Jennifer Nieto Carey,
CLSA’s seasoned federal government relations team is engaged on behalf of the biomedical, agriculture, and industrial biotechnology sectors in multiple ways through strategic collaborations and direct lobbying in Washington, D.C. to advance innovation, investment and job creation for California’s treasured life sciences ecosystem.
The CLSA Federal Legislative Committee (FLC) is engaged on behalf of the life sciences, agriculture, and industrial biotechnology sectors in multiple ways through strategic collaborations and direct lobbying in Washington, D.C. The FLC has identified the policy items in this section as pertinent to CLSA missions and objectives. The FLC meets monthly to discuss and develop positions and activities regarding federal legislative and regulatory issues of importance to our membership. The FLC also plays an integral role in the development of CLSA’s federal policy, education, and advocacy agenda.
Biomedical Research and Education
The continued vibrancy of the California and U.S. biomedical industry relies upon continued advances and progress in science that are fueled and driven by the NIH and other federally-funded science research. Public and private investment in basic research, engagement between NIH and investors and commercialization partners are critical for accelerating basic research and biomedical innovation and bringing new technologies to patients faster. CLSA continues to support efforts to bolster NIH and other science research funding, as the critical foundation of the biomedical R&D ecosystem. We also support efforts to fund important biodefense and pandemic research, development and procurement, and work to highlight the importance of science and math (STEM) education and policies that attract the best and brightest minds from around the world to support the biomedical industry’s continued and sustained vibrancy.
Life sciences research is extremely expensive, and attracting investment into companies developing the next generation of treatments, therapies, and technologies depends on a strong, reliable patent system.
The life sciences industry in California consists of both relatively small, entrepreneurial, and venture capital-backed firms that have yet to bring products to market, and established pharmaceutical, biotech, and device companies with products on the market that enhance, improve and save patient lives on a daily basis. Patent rights and the ability to legitimately enforce them against bona fide infringers is what incentivizes companies large and small to engage in the high-risk, high-cost R&D that makes the discovery, development and commercialization of life-saving medicines possible.
Throughout the 114th Congress, CLSA actively participated in opposing the so-called Innovation Act (H.R. 9), legislation that would threaten the ability of biomedical innovators to enforce their patents and fund continued R&D by inadvertently making it more difficult, time-consuming and expensive to enforce legitimate and important IP rights – and succeeding in halting its momentum to the floor. In the 115th Congress, CLSA advocates to ensure that any proposed solutions to addressing “patent trolls” represent the full spectrum of different industries and sectors reliant on a well-functioning U.S. patent system and the enforcement mechanisms it provides, including California’s innovative biomedical R&D community.
FDA Regulatory Policies, Processes and Funding
History shows that a well‐funded, science‐based FDA and consistent, predictable and transparent product review processes are critical to and necessary for biomedical investment, innovation and improvements in patient care. It is the technical strength of the Agency and the clarity of its regulatory processes that helped the United States – with California front and center – become the global leader in medical device, pharmaceutical and biotechnology innovation. CLSA advocates for adequate and full funding of FDA – through both congressional appropriations and industry-supported user fees – so that the agency may meet its Congressionally-mandated product review responsibilities, as well as sustain biomedical investment, innovation and improvements in patient care.
CLSA supports policies that promote life sciences innovation by enhancing industry-Agency communications, regulatory process, strengthening Agency performance reporting requirements, and improving product review process predictability, consistency and transparency.
Government Coverage and Reimbursement Policies
The ability for products to receive timely and appropriate coverage and reimbursement is critical to drug, device and diagnostics innovation and patient care, and is a top priority area of focus for CLSA. Our federal policy and advocacy work focuses on illustrating the value that biomedical innovation brings in helping address highly costly and challenging public health challenges, by improving patient care and reducing costs to the overall healthcare system. CLSA also works to educate Members of Congress on the success of the Medicare program and the consequences to innovation and patient care that would result from proposals to weaken the program.
Many states and localities have entered the national discussion on GMO food labeling by supporting mandatory labeling legislation, needlessly undermining consumer confidence in the safety of the U.S. food supply, and threatening to greatly harm the bioagricultural industry. In 2016, as in years past, CLSA advocated for federal solutions that inform consumers, affirm FDA as the nation’s authority on food safety, and eliminate the confusion and uncertainty created by a patchwork of GMO labeling laws.
Last summer, President Obama signed into law the Safe and Affordable Food Labeling Act, legislation that will require the nationwide labeling of GMOs in packaged foods. It also provides for a two-year delay of implementation, in order to design and implement the program at USDA. CLSA supported this compromise legislation, as it solves the state-by-state labeling challenge by establishing broad preemption over state and local GMO labeling laws while also providing consumers with reliable information under the direction of USDA without stigmatizing agricultural innovation. CLSA looks forward to monitoring the implementation of this law during the 115th Congress as well as advocating against proposals that would require mandatory labeling of GMO foods.
Industrial & Environmental Biotechnology
Advanced and cellulosic biofuels companies are making discernible progress in bringing innovative clean fuels to consumers. The Renewable Fuels Standard (RFS) provides the policy foundation for investment and research and development in the biofuels industry and maintaining it continues to be the chief policy concern for CLSA’s industrial and environmental member companies. CLSA supports proposals to create RFS stability, and include renewable chemicals and biobased products in biofuels tax credits.
Tax and Fiscal Environment
Sound tax policy can greatly influence life sciences investment, innovation and job creation — and enhance global competitiveness — by providing companies with important incentives to make high-risk investments, leading to the development of innovative, life-saving therapies and medical technologies.
Tax policy serves as a complicated and growing burden on companies competing in the increasingly interconnected global economy. Issues ranging from the U.S.’s near-world high corporate tax rates, and a punitive excise tax on medical technologies at a time when we need more, not less, investment and innovation are just a few of the examples of the challenges and frustrations we face. For emerging companies, the challenges are even more direct — venture capital and other investment dollars to start-up firms have been drying up, meaning that these entrepreneurial firms are struggling simply to keep their doors open, and many promising drug research programs are being put on hold or cut altogether, affecting jobs and, most important, the development of new medicines and treatments for patients in need.
CLSA is strongly supportive of the continuation of programs like the R&D Tax Credit, and the Orphan Drug Tax Credit that provide important incentives to help ensure that promising research and development efforts can continue. As discussions over comprehensive tax reform intensify, it will be critically important for policymakers to consider and incorporate proposals that recognize the unique challenges facing innovative life sciences companies today.