CLS engages on Federal policy and regulatory items in accordance with the legislative priorities and recommendations of our membership including direct lobbying in Washington, D.C., position and coalition letters, comments and testimony.
Research: Biomedical Research & Education
The continued vibrancy of the California and U.S. biomedical industry depends on many factors, but at its very foundation, it relies upon continued advances and progress in science that are fueled and driven by the NIH and other federally-funded science research. We also know that new models for public and private investment in basic research, and earlier 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 join efforts to fund important biodefense and pandemic research, development and procurement, including through the upcoming reauthorization of the Pandemic All-Hazards and Preparedness Act (PAHPA). In addition, we work to highlight the importance of science and math (STEM) education and pro-business immigration reform to support the biomedical industry’s continued and sustained vibrancy.
Regulation: FDA Policies & 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. None of this would be possible without adequate funding of the Agency – through both congressional appropriations as well as industry-paid user fees.
CLSA advocates for adequate and full funding of FDA 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 biomedical innovation by enhancing industry-Agency communications, strengthening Agency performance reporting requirements, and improving product review process predictability, consistency and transparency. CLSA also leads efforts to develop data-based analyses intended to be used by FDA and Congress to further refine and improve the regulatory process, both through legislative action in the next round of user fee negotiations and FDA’s own administrative changes. We also continue to focus efforts on ensuring appropriate and transparent implementation of the regulatory pathway for the approval of biosimilar products established by the Biologics Price Competition and Innovation Act (BPCIA) in 2010, including related biological product payment schemes, and bolstering awareness of and support for the Orphan Drug Act, to continue facilitating the development of orphan drugs for rare diseases.
Reimbursement: Coverage, Payment, Access & Value
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. In particular, our policy and advocacy work focuses on illustrating the real value that biomedical innovation brings in helping address highly costly and challenging public health challenges, by improving patient care and reducing short- and long-term costs to the overall healthcare system. More broadly, CLSA works to inform and educate delegation members on the success of the Medicare program and the consequences to innovation and patient care that would result from proposals to weaken the program – such as such as expanding rebates to dual eligibles, and allowing the government to negotiate pricing (Part D), and/or changing the market-based Average Sales Price (ASP) system (Part B). We also advocate in support of needed reforms to enable value-based health care models, such as through reforming the Federal Anti-Kickback Statute and Physician Self-Referral (“Stark”) Law.
Tax, Trade and Intellectual Property Incentives for Innovation
Sound tax, IP and trade policies 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. CLSA prioritizes advocating on behalf of companies competing in the increasingly intertwined and interconnected global economy as well as emerging companies, for whom the challenges are even more direct. CLSA is involved in or leading efforts to incentivize innovation, including: supporting legislation to fully repeal the medical device excise tax; leading and joining efforts to communicate and contextualize industry consensus positions around particular tax reform proposals, including but not limited to supporting the Orphan Drug and R&D Tax Credits; supporting the use of priority review voucher programs as incentives for investment in therapies for rare pediatric diseases and material threats/medical countermeasures; monitoring and responding as necessary to proposals adjusting 12-year biologics exclusivity period; opposing proposals to weaken U.S. patent laws and rules that would undermine patent certainty and make patent enforcement more cumbersome and expensive; and, addressing concerns with countries, such as India and China, which routinely flout and abuse international IP rules around piracy, compulsory licensing and pricing.
Agricultural, 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. To this end, CLSA supports proposals to create RFS stability, and include renewable chemicals and biobased products in biofuels tax credits.
With respect to agricultural biotechnology, 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. CLSA advocates 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.