA During New Drug Development” as part of our Small Business and Industry Education Series.

This course focuses on familiarizing small pharmaceutical business and industry with resources available to communicate with FDA, and providing guidance on effectively interacting with FDA throughout the new drug development process.  Throughout this course, we discuss:

-       Paths of contact to engage with FDA

-       The impact of formal meetings with FDA

-       Types of formal meetings with FDA

-       Questions to ask during formal meetings with FDA

-       How to submit a meeting request and meeting package

-       Tips for productive meetings with FDA

(Continue reading)

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