Jennifer Nieto Carey,
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
Together, industry, research universities and institutes, venture capital and the National Institutes of Health (NIH) comprise one of the most successful and important public-private partnerships in our country. For example, in 1973, research led by Herbert Boyer at the University of California San Francisco and Stanley Cohen at Stanford led to the development of recombinant DNA technology. That research, supported by NIH funding, spawned an entire industry — biotechnology — which today continues to grow not only in California, but in states across the country and nations around the world. As we look to the future, we are confident that scientific breakthroughs will lead to similar cases — if the “public” foundational element of the public-private partnership is sustained and strengthened. The continued vibrancy of the California and U.S. biomedical industry depends on many things — such as those issues addressed above. But at its very foundation, it depends upon continued advances and progress in science that are fueled and driven by the NIH and other federally-funded science research. Therefore, it is imperative that Congress safeguard and sustain this critical public-private partnership and resulting improvements in patient care, public health, economic growth and job creation by protecting NIH funding as part of a thoughtful and deliberative approach to deficit reduction.
In September 2011, Congress passed and the President signed into law the America Invents Act (P.L. 112-29). The law represents the most comprehensive changes to the U.S. patent system in more than 50 years. Some provisions of the Act took effect immediately, while others will be implemented over time. CHI will monitor and address implementation efforts made at the PTO.
Overseas threats to IP also increasingly challenge the delicate economic system that has enabled California’s world-class biotechnology and medical device industries to thrive. Every year, the U.S. Trade Representative (USTR) releases a report on intellectual property rights (IPR) and the effectiveness of the United States’ trading partners’ protection of IPR. CHI will continue to work with the USTR, members of Congress, including members of the Congressional International Anti-Piracy Caucus, to protect the rights of U.S. patent holders in future trade agreements, address threats by foreign governments to compulsory license products and counter the growing problem of pirated and counterfeit medicines and technologies. It is estimated that some 18 million Americans work in “intellectual property-intensive” industries; therefore, fighting overseas theft is critical to allow the U.S. to maintain competitive in the global economy.
FDA Regulatory Policies, Processes and Funding
Last year, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA), which not only renewed critical FDA user fees, but instituted new mechanisms and procedures, agreed to by the Agency and industry, to promote biomedical innovation by enhancing industry-Agency communications, strengthening Agency performance reporting requirements, and improving product review process predictability, consistency and transparency. This year, it will be important for Congress to ensure that the law is being properly implemented and, just as important, to ensure the Agency has the funding — through access to the user fees and congressionally appropriated funds — be able to institute all the new improvements included in the measure.
Industry is committed to strengthening its partnership with Congress and the Agency. Indeed a strong, science-based Agency and an efficient, predictable and transparent regulatory process are essential elements of the biomedical innovation ecosystem. CHI will continue outreach, dialogue and communications with the Agency and Congress to identify and promote initiatives and reforms to improve Agency regulatory management and capabilities, including and beyond FDASIA implementation. Additionally, CHI will monitor FDA implementation of the new biosimilars pathway to ensure its adherence to the letter and spirit of the law, which was strongly supported by CHI, as well as regulation of mobile health and related technologies, research-use only proposals, unique device identifier (UDI) policies and other Agency-related matters.
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. That is why it is important to protect programs that are working — Medicare Part D and Part B programs for example — from proposals that would undermine and weaken them. More broadly, in other areas, such as comparative effectiveness research, CMS “coverage with evidence development” policies, and the need for modernized payment mechanisms for advanced diagnostic tests, policymakers must be sure to balance the need for responsible fiscal policy with the importance of protecting and promoting access to innovative medicines and technologies that improve patient and public health. Certain other policies, such as the Medicare Independent Payment Advisory Board (IPAB), fail to achieve this balance and instead favor blunt cost control mechanisms that threaten future innovation and patient care. In addition, numerous Affordable Care Act (ACA) provisions are likely to continue with implementation at the federal and state levels, including accountable care organizations (ACOs) and the exchanges. Finally, the drive towards healthcare decision-making including coverage and payment policies — is likely to continue, making it increasingly important for innovators to participate in efforts to not only identify and shape policy proposals in this area but to develop and communicate a narrative that better contextualizes the issue as part of the broader biomedical R&D ecosystem.
Over the past few years, there has been an increasing amount of attention devoted to labeling of foods containing genetically modified organisms, or GMOs, much of which is due to misinformation intended to scare consumers.Local and state governments across the country have introduced legislation mandating labeling, and Vermont became the first state to pass such legislation in 2014.A federal solution that informs consumers, affirms FDA as the nation’s authority on food safety, and eliminates the confusion and uncertainty created by a patchwork of GMO labeling laws is necessary.
The health and safety of GMO foods is affirmed in scientific studies, by the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture, as well as the world’s leading think tanks, journals, and universities.However, 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 2014, we joined our national partners at BIO and the Coalition for Safe Affordable Food in supporting a federal GMO labeling solution that addresses the concerns of consumers and provides consistency.The proposed solution would mandate labeling of GMO food that presents a health risk or is compositionally different from its’ non-GMO counterpart.It would rely on the U.S. FDA to leverage its’ food safety authority to establish federal standards for companies who want to voluntarily label their products for the absence or presence of GMOs, and require FDA to define terms like “natural” for use on food and beverage products to create consistent legal framework to guide labeling and consumer choice.
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.These companies also aim for establishment of stable tax policy that supports biofuels, renewable chemicals, and biobased products.
Thanks to the RFS, almost $6 billion in private capital has been invested into the advanced biofuels industry.2014 was a watershed year, with the first cellulosic biorefineries in the U.S. beginning operation.The industry has taken these steps to increase capacity to meet annual volume requirements, but the Environmental Protection Agency’s proposed 2014 rule included setting renewable fuel volumes using a different methodology that would effectively lower the targets.Industry concerns over the new methodology has delayed release of final rule, though EPA has said they will release the 2014 rule in early 2015, and release both 2015 and 2016 at the end of this year.It is imperative that the RFS is preserved, as weakening or eliminating it would have sizable impact on this new industry.
The biofuels industry receives a variety of tax credits, but these have not been extended to companies working in renewable chemicals and biobased products.Furthermore, the credits expired at the end of 2014, creating uncertainty and instability for the industry.With California leading the nation in algae platforms and renewable chemical development, inclusion of these areas into the tax code is incredibly important.
Tax and Fiscal Environment
Letters, Testimony and Comments
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, never-ending yearly angst over extension of the R&D tax credit and, most recently, 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. As discussions over comprehensive tax reform intensify, it will be critically important for policymakers to consider and incorporate proposals that recognize these and other challenges.