In December, Congress passed a combined omnibus appropriations & tax extenders package that included Life Science Washington’s top Federal policy priorities.
Notably, the package includes a 2-year suspension of the medical device tax, NIH funding at the $32 billion level, as well as additional funding for the FDA. The final package also made the Federal R&D tax credit permanent, included provisions for second generation biofuels, as well as some capital gains and capital depreciation provisions.
Below is a summary of the key provisions in each bill that impact the life science industry:
Summary of Relevant Sections in the Omnibus
National Institutes of Health (NIH): The bill includes a program level of $32 billion for the NIH, $2 billion above the 2015 enacted level. It includes specific increases for Alzheimer’s disease research, brain research, antibiotic research, and the Precision Medicine Initiative. Plus, it provides a general increase to all NIH Institutes and Centers to continue basic bio-medical research and translational research through programs like the Clinical and Translational Science Awards and Institutional Development Award program to help scientists discover cures.
Food and Drug Administration (FDA): The FDA receives a total of $2.72 billion in discretionary funding in the bill, an increase of $132 million over the fiscal year 2015 enacted level and $14 million below the President’s budget request. This is roughly $90 - $100 million above the House and Senate committee bills passed earlier this year. Total funding for the FDA, including revenue from user fees, is $4.68 billion. Within this total, food safety activities are increased by $104.5 million, and various medical product safety activities – including additional funds for the Combating Antibiotic Resistant Bacteria initiative, orphan product development grants, foreign high-risk inspections, and precision medicine – are increased by over $24.3 million.
Public Health Preparedness and Response:
· Biomedical Advanced Research and Development Authority (BARDA) received $511M and includes moneys for Combating Antibiotic-Resistant Bacteria (CARB).
· BioShield Special Reserve Fund (SRF) received $510 million, an increase of $255 million above FY2015.
· Strategic National Stockpile (SNS) received $575M.
· Pandemic Influenza received $72M.
· Medical Countermeasures Inactive (MCMi) – received $25M.
340B Drug Program: HRSA is requested to provide a briefing to update the Committees on Appropriations of the House of Representatives and the Senate on the status of 340B guidance, the secure website, and covered entities in the 340B drug program. The proposed user fee was dropped.
Genomic Editing: This provision prevents FDA from reviewing applications related to genome-editing tools to modify the DNA of human embryos – the human germline – until “serious and unquantifiable safety and ethical issues can be resolved”.
Summary of Relevant Sections in the Tax Extenders
Research and Development (R&D) Tax Credit: The R&D Credit was made permanent. In addition, it was expanded to pre-tax startup companies by allowing them to use the R&D Credit against their payroll tax liability.
Medical Device Tax—The tax will be suspended for 2016 and 2017 (1/1/16 to 12/31/17).
Second Generation Biofuels Production Credit: The production tax credit for second generation biofuels was extended for two years (1/1/15 to 12/31/16).
Special 50 Percent Bonus Depreciation Allowance for Second Generation Biofuel Plant Property: The 50 percent bonus depreciation incentive for second generation biofuel plant property was extended for two years (1/1/15 to 12/31/16).
Controlled Foreign Corporation (CFC) Look Through Treatment: The CFC look through treatment was extended for five years (1/1/15 to 12/31/19).
Bonus Depreciation: The broad 50 percent bonus depreciation incentive was extended for five years under a phase-out schedule. Property placed in service in 2015, 2016 and 2017 can take 50 percent. Property placed in service in 2018 can take 40 percent. Property placed in service in 2019 can take 30 percent. Bonus depreciation will not be available in 2020 and later.
Capital Gain Exclusion for Small Business Stock: The 100 percent exclusion of the capital gain on certain qualified small business stock was extended for two years (1/1/15 to 12/31/16).
Throughout 2016, Life Science Washington will focus on smaller, personal engagements with legislators and policy makers. This approach will include several key elements such as roundtable discussions with policy makers and direct conversations with legislators.
Over the course of the year, we will be hosting a series of intimate roundtable discussions with key legislators. Often, these discussions will be paired with a facility tour, which gives policy makers a chance to better understand the incredible work our members are doing to impact people’s lives. During the legislative session, we will focus on facilitating personal conversations between industry executives and legislators at key times during the session.
To help us implement this more personal approach, please send us an email if you have a personal relationship with a member of the legislature so that we can include you in those conversations. Likewise, if you or your company would like to host a roundtable discussion at your facility, please let us know and we will get in touch with you to coordinate the details. Life Science Washington will handle everything! You just need to do what you do best — show how your company is developing products that improve people’s lives!
If you would like to be part of this year’s engagement strategy, please email Marc Cummings, your VP of Public Policy & External Affairs at firstname.lastname@example.org
Drug Pricing is in the News; Here's What You Should Know
Recently, news and political discourse about the healthcare and pharmaceutical industry has been dominated by discussions about the cost of drugs. As we enter a Presidential election year, it is likely that drug costs and pricing will continue to be front and center. While WBBA members are more likely to be pre-revenue companies in the process of developing innovative cures and therapies, rather than actively selling a FDA-approved drug, the debate about drug pricing has the potential to dramatically impact the investment environment and availability of private capital for all biotechnology companies and research organizations.
To address this issue, the Biotechnology Industry Association (BIO) recently drafted a white paper designed to help people better understand the innovative work we do and the risk that is undertaken to bring life-saving cures and innovative therapies to market.
If you are interested in receiving the full white paper titled, “Unleashing the Next Generation of Biotechnology Innovation,” please email email@example.com. Likewise, if you have comments or feedback please let us know.
WBBA Welcomes Marc Cummings
The WBBA is excited to welcome Marc Cummings as our new Vice President, Public Policy & External Affairs. Marc is a seasoned policy veteran with experience representing high-tech industries in both Washington, DC and Olympia. Marc is not new to the WBBA. He served on Life Science Washington’s Government Affairs Committee while at Pacific Northwest National Laboratory (PNNL).
Prior to joining Life Science Washington, Marc launched and served as CEO of a new, non-profit organization called the Smart Building Center. Prior to launching the Smart Building Center, Marc served as Director of Policy & External Affairs for the PNNL, which is operated by Battelle for the U.S. Department of Energy (DOE). His responsibilities included external relations, legislative affairs, regional partnerships, and corporate philanthropy. While at the PNNL, Marc was actively involved in creating and advocating for several statewide bioscience initiatives including the Life Sciences Discovery Fund and a new State-Federal bioproducts and biofuels research center at WSU Tri-cities. Due to Battelle’s philanthropic focus on math & science education, Marc was also deeply involved a range of science, technology, engineering, and math (STEM) education partnerships and science education initiatives.
Marc has over 20 years of policy experience at both the federal and state level supporting the growth of high-tech industries and creating innovative, public-private partnerships. He has served on a number of boards in Washington State including the Washington Technology Industry Association (WTIA) and the Washington Clean Technology Alliance (WCTA). In 2009, he was appointed by Gov. Gregoire to Co-Chair the Washington State Clean Energy Leadership Council. He also served as Interim Director of the Washington State Economic Development Commission.
Marc began his career in Washington, DC, where he held a variety of senior policy and consulting positions including: Director, Federal Government Affairs for CGI-AMS; Director, Public Sector Consulting at Infotech Strategies. He also served as a Senior Advisor at the U.S. Department of Commerce.
Marc holds a M.S. degree from the Georgia Institute of Technology (Georgia Tech) and a B.S. degree from the University of Puget Sound. Mr. Cummings lives in Kenmore, WA with his wife Angela and two sons. He is an avid water skier and tennis player.
Marc will be responsible for Life Science Washington’s federal, state, and local government relations as well as developing partnerships and facilitating strategic engagement with organizations that support the development of Washington’s life sciences ecosystem. If you are interested in learning more, please contact Marc Cummings (206-456-9566) today.
Add Your Voice
Advocacy is a powerful tool. Grassroots action can make all the difference on certain policy issues at every level of government. If you are willing to participate, please contact Marc Cummings (or at 206-456-9566).