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Federal Advocacy

Advocating for a Greater Life Science Future

Federal Policy Priorities

Agriculture and Industrial Biotechnology
Agriculture and Industrial Biotechnology

Energy programs

In December 2018, Biocom applauded the enactment of the Agriculture Improvement Act of 2018, also known as the Farm Bill, which funds agricultural and food programs in five-year increments, including the Energy Title, which supports the development and production of biobased products, renewable chemicals, and advanced biofuels. The law provides mandatory funding for the Energy Title, as advocated by Biocom, ensures eligibility for renewable chemicals and biobased products, and improves the BioPreferred Program. Biocom will work with Congress and the Administration to ensure proper implementation of the Farm Bill.

Renewable Fuel Standard (RFS)

Biocom will continue to support preserving the RFS and oppose any attempts to weaken or eliminate it. The RFS has enabled the development of advanced and cellulosic biofuels and helps support continued investment in these innovative technologies, which in turn helps reduce our dependency on foreign energy sources, generates economic activity, creates jobs, and protects the environment.

E Food Labeling

In July 2016, Congress passed and the President signed into law legislation that created limited mandatory disclosure requirements for genetically engineered (GE) foods. While Biocom supports voluntary food labeling that communicates science-based information relevant to health, safety, and nutrition to consumers, we will work to ensure the proper implementation of the law so that it does not discriminate against GE foods and mislead consumers.

Basic Research
Basic Research

By supporting basic research, the National Institutes of Health (NIH) provide a critical foundation of knowledge that drives private biomedical investment and innovation across the country, and especially in California. In FY 2019, California received $4.5 billion from NIH, which has funded over 8,300 grants. Among those, Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants have allowed small businesses and start-up companies to bring innovative ideas to commercialization.

While NIH funding remained flat for a decade, causing the agency to lose nearly 25 percent of its purchasing power, Congress recognized the importance of NIH funding and has continuously increased its budget these past years to: $32 billion in FY2016, $34 billion in FY2017, $37 billion in FY2018, $39 billion in FY2019, and $41.7 billion in FY2020. In December 2016, Congress passed the 21st Century Cures Act, which added dedicated funding for major research initiatives, including the Precision Medicine Initiative, BRAIN Initiative, and Cancer Moonshot. Biocom highly welcomed these funding increases and urges Congress to continue to increase NIH funding and support NIH initiatives to enable the development of breakthrough treatments and cures and ensure that the U.S. remain the world leader in biomedical innovation.

Biodefense and Pandemic Research
Biodefense and Pandemic Research

The recent coronavirus outbreak, and before it those of Ebola, Zika, and influenza, have revived a nationwide debate over U.S. preparedness for emerging infectious diseases and emphasized the need for robust public-private partnerships and increased funding and support for the research and development of vaccines, diagnostics, therapeutics, and medical devices that can prevent, diagnose and treat emerging infectious diseases in a safe, effective, and timely manner.

Particularly related to the Covid-19 pandemic, Biocom is currently advocating for:

  • Regulations from the Centers for Medicare and Medicaid Services (CMS) ensuring that Medicare beneficiaries can received Medicare Part B infused drugs in the home setting, instead of having to go to a hospital during the covid-19 pandemic. Patients receiving infused drugs are already very vulnerable and cannot afford to forego treatment or risk contamination;
  • Continuity of the life science supply chain. In particular, we oppose “Buy American” orders, which could delay the development of COVID-19 vaccines, therapeutics and diagnostics, and worsen shortages of critically-needed medicines. Indeed, our industry needs access to international supply chains as the U.S. does not produce all of the raw materials and intermediate goods needed for the development of life science products. We are also monitoring legislation that could disrupt the U.S. supply chain and impose greater requirements on manufacturers such as price controls.
  • Sustained funding for the Small Business Administration (SBA)’s Paycheck Protection Program (PPP) enacted by the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Economic Injury Disaster Loan (EIDL) program to help small companies retain their employees and pay their expenses throughout the pandemic, respectively;
  • Clarification that small businesses with equity investors will be eligible for PPP loans. Without clear guidance, small businesses with equity investment – which is the case for most startups- may be rendered ineligible for emergency relief funding and have to lay off workers and shut down critical research;

Biocom also continues to monitor the implementation of the Pandemic and All-Hazards Preparedness Act (PAHPA), enacted in June 2019. PAHPA funds the Biomedical Advanced Research and Development Authority (BARDA), which provides industry partners with funding and technical assistance in the advanced research and development of medical countermeasures (MCMs) for chemical, biological, radiological and nuclear (CBRN) threats, pandemic influenza and other emerging infectious diseases, and Project BioShield which helps accelerate the research, development, purchase, and availability of MCMs.

FDA Regulatory Policy
FDA Regulatory Policy

Biocom is dedicated to improving the drug and device review and approval process, communication between industry and the Food and Drug Administration (FDA), and transparency and accountability within the agency. Biocom will continue to monitor and engage on important regulatory matters, such as accelerated pathways for drugs and devices, the use of real-world evidence in the approval process, the regulation of compounded products, combination products, mobile apps and digital health products, cell and gene therapy products, and next-generation sequencing (NGS) tests, among others. Biocom is also expressing concerns to the FDA as the agency devises potential pathways that would lay the foundation for the importation of certain drugs originally intended for foreign markets.

Biocom is particularly committed to working with the FDA during the covid-19 pandemic to help foster the development of safe and effective medical countermeasures and provide regulatory guidance and technical assistance to advance the availability of vaccines, therapies, and diagnostic tests for Covid-19. We are closely monitoring the impact of Covid-19 on drug and device clinical trial programs and are committed to engaging with the agency to provide guidance on how to address issues such as site closures, travel limitations, interruptions to the supply chain for investigational products, adverse events, and potential infection of site personnel or trial subjects.

Biocom also continues to engage with Congress and federal agencies to ensure the proper implementation of the Biologics Price Competition and Innovation Act (BPCIA), which governs the approval of biosimilars; the 21st Century Cures, which improves our innovation ecosystem, from discovery to development to delivery; and the FDA Reauthorization Act (FDARA), which reauthorizes the prescription drug, medical device, generic drug, and biosimilar user fee agreements in exchange for FDA’s commitment to reviewing products faster and meeting performance goals.

Health Data
Health Data

Digital Health

Health care is at the cusp of a sector-wide transformation due in large part to the development of digital health technologies, such as remote patient monitoring, mobile applications and artificial intelligence. Advances in digital health have enhanced the efficiency of health care delivery, enabled better health care resource utilization, and improved patient outcomes across a wide spectrum of diseases. Wearable devices that monitor a wide range of health data such as blood pressure, glucose levels, blood oxygen levels, heart rate, and electrocardiograms, and devices that deliver medicines directly to patients often reduce the need to physically visit a doctor’s office or hospital, allowing patients to receive and transmit health care information instantly in a home setting and be active participants in their care. These technologies, in turn, contain costs, reduce the frequency of visits to medical institutions, and ensure the continuity of care.

Biocom will continue to support reimbursement policies that provide appropriate and inclusive coverage, coding, and payment for new technologies, such as mobile apps, remote patient monitoring and artificial intelligence products, increased use of electronic health records (EHRs) and patient-generated health data, as well as educational efforts to help patients, providers, and caregivers better understand the benefits and usage of digital health.

Data Privacy

As health data is increasingly being used by life science companies to research, test, develop, deliver and monitor products and technologies, it is important to distinguish research companies from traditional consumer data companies when establishing data ownership, privacy, and security frameworks because of their legitimate needs to access and use health care data to advance public health.

Biocom supports patients being entrusted reasonable ownership rights over their health information but believes that it is highly important to exempt biomedical research from such frameworks, including clinical trials, non-interventional research such as observational drug comparative effectiveness and drug safety studies, and real-world evidence, to ensure the validity and integrity of research and post-market surveillance activities and avoid losing data, adding uncertainty, and creating compliance and financial burdens that would make it more difficult for innovators to do business and improve and save lives. For example, allowing patients to access their clinical trial data would fundamentally impair the integrity of the study results as most clinical trials are blinded (i.e. the participant – with their informed consent- is not told certain information) in order to reduce or eliminate conscious or subconscious bias.

As new data privacy legislation is developed, it is important to keep in mind existing frameworks for the regulation of health data and ensure that existing and new frameworks are harmonized and certain entities and data already covered by existing laws are exempt. In addition, as more state legislatures consider privacy laws, it is crucial to enact federal legislation that seeks meaningful preemption of state law. A lack of harmonization between existing and new frameworks and between state laws would create uncertainty and widespread disruption to the healthcare system and biomedical research.

Intellectual Property and Trade
Intellectual Property and Trade

Intellectual property (IP) is the cornerstone of life science innovation. Strong, predictable IP rights incentivize innovators and their investors to assume the risky investment of time and resources necessary to develop breakthrough medicines. It takes 10 to 15 years and $2.5 billion on average to bring new products to market and approximately 90 percent of all clinical trials ultimately fail. Patents and exclusivities permit innovators to exclude others from using their invention or charge licensing fees for their invention during the life of the IP protection to enable them to recoup their investments. This delicate system rewards risk-taking innovators and accelerates the pace of discovery while ensuring that breakthroughs are eventually shared for all to use.

Biocom supports measures that protect the constitutionally-guaranteed IP rights of innovators and vehemently opposes legislation that would undermine IP protections and the U.S. patent system by weakening patents, imposing greater requirements on innovators, restricting legitimate patent holders’ ability to assert their IP rights, and increasing litigation risks, while continuing to protect patient care and the advancement of medicine. Undermining the U.S. patent system will be especially detrimental to small companies for which patents are often their only asset and means to attract investors to help them fund their research and development (R&D) activities.

Government Intervention

Biocom strongly opposes legislation that would allow the government to take away innovators’ patent and exclusivity protections, including invoking “march-in” rights or granting “compulsory licenses” to generic or biosimilar manufacturers. Taking away the guarantee that innovators will have a limited time period to recoup some of their R&D costs will result in less investment in life science innovation from both innovators and risk-averse investors. Before the 1980s, countless federal research projects were left on the shelf because there were no incentives to develop the projects. The enactment of the Bayh-Dole Act of 1980 allowed research institutes and universities to pursue ownership of an invention derived from federally-funded research and license it to biotech companies, which allowed patients to have access to products and technologies that would never have been developed otherwise. Allowing federal agencies to bypass innovators’ rights (“march in”) for any reason other than public health emergencies counters the intent of the Bayh-Dole Act.

International Trade Standards

Biocom supports free-trade agreements and other trade deals that uphold U.S. IP protections and level the playing field with foreign countries by bringing them closer to our IP standards and limiting foreign “free-riding” on American innovation. In particular, Biocom supports lengthy data exclusivities for biologics and condemned the removal of a provision in the United States-Mexico-Canada Agreement (USMCA) that included 10 years of data exclusivities for biologics. Biocom is also monitoring IP theft and other abuses from foreign countries, such as India and China, which could damage U.S. leadership in biomedical innovation.

Patient Access to Care
Patient Access to Care

Reference Pricing

Biocom strongly opposes proposals that would impose reference pricing, which allows the government to set U.S. prices for drugs based on the prices paid by other countries. Importing foreign price controls on innovative medicines risk importing access restrictions to these medicines. Patients in countries with price controls have access to far fewer medicines than in the U.S. and have lower survival rates for most cancers. Price controls also delay the launch of new medicines because of the additional time needed by governments and companies to negotiate prices and lead to less research and development, which risks depriving the sickest patients from potential treatments and cures. Biocom opposed H.R.3, the Lower Drug Costs Now Act of 2019, which would reduce by 88 percent the number of drugs brought to market by small and emerging companies in California alone and will oppose similar legislation.

Restrictions to Medicines

Biocom supports reimbursement policies that provide appropriate and inclusive coverage, coding, and payment for biopharmaceutical, medical device, and diagnostic products, and that keep pace with regulatory pathways and approvals, especially for new products and technologies such as gene and cell therapies. Biocom supports lowering out-of-pocket costs for patients, broad patient assistance and insurance designs that ensure that patients have access to the care they need. Biocom opposes restrictions to medicines such as restrictive formularies, increased cost-sharing through specialty tiers, high deductibles and co-pay accumulators, as well as the overutilization of prior authorization and step or “fail first” therapy, among others. These policies interfere with physicians’ decisions and effectively prevent patients from using the treatments that are best suited for their condition, delaying access to needed treatments and allowing diseases to progress, which can have irreversible consequences for patients. Reimbursement systems should reward innovative modes of health care delivery that result in quality improvement and cost reduction.

Medicare Reimbursement

Biocom opposes cuts to Medicare Part B reimbursements to physicians and proposals that would cut the current market-based average sales price reimbursement system for physicians (ASP+6 percent), which has successfully reduced Medicare costs since its inception. Further cuts to Medicare Part B will make it more difficult for physicians to provide critical treatments to the most vulnerable patients and further hinder access to treatments in rural areas. Biocom supports Medicare Part D, the successful prescription drug benefit program covering more than 90 percent of Medicare beneficiaries, and continues to engage in conversations to improve the drug benefit design to ensure that all patients have access to the medicines they need. Biocom is also advocating for guardrails around the Center for Medicare and Medicaid Innovation’s (CMMI) demonstration projects to ensure that the demonstrations are scale-appropriate, voluntary, and transparent.

340B

The 340B Drug Discount Program (340B program) was created by Congress in 1992 with the support of the biopharmaceutical industry to help uninsured and vulnerable patients gain access to affordable prescription drugs. The 340B program mandates that to remain eligible for participation in the Medicaid program, drug manufacturers must provide discounts on outpatient medicines and treatments to select covered entities. Over the years, the 340B program has seen significant growth, surpassing the scope and size that was originally intended by Congress. According to the Government Accountability Office (GAO), the number of participating sites and the number of contract pharmacies have both nearly doubled in just five years (2013-2017). Biocom supports changes to the program that would increase transparency, oversight, and accountability.

Precision Medicine

Precision medicine is an innovative approach to disease prevention and treatment that uses individuals’ DNA to select the most effective therapies for patients, moving from a traditional one-size-fits-all approach to personalized treatments based on individuals’ genetic materials. It holds the promise of revolutionizing the delivery of care as we know it by enabling researchers, providers, and patients to work together to develop more precise, preventive, and individualized treatments. As the cost of healthcare continues to increase, we also look to precision medicine as one way to help develop treatments that are more effective, avoid costly unsuccessful therapies and prevent adverse patient outcomes. Genetic sequencing, still unimaginable a few years ago, has now become one of the most powerful tools in modern medicine.

Biocom supports policies that recognize the benefits of precision medicine, ensure the coverage of next-generation sequencing (NGS) tests, and expand the use and access of genome sequencing for a wide range of patients.

Science, Technology, Engineering and Math (STEM) Education & Workforce
Science, Technology, Engineering and Math (STEM) Education & Workforce

Biocom has consistently supported science, technology, engineering, and math (STEM) education in the United States. The Biocom Institute supports life science innovation in California by creating opportunities for STEM students, teachers, scientists, and life science companies to work together and grow a diverse community of life science professionals.

The San Diego Festival of Science and Engineering aims at inspiring today’s students to become tomorrow’s STEM innovators through a week of educational programming and activities for children of all ages. The Veterans Initiative aims to increase career opportunities in the life science industry for transitioning veterans by providing mentoring and networking connections, while promoting advocacy for veteran employment.

In addition, Biocom will continue to support immigration reform that provides American employers with greater access to the world’s best talents by allocating green cards and H-1B visas to high-skilled foreign graduates and graduates with STEM degrees.

Taxes
Taxes

In December 2017, Congress passed and the President signed into law tax legislation, which reforms our corporate and individual tax codes. Biocom applauded Congress for permanently reducing the corporate tax rate to 21 percent from 35 percent and moving the U.S. to a territorial tax system, where the overseas profits of U.S. companies would no longer be subject to U.S. tax, two provisions that had been top priorities for Biocom. These landmark provisions will help make California companies more successful and competitive at home and abroad. The bill also retained the research and development (R&D) tax credit, which incentivizes companies to invest in R&D and is essential to the sustainability and growth of life sciences innovation.

On the other hand, Biocom had repeatedly expressed concerns about provisions that reduced the orphan drug tax credit from 50 percent to 25 percent and limited State and Local Tax (SALT) deductions for income and property. Biocom will work to ensure that these provisions do not disproportionately disadvantage Californians, advocate for legislation that defend the Orphan Drug Act and amend the limitations on SALT deductions, and continue to support policies that promote research, innovation, and advanced manufacturing, stimulate job creation and economic activity, and sustain America’s global leadership.

Federal Committees

Federal Policy Committee
Federal Policy Committee

Biocom’s Federal Committee addresses legislative issues faced by the life science community of California and serves as a resource for all federal policy-related matters. The committee weighs in on legislative proposals affecting the industry, recommends official positions, shares insight on advocacy matters, and participates in policy events.

 

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Intellectual Property Committee
Intellectual Property Committee

Biocom’s IP committee brings California’s legal and life science communities together through discussion of important intellectual property and patent law issues affecting our members, and serves as a forum to improve working relations between the USPTO and industry.

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Regulatory Affairs Committee
Regulatory Affairs Committee

Biocom’s Regulatory Affairs Committee aims at addressing regulatory and scientific issues faced by the life science community of California. The committee provides insight on legislative and regulatory proposals affecting the industry, recommends official positions, and acts as a resource for the Biocom membership.

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Additional Resources

Federal Legislation of Interest

Contact Information

  • For information on federal policy issues, please contact Laure Fabrega at 202-747-5064.
  • For information on regulatory issues, please contact Brittany Blocker at 202-747-5063.

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