Federal Policy Priorities

Colorado's bioscience industry is building one of the most exciting and advanced industry clusters in the country. The state is currently home to a thriving industry, comprised of nearly 600 biotechnology, medical device, diagnostic, pharmaceutical, health care providers, research institutions and those businesses that provide critical services and products to bioscience companies. The industry employs over 28,000 individuals creating over 156,000 direct and indirect jobs, translating into over $10 billion in payroll. At the center of this exciting growth is the Colorado BioScience Association (CBSA), shaping the policies and developing the programs to help Colorado's bioscience and medical technology companies grow and prosper.

In this effort, CBSA works closely with national organizations such as the Advanced Medical Technology Association (AdvaMed), Biotechnology Industry Organization (BIO), Medical Device Manufacturers Association (MDMA), and Pharmaceutical Research and Manufacturers of America (PhRMA) to advocate for shared policy objectives to ensure that Colorado companies' voices are heard by federal elected officials. 

Download the Federal Priorities for 2017

2017 Federal Policy Priorities: 

Food and Drug Administration (FDA)

 

Funding: Ensuring the FDA has the resources to keep pace with rapidly evolving biomedical and medical technology development will allow for sound and timely regulatory decisions. CBSA supports policies and efforts to adequately fund the FDA through both appropriated funds and user fees. The FY 2017 Budget Request is $5.1 billion, an overall increase of eight percent or $358.3 million compared to the FY 2016 Enacted level. The budget includes $2.7 billion for budget authority – an increase of one-half of one percent or $14.6 million compared to the FY 2016 Enacted level, $2.3 billion for user fees2 – an increase of twelve percent or $268.7 million compared to the FY 2016 Enacted level, and $75.0 million in new mandatory funding to support the Vice President’s Cancer Moonshot.

User Fee Sequestration: User fees are private monies – not federal taxpayer dollars – and should not be subject to sequestration. These funds are critical not only for FDA to meet its Congressionally-mandated product review responsibilities, but for sustaining medtech and biomedical investment, innovation and improvements in patient care. CBSA supports H.R. 1078, the FDA Safety Over Sequestration Act, which would protect industry user fees paid to FDA from sequestration or other across-the-board spending cuts in future fiscal years. On May 5, 2015 CBSA joined 40 organizations from 30 states in a state sign-on letter to support H.R. 1078, the FDA Safety Over Sequestration (SOS) Act. This provision was included within HR 6, the 21st Century Cures Act, which CBSA supported.

Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA): FDASIA expands the FDA’s authorities and strengthens the agency's ability to safeguard and advance public health by: giving the authority to collect user fees from industry to fund reviews of new products; promoting innovation to speed patient access to safe and effective products; increasing stakeholder involvement in FDA processes; and, enhancing the safety of the drug supply chain. The law increased industry-paid user fees in exchange for the 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. Beginning late 2015, FDA and industry will begin negotiations for the next set of User Fee Agreements which are scheduled to be reauthorized in 2017. CBSA will continue to support the full implementation of FDASIA and will work with industry partners on the negotiations for reauthorization to ensure the industry’s concerns and priorities are met.

Biosimilar Approval Pathway: The Affordable Care Act created an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. As the FDA continues to finalize guidance regarding the regulatory pathway for the approval of biosimilar products, CBSA will advocate for protections on product innovation and allowing originator products to receive 12 years of data exclusivity both in the United States and abroad.

 

National Institutes of Health

 

Funding The National Institutes of Health (NIH) is responsible for research in the study of human health, diagnostics and treatments and helps to maintain the U.S. stronghold as a national leader in the development of biomedical research. The NIH also supports proof-of-concept and early-stage research throughout the country, providing Colorado the largest source of funding for basic research within our university system. As the cost of medical product development process continues to increase, the funding for this research through the NIH must increase to ensure there isn’t a lag between research development and product development. The CBSA continues to advocate for increased funding of the NIH which will help advance biomedical innovation and ultimately improve patient care.

Members of the Colorado congressional delegation are becoming increasingly supportive of this effort. In late March 2015, a total of 169 House members, including four members of the Colorado congressional delegation – Jared Polis, Mike Coffman, Ed Perlmutter and Diana DeGette - signed on to support a bipartisan letter to House appropriators requesting at least $32 billion for the National Institutes of Health in Fiscal Year 2016. A similarletter in the Senate garnered support from 54 bipartisan cosigners, including both Colorado Senators Michael Bennet and Cory Gardner.

CBSA advocates that NIH (and its funding) is critical to ensure there isn’t a lag between research development, product development and is essential to ensuring that biomedical innovation advances and ultimately improves patient care.

 

Tax and Fiscal Policy

 

Medical Device Excise Tax: The Medical Device Excise Tax took effect in January, 2013, creating a new sales tax of 2.3% levied on medical devices regardless of company profit. In Colorado, the medical device industry is one of our fastest growing clusters, recognized as the 6th largest cluster in the nation with employment growth of 23% between 2007 and 2012. Repealing the Medical Device Excise Tax has been one of CBSA’s top priorities. The medical device excise tax puts jobs and innovative companies in our state at risk. The Colorado delegation has been supportive of this call to action with Senators’ Bennet and Gardner and Congressman Buck, Coffman, Lamborn and Tipton all helping lead the effort to repeal the tax. Through the continued education and advocacy on this issue, the Medical Device Excise Tax was included in the December 2015 Tax Extenders package and suspended for two years. CBSA will continue to advocate for the permeant repeal of the tax during the two-year moratorium and will urge members to support full repeal prior to its reenactment in 2018.

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Funding: Colorado consistently ranks in the top 10 for total number of grants awarded through the SBIR and STTR programs, receiving $316M in 2013 alone for research specific to the bioscience industry. As venture capital monies decreased through the recession and moved to support later stage technologies, these grants have help to spur new research and discovery at its earliest stages. However, this critical source of funding for promising new therapies and technologies has steadily declined in recent years. The lack of funding for the SBIR and STTR programs is a serious concern for CBSA and the bioscience community in Colorado. CBSA advocates for increased funding for the Small Business Administration to support the SBIR and STTR grant program to encourage the development of new medical innovations.

 

Medicare Coverage & Reimbursement

 

Medicare Part D: Medicare Part D, created through the Medicare Prescription Drug Improvement and Modernization Act of 2013, was established to provide affordable prescription drug insurance coverage. Part D is structured on a private-market, competitive bidding approach which encourages plan competition and increases the incentive to offer lower premiums. Over the past 10 years, Part D has consistently performed better than projected in the federal budget, costing the government 43% less than projected and saving beneficiaries about $1,200 a year. CBSA opposes proposals to enforce rebates and price controls on Medicare Part D, which would likely destabilize the program and decrease industry incentives to invest in new research and development.

Medicare Part B: Medicare Part B provides coverage for physician services and outpatient care. Reimbursement for medications under Medicare Part B relies on a market-based mechanism by calculating the Average Sales Price (ASP) plus 6%, which helps to cover both the overhead costs and the therapy. This method of payment has been successful in reducing Medicare costs since its inception in 2003; however, studies have found that physicians have difficulty obtaining products at or below the ASP+6% rate. Cuts instituted by the Budget Control Act of 2011 and put into effect by Sequestration, have decreased the Medicare reimbursement rates for Part B to ASP+4%, resulting in thin or non-existent margins for physicians and practices. CBSA opposes additional cuts and changes to reimbursement mechanisms within Medicare Part B, which could further constrain physicians and from being able to provide critical treatments to patients.

 

Intellectual Property and Patent Law

 

Patent Law: The America Invents Act (AIA), signed into law in September 2011, represents the most comprehensive changes to the U.S. patent system in more than 50 years. The law helped to establish four new satellite U.S. Patent and Trademark Offices (USPTO), including the site in Denver, to create a regional presence for USPTO and give inventors, entrepreneurs, and small businesses the added benefit of a USPTO presence in every time zone in the U.S. CBSA was pleased to see Denver selected as a satellite location. CBSA continues to monitor the implementation of the other initiatives within the AIA.

One issue Congress continues to consider is an effort to curb abusive litigation in the U.S. patent system. While reining in abuse of the patent system is important, equally important is maintaining the ability of legitimate patent holders to defend and enforce their intellectual property rights. CBSA has concerns with pending legislation, H.R. 9, Innovation Act, which would make it more difficult and expensive for patent holders to defend their rights in good faith. Two such proposals – mandatory fee-shifting and involuntary joinder – are especially troubling because they would make the legitimate defense of patent rights excessively risky and threaten to imperil venture capital funds essential to new and emerging technology companies. CBSA supported a national letter co-signed by more than 230 businesses and organizations urging leaders of the House and Senate Judiciary Committee to exercise caution before overhauling the nation’s patent laws. A similar letter, signed by 145 American universities and associated technology transfer foundations and organizations, reflected the same concerns. The CBSA also spearheaded aColorado specific letterto encourage Colorado's federal delegation to understand industry's concerns in regard to patent reform.

International: Intellectual property is the life-blood of the bioscience industry, making strong IP protections a critical priority for the industry both domestically and internationally. Strong IP rights found in current U.S. law, including but not limited to, twelve years of data protection for biologics, encourages progress, risk-taking, and efforts to deliver new treatments and new solutions to patients. Lack of enforceable incentives for innovation will undermine the common goal of providing new treatments for unmet medical needs around the world. CBSA will continue to monitor ongoing efforts to protect the rights of U.S. patent holders in future trade agreements, including the Trans-Pacific Partnership (TPP) and the Transatlantic Trade and Investment Partnership (TTIP).

 

Ag-Bio and Biofuels

 

Food and Product Labeling: CBSA promotes food and product labeling that is accurate, informative, not misleading, and communicates scientifically significant information relevant to health, safety and nutrition to consumers. CBSA is a member of the “Coalition for Safe and Affordable Food,” which supports H.R. 1599, Safe and Accurate Food Labeling Act which passed Congress in July 2017, helping to create a national labeling standard rather than a state-by-state patchwork.

Renewable Fuel Standard (RFS): CBSA 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. As the Environmental Protection Agency (EPA) finalizes proposed rules on biofuels volume requirements for 2014 and subsequent years under the RFS, CBSA hopes the EPA will issue a new proposal for 2014 and beyond that sets the RFS back on track and corrects the flawed methodology in the 2014 Renewable Fuel Standard (RFS) proposal. This effort has been supported by Colorado Senator Michael Bennet in 2014 and again in 2015.

 

Additional Initiatives

 

21st Century Cures: The CBSA commends and thanks the Colorado Congressional Delegation for their leadership and tireless commitment to passing the 21st Century Cures Act, the bipartisan package of innovative reforms that will help accelerate the discovery, development and delivery of medical advancements to ensure more timely access to new treatments and cures for patients in need throughout Colorado, nationally and abroad for years to come. We believe this is an important step to accelerate the discovery, development and delivery of cures for patients.

The $6.3 billion package includes money allocated towards new research funding for the National Institutes of Health and would overhaul the process the Food and Drug Administration uses to assess and approve new treatments. It establishes a framework for incorporating patient views; adds new device breakthrough pathway provision that will improve use of the FDA Expedited Access program; extends the Rare Pediatric Disease (RPD) Priority Review Program (PRV); provides a strategic focus on precision medicine through genomics and regulatory science; and takes first steps to allow for a broader range of healthcare economic information sharing with payers, which will facilitate the move towards a value based marketplace. The legislation also improves the selection of experts on FDA advisory panels; updates the Class I/II exemption list; allows for the use of central IRBs for device trials; requires FDA to update its CLIA-waiver guidance; reinforces FDA's use of the Least Burdensome principle in conducting reviews; clarifies FDA regulation of software and certain digital health technologies. As you know this all very positive for the Colorado bioscience community.

We believe the passage of 21st Century Cures Act represents a milestone accomplishment for medical innovation. We applaud the bipartisan Congressional support of the 21st Century Cures Act and thank them for working diligently to ensure the passage of the 21st Century Cures Act reached the finish line.

CBSA will continue to work to ensure that patients everywhere can benefit from the next generation of life-changing innovations.

Precision Medicine Initiative: Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. While significant advances in precision medicine have been made for select cancers, the practice is not currently in use for most diseases. Many efforts are underway to help make precision medicine the norm rather than the exception. To accelerate the pace, President Obama has unveiled the Precision Medicine Initiative. The near term goals for the Initiative are: to intensify efforts to apply precision medicine to cancer focusing on innovative clinical trial design; understand the benefits and potential of combination therapies; and, studying drug resistance. Long term goal is to create a research cohort of Americans who will share genetic data, biological samples, and diet/lifestyle information. The research cohort would have the potential to: advance pharmacogenomics; identify new targets for treatment and prevention; test whether mobile devices can encourage healthy behaviors; and, lay the scientific foundation for precision medicine for many diseases. The President’s Precision Medicine Initiative has been included in the provisions put forth by the 21st Century Cures Initiative, and CBSA will actively monitor both efforts.

Cancer Moonshot Task Force: Cancer is a leading cause of death, and cancer incidence is expected to increase worldwide in the coming decades. But today, cancer research is on the cusp of major breakthroughs. It is of critical national importance that we accelerate progress towards prevention, treatment, and a cure -- to double the rate of progress in the fight against cancer -- and put ourselves on a path to achieve in just 5 years research and treatment gains that otherwise might take a decade or more. CBSA will support the Moonshot Task Force as it is developed and promote the critical importance of cancer research.