Biocom - Life Sciences Association of California
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Policy Priorities

Access to water

California is experiencing prolonged drought conditions, and mandatory water cutbacks have been implemented throughout the state. Biocom is in regular contact with stakeholders most affected by this crisis, including the agencies who supply Southern California’s water. They have repeatedly stated that California can achieve its 25% water reduction mandate through curtailment of ornamental and outdoor uses of water; this has been demonstrated since the cutbacks went into effect in 2015. However, if Californians cannot continue to achieve water reduction targets through cosmetic uses, it becomes more likely we will experience mandatory shutoffs, affecting business activities for life science companies.


The Guaranteed Water for Industry Program was adopted by the San Diego City Council in 1998. The city recognized valuable industries such as manufacturing and Research and Development operations are significant water users, and, as these companies are leaders in the implementation of water conservation methods, they need assurances that their mitigation efforts will be taken into account when considering future mandatory conservation measures. This program provides that when such firms implement voluntary conservation measures, they can be exempted from mandatory Level 2 conservation measures in the event of a drought.


Request: The city could increase advertising for the Guaranteed Water for Industry Program, consider alternative measures before implementing mandatory shutoffs to businesses, and continue to support nontraditional water resources.


Biocom Water One-Pager

agricultural and industrial biotechnology
GE Food Labeling
Biocom supports voluntary food labeling that communicates science-based information relevant to health, safety, and nutrition to consumers, consistent with FDA’s current policy. Biocom opposes legislation that imposes strict mandatory labeling standards that would be misleading to consumers.

Energy programs
In February 2014,Biocom applauded the enactment of the Agricultural Act, also known as the Farm Bill, which provides $881 million in mandatory funding for Energy Title programs, includingthe Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program, the Biomass Crop Assistance Program (BCAP), and the Biomass Research and Development Initiative (BRDI), as well as eligibility for renewable chemicals.Farm bills commonly refer to legislation authorizing funding for programs within the U.S. Department of Agriculture (USDA) in five-year increments. Since 2002, Farm Bills have funded energy programs (under “the Energy Title”), which have facilitated the development of biorenewable energy, including biofuels and biobased products. Biocom will continue to work to ensure proper implementation of the programs and advocate against any cuts through appropriation measures.

Renewable Fuel Standard (RFS)
Biocom strongly supports preserving the RFS and opposes 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.
biomedical innovation initiatives
Biocom strongly supports initiatives by the House Energy & Commerce Committee (21st Century Cures), the Senate Health, Education, Labor and Pensions (HELP) Committee (Innovation for Healthier Americans), and the Administration (Precision Medicine Initiative, BRAIN Initiative, and Cancer Moonshot), which all aim at bringing new treatments and cures to patients faster, a top priority for Biocom. The congressional initiatives make much needed changes to our regulatory environment to improve our innovation ecosystem, from discovery to development to delivery. The executive initiatives address some of today’s most pressing challenges in biomedical research by investing in targeted areas.

In July 2015, the House passed a comprehensive 21st Century Cures Act, while in the spring of 2016 the Senate HELP Committee passed 19 measures at the committee level. Together, the House and Senate bills contain many provisions supported by Biocom, including additional discretionary and mandatory funding for the National Institutes of Health (NIH) and Food and Drug Administration (FDA), provisions to enhance efficiency, hiring, and training at the NIH and FDA, improve electronic health records (EHRs), a priority review pathway for breakthrough medical devices, a limited population approval pathway for antibiotics, an expansion of the priority review voucher program for rare pediatric diseases, clear standards for biomarker acceptance and qualification, a pharmaceutical and technology Ombudsman at the Centers for Medicare and Medicaid Services (CMS), as well as provisions to advance the use of modern trial designs and real-world evidence, among others. Biocom worked with the committees to develop language and is currently urging the two Chambers to pass conferenced legislation by the end of the year.
Biomedical research funding

By supporting basic research, the National Institutes of Health (NIH) provides a critical foundation of knowledge and technologies that drive private biomedical investment and innovation across the country, and especially in California. In Fiscal Year 2016, California received $3.6 billion from NIH, which has funded over 7,500 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. However, NIH funding has been flat for the past decade and has not kept pace with inflation, which has resulted in the NIH losing nearly 25 percent of its purchasing power. Decreased investments in innovation discourage talented individuals from pursuing careers in science, drive away early-stage investors, and lead some scientists to other countries to pursue research interests. 

Last year, Congress allocated $32.1 billion to the NIH, an increase highly welcomed by Biocom. But Congress must continue to invest in medical innovation to enable the development of breakthrough treatments and cures. We just cannot allow flat funding to undermine progress in medical research at a time when we are on the cusp of exciting new advances in cancer, infectious diseases including HIV/AIDS, heart disease, diabetes, Alzheimer’s, and many other diseases. Biocom has urged the House and the Senate to fund the NIH at $34.5 billion in FY2017 and to allocate additional mandatory funding for the Institutes. Biocom also supports expanding the set-asides for SBIR/STTR grants. 

In addition, Biocom continues to advocate for biodefense and pandemic research funding. Recent outbreaks, such as Ebola and Zika, have revived a nationwide debate over U.S. preparedness for emerging infectious diseases and emphasized the need for robust public-private partnerships. Biocom supports additional funding for the Project BioShield Special Reserve Fund (SRF), which incentivizes companies to develop medical countermeasures (MCMs), and the Biomedical Advanced Research and Development Authority (BARDA), which develops vaccines and treatments for chemical, biological, radiological, and nuclear (CBRN) threats, through partnerships with industry.

Climate action plan

In December 2015, San Diego City Council approved the city’s Climate Action Plan (CAP) to reduce greenhouse gas emissions by 40% below 1990 levels by 2030 in accordance with state law. The plan seeks to do this in a variety of ways, including through energy and water efficient buildings, clean and renewable energy, increasing transit options, zero waste, and preparing for actual effects of climate change.


Biocom supported approval of the CAP, and applauds the inclusion of cost-benefit analysis of any regulations that are implemented during the next phase of the plan, which will include regulatory language to achieve the targets the plan outlines.


Request: Minimize unfunded mandates for businesses during the implementation of the Climate Action Plan.

digital health
Health care is at the cusp of a sector-wide transformation due in large part to the development of digital health technologies, from genomic testing and sequencing to mobile applications to remote patient monitoring. 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. Digital health technologies often reduce the need to physically visit a doctor’s office or hospital, allowing patients to communicate with their physicians and receive and transmit health care information instantly in a home setting, thus containing costs, preventing the deterioration of conditions, reducing the frequency of visits to medical institutions, and ensuring the continuity of care. Digital health also empowers patients to be active participants in their health care decision-making process.
Biocom supports reimbursement policies that provide appropriate and inclusive coverage, coding, and payment for new technologies, platform-agnostic regulations of digital health technologies, 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 technologies, among others.
intellectual property and patent law

Patent Litigation Legislation
Biocom has vehemently opposed and will continue to oppose legislation that aims at curbing deceptive patent litigation behaviors (commonly referred to as “patent trolls”) by imposing greater requirements and penalties on all patent holders, such as costly pleading and reporting requirements, restrictions on additional discovery requests, and burdensome fee shifting provisions, among others. Such limitations undermine the U.S. patent system by restricting legitimate patent holders’ ability to assert their patent rights and increasing litigation risks, which would in turn lower the value of patent assets and reduce investment in early innovation. 

Several recent and major judicial and administrative developments in patent law have fundamentally changed the landscape under which patent legislation should be considered, and made proposed measures irrelevant or unnecessary. Should Congress resume consideration of such ill-written proposals, Biocom will engage with House and Senate committees and leaderships to find reasonable ways to address abusive practices by specifically targeting bad actors. Biocom will only support measures that protect the constitutionally-guaranteed intellectual property rights of innovators.

USPTO User Fees
Biocom continues to work to ensure that the Patent and Trademark Office (USPTO) has access to the entirety of user fees collected and is advocating against user fee diversion. Over the past twenty years, PTO user fees diversion has led to more than 600,000 unexamined patent applications and more than 28 months in the average patent pendency time. 

Permits and inspections

Biocom supports efforts to make city and county permitting processes transparent and efficient. Inconsistent standards for inspections have been an ongoing issue for our members, and one that we have been working on with government staff for many years. We appreciate efforts to ensure inspections are done consistently and in collaboration with businesses.

prime industrial land

Preserving Prime Industrial Lands (PIL) for manufacturing, research and development, and distribution is vital to regional long-term economic stability and encouragement of industry growth. Land zoning plans are created to provide space between industry and residential to avoid compatibility conflicts. There is a slow erosion of prime industrial lands with by right “limited use” ministerial decisions and “discretionary” conditional use permit decisions by the Planning Commission and City Council, which allow incompatible land uses for new facilities or by extending the presence of existing incompatible uses in prime industrial areas. Since 2011, there have been several discretionary approvals which have removed PIL sites from the PIL land map.


Request: Support community plan updates that preserve Prime Industrial Lands, and prevent incompatible land uses by voting against collocated projects.

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 the agency’s transparency and accountability. Biocom monitors and engages on important regulatory matters on behalf of the California life science community, including the regulatory pathway for the approval of biosimilar products established by the Biologics Price Competition and Innovation Act (BPCIA) in 2010, the regulation of compounded products, mobile apps, laboratory-developed tests (LDTs), Next-Generation Sequencing (NGS) tests, and the new drug tracing and UDI (Unique Device Identification) systems, among others


User Fees Reauthorization

Biocom is advocating for adequate funding of the FDA through congressionally appropriated funds and user fees to ensure that the FDA can review new drugs, biologics, and medical devices in an efficient and timely manner. Biocom supports the full implementation of user fees agreements, including the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), which increase industry-paid user fees every five years in exchange for FDA’s commitment to making critical improvements in such matters as product review and approval processes, communication with companies, accountability and transparency, regulatory science, post-market safety evaluation, and performance commitments. As the current agreement, the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), is set to expire on September 30, 2017, FDA and industry have worked together to draft new agreements. Biocom will work with Congress, FDA, and stakeholders to ensure passage and implementation of industry-friendly agreements. 

Reimbursement and patient access to care

Biocom is committed to ensuring that patients have access to the care they need and supports reimbursement policies that provide appropriate and inclusive coverage, coding, and payment for biopharmaceutical, medical device, and diagnostic products. Coverage and coding limitations, outdated Medicare regulations, restrictive formularies, and increased cost-sharing such as specialty tiers and high deductibles, among others, inhibit both the development of breakthrough technologies and their use by providers, which in turn limits patients’ access to life-enhancing and life-saving products. Reimbursement systems should reward innovative modes of health care delivery that result in quality improvement and cost reduction and, most importantly, save lives. 


Medicare Part B

Biocom has strongly opposed the $3 billion cuts to Medicare Part B reimbursements to physicians mandated by the sequester, and continues to oppose 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 increase the likelihood that physicians will stop providing critical treatments to the most vulnerable patients. Biocom is vehemently opposed to a draft rule proposed by the Center for Medicare and Medicaid Innovation (CMMI) at the Centers for Medicare and Medicaid Services (CMS), which would reduce reimbursement for Medicare Part B products to a combination of a much lower ASP percentage rate and a flat fee.


Medicare Part D

Biocom is opposed to cuts and changes to the Medicare prescription drug benefit program (Medicare Part D), a successful program covering more than 90 percent of Medicare beneficiaries with comprehensive drug coverage. Proposals to impose rebates and price controls to Medicare Part D will likely destabilize the program and decrease industry incentives to invest in new drugs’ research and development.

SANDAG 2050 regional plan

An efficient transportation system is an important part of business attraction and retention. In October 2015, the board of the San Diego regional planning agency voted unanimously to approve a spending plan that will fund transportation projects for the next 35 years. The plan includes transit and freeway expansion, changing land use patterns, plans for sustainability, and economic benefits. SANDAG is considering a ballot measure that would implement the Regional Plan, which would ask voters to increase our local sales tax by up to one-half center. View the plan here.

Request: During implementation of the Regional Plan, transit and road/freeway expansion should receive equal consideration in order to accommodate all types of commuters.

STEM Education

Biocom has consistently supported science, technology, engineering, and math (STEM) education in the United States. The Biocom Institute supports life science innovation in Southern 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 supports 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. 

storm water channel maintenance

Most recently in January 2016, flooding in Sorrento Valley during storm events threatened many businesses, especially along Roselle Street. There are several Biocom member companies located on Roselle Street, and many more throughout the affected area. Floods cause physical damage to businesses and result in lost revenue when workers are evacuated and then businesses are closed for repairs. View the draft brochure here.


Request: Ensure the city regularly clears storm channels and works with State Parks to maintain clearing of Los Peñasquitos.

Biocom is dedicated to improving the drug and device review and approval process, communication between industry and the Food and Drug Administration (FDA), and the agency’s transparency and accountability. Biocom monitors and engages on important regulatory matters on behalf of the California life science community, including the regulatory pathway for the approval of biosimilar products established by the Biologics Price Competition and Innovation Act (BPCIA) in 2010, the regulation of compounded products, mobile apps, laboratory-developed tests (LDTs), Next-Generation Sequencing (NGS) tests, and the new drug tracing and UDI (Unique Device Identification) systems, among others.

  • User Fees Reauthorization

Biocom is advocating for adequate funding of the FDA through congressionally appropriated funds and user fees to ensure that the FDA can review new drugs, biologics, and medical devices in an efficient and timely manner. Biocom supports the full implementation of user fees agreements, including the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), which increase industry-paid user fees every five years in exchange for FDA’s commitment to making critical improvements in such matters as product review and approval processes, communication with companies, accountability and transparency, regulatory science, post-market safety evaluation, and performance commitments. As the current agreement, the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), is set to expire on September 30, 2017, FDA and industry have worked together to draft new agreements. Biocom will work with Congress, FDA, and stakeholders to ensure passage and implementation of industry-friendly agreements. 

Biocom is dedicated to improving the drug and device review and approval process, communication between industry and the Food and Drug Administration (FDA), and the agency’s transparency and accountability. Biocom monitors and engages on important regulatory matters on behalf of the California life science community, including the regulatory pathway for the approval of biosimilar products established by the Biologics Price Competition and Innovation Act (BPCIA) in 2010, the regulation of compounded products, mobile apps, laboratory-developed tests (LDTs), Next-Generation Sequencing (NGS) tests, and the new drug tracing and UDI (Unique Device Identification) systems, among others.

  • User Fees Reauthorization

Biocom is advocating for adequate funding of the FDA through congressionally appropriated funds and user fees to ensure that the FDA can review new drugs, biologics, and medical devices in an efficient and timely manner. Biocom supports the full implementation of user fees agreements, including the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), which increase industry-paid user fees every five years in exchange for FDA’s commitment to making critical improvements in such matters as product review and approval processes, communication with companies, accountability and transparency, regulatory science, post-market safety evaluation, and performance commitments. As the current agreement, the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), is set to expire on September 30, 2017, FDA and industry have worked together to draft new agreements. Biocom will work with Congress, FDA, and stakeholders to ensure passage and implementation of industry-friendly agreements. 

taxes

Tax Reform
Tax reform should promote research, innovation, and advanced manufacturing, stimulate job creation and economic activity, and sustain America’s global leadership. Biocom supports a simplified, lower corporate tax code and a territorial tax system, which would ensure that U.S. companies are successful at home and competitive and attractive on the global stage. Furthermore, the tax code should include incentives to foster private, long-term investments in innovation, especially in high-risk industries and pre-revenue companies.

Tax Extenders
It is also crucial to have a predictable and stable tax system. Temporary tax provisions, always on the verge of expiring, make tax planning very difficult and result in extreme uncertainty for businesses trying to plan for their development. Biocom applauded the enactment of legislation at the end of 2015, which made the research and development (R&D) tax credit permanent and allowed pre-tax startup companies to use the credit against their payroll tax liability. Biocom also supports making renewable energy tax incentives permanent, such as the second generation biofuel producer tax credit, and extending existing investment and production tax credits to emerging products, such as renewable chemicals.

Medical Device Excise Tax
Biocom also applauded the two-year suspension (2016-2017) of the medical device tax. The 2.3 percent excise tax on medical device sales first took effect on January 1, 2013, and has put serious budget constraints on medical device companies. The tax is expected to cost manufacturers nearly $30 billion over the next ten years, putting 43,000 jobs at risk, stifling R&D investments and medical innovation, eroding U.S. global leadership, and jeopardizing patient access to breakthrough devices and therapies. Similar excise taxes are levied by the federal government on products such as alcohol and tobacco to discourage their use. In addition, the tax is assessed on revenue and, therefore, is particularly burdensome for many innovative start-up companies, which are not yet profitable. Fully repealing the medical device tax remains one of Biocom’s top priorities.

Upcoming Public Policy Events
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Jun
27
Los Angeles Area Facilities/EH&S Committee Kickoff
Tuesday
June 27, 2017
12:00 PM
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Jul
18
Joint Biocom/IEA Meeting: Prop 65 Update
Tuesday
July 18, 2017
11:30 AM