Federal Policy Priorities

2018 Federal Policy Priorities: 

Food and Drug Administration (FDA)

Colorado continually ranks in the top ten states for bioscience. The state is currently home to a thriving industry, comprised of more than 725 biotechnology, medical device, diagnostic, digital health, pharmaceutical, health care providers, research institutions and those businesses that provide critical services and products to bioscience companies. The industry employs over 30,000 individuals creating over 159,000 direct and indirect jobs, translating into over $2.8 billion in annual payroll.

The CBSA team leads advocacy efforts on behalf of the industry and our members. We work every day to create an innovation-friendly business environment. Our policy activities at the state and federal level focus on proactive and reactive legislation. Our commitment to strong connections with federal, state and local officials fosters a culture that promotes bioscience breakthroughs.

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 and to ensure that Colorado companies’ voices are heard by federal elected officials.

The following issues have been identified by CBSA and the Public Affairs & Government Relations Committee as priorities for action in 2018.

Regulatory Environment - FDA

The drug and device review and approval process, communication between industry and FDA, and transparency and accountability within the agency are vital to CBSA and the bioscience industry in Colorado. CBSA monitors and engages on important regulatory matters on behalf of the Colorado bioscience industry. CBSA supports policies that promote bioscience innovation by enhancing industry-FDA communications, regulatory process, strengthening FDA performance reporting requirements, and improving product review process predictability, consistency and transparency.

Funding and User Fees: A well-funded, science-based FDA and consistent, predictable and transparent product review processes are critical to and necessary for biomedical investment, innovation and improvements in patient care. 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.

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. CBSA will continue to focus efforts on ensuring appropriate and transparent implementation of the regulatory pathway for the approval of biosimilar products.

21st Century Cures: In December 2016 the 21st Century Cures Act, was signed into law. This 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.

The $6.3 billion package included money allocated towards new research funding for the National Institutes of Health with dedicated funding for major initiatives including the Precision Medicine Initiative, BRAIN Initiative, and Cancer Moonshot.

It builds on FDA's ongoing work to incorporate the perspectives of patients, enhances FDA’s ability to modernize clinical trial designs and clinical outcome assessments, provides new authority to help FDA improve the ability to recruit and retain scientific, technical, and professional experts and establishes new expedited product development programs, including:

  • The Regenerative Medicine Advanced Therapy, or RMAT
  • The Breakthrough Devices program, designed to speed the review of certain innovative medical devices.

Research and Funding

Federal investment in research is essential to the development of new drugs, vaccines, and technologies by supporting breakthrough research. Colorado is one of the nation's top bioscience industry clusters, which is a direct result of the research and education being conducted within the state’s academic institutions. Our research institutions are leaders in innovation and new company creation. With 20+ new bioscience start-ups forming each year from university research and continual basic research leading to new discoveries, supporting higher education, and promoting university research and technology transfer activities is a top priority for the Colorado BioScience Association.

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.

In fiscal year 2016 Colorado received $350 million in NIH funding, with 39 NIH-funded institutions, 991 NIH grants awarded, and the initiation of 55 NIH clinical trials. CBSA advocates that NIH is critical to support and ensure that biomedical innovation advances. We applaud the CO Delegation for their leadership in advocating for increased NIH funding for the nation and State of Colorado.

Protect Innovation, Tax, Fiscal, and IP Policy

Tax, IP and trade policies can influence life sciences investment, innovation and job creation and enhance competitiveness. CBSA advocates for a tax and regulatory environment that encourages business development.

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. Repealing the Medical Device Excise Tax has been one of CBSA’s top priorities. The nine-county Metro Denver and Northern Colorado region ranked 11th out of the 50 largest metro areas for medical devices and diagnostics employment concentration in 2016. With direct employment in the medical devices and diagnostics sub cluster of about 11,160 employees, the region ranked eighth. Nearly 82 percent of Colorado’s medical devices and diagnostics employees work in the nine-county region. The excise tax puts jobs and innovative companies in our state at risk. We continue to express to the delegation the adverse impact on R&D investment and job creation by the tax thereby jeopardizing the U.S. position as a global leader in medical device innovation. 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.

Tax Reform

Tax reform has the opportunity improve U.S. competitiveness, create new jobs, and boost the U.S. biopharmaceutical industry with the development of lifesaving treatments and cures. We advocate to maintain the Orphan Drug Tax Credit and the R&D tax credit, repeal the medical device excise tax and for the inclusion of incentives for pre-revenue innovation. CBSA will monitor tax reform as it progresses ensuring the bioscience industry remains a global leader in innovation.

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 in Denver. CBSA support efforts to bring an end to abusive patent litigation but urges Congress (when looking at policy solutions) to craft a narrowly drawn approach that targets the practices of those parties abusing the system while maintaining the right of legitimate patent holders to assert their intellectual property rights in court. Without a strong and robust system, businesses and universities would be increasingly prevented from capitalizing on their research, stunting the innovation cycle, and the accompanying economic growth, enabled by a balanced patent system. We advocate for Congress to maintain this crucial balance in any future legislation.

Intellectual Property

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.

Federal Healthcare

Medicare Part D:Medicare Part D,created through the Medicare Prescription Drug Improvement and Modernization Act was established to provide seniors and individuals living with disabilities with access to affordable prescription drug coverage. Part D is structured on a private-market, competitive bidding approach which encourages plan competition and increases the incentive to offer lower premiums. Part D has consistently performed better than projected in the federal budget, costing the government 45% 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 office visits, outpatient care, ambulance services, some medical devices and medicines administered by a physician. Medicines covered by Part B include treatments for complex conditions like cancer, rheumatoid arthritis, autoimmune conditions and more. Reimbursement for medications under Medicare Part B relies on a market-based mechanism by calculating the Average Sales Price (ASP) plus 6%, 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.

Independent Payment Advisory Board

The Independent Payment Advisory Board, created as part of the Affordable Care Act, is a 15-member board appointed by the president and approved by the Senate that is charged with proposing cuts to Medicare spending if that spending exceeds a certain growth target. In recent years, bipartisan efforts have called for repeal of IPAB due to its impact on patient care, mandatory cuts to Medicare and the board make up. CBSA supports the repeal of IPAB and encourages the Colorado Delegation to work together to repeal IPAB.

Importation: U.S. Food and Drug Administration’s (FDA) comprehensive drug approval process and medicines on the U.S. market are regarded as the safest in the world. The FDA regulates virtually every stage of a prescription drug as it moves through the U.S. supply chain. Legalizing the importation of unapproved medicines would open the U.S. prescription drug supply to unapproved foreign drugs, creating multiple avenues for unscrupulous counterfeiters to enter the U.S. market, threatening patient safety. For these reasons CBSA opposes importation.

Ag-Bio

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 supported the passage of H.R. 1599, Safe and Accurate Food Labeling Act, helping to create a national labeling standard rather than a state-by-state patchwork.

Digital Health

Digital health, life science innovators and entrepreneurs are bringing new and innovative ways to care for patients, improve the health populations, and influence the way medications are prescribed and developed. The broad scope of digital health includes categories such as mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Providers and other stakeholders are using digital health in their efforts to: reduce inefficiencies, improve access, reduce costs, increase quality, and, make medicine more personalized for patients. Patients and consumers can use digital health to better manage and track their health and wellness related activities.

CBSA will monitor work both occurring at the FDA and in Congress ensuring that aspects of the bioscience industry are protected and patients see an increased access to life saving technologies.

 

 

 

1 The nine-county region is comprised of two principal areas, Metro Denver and Northern Colorado. Metro Denver consists of Adams, Arapahoe, Boulder, Broomfield, Denver, Douglas, and Jefferson counties. Northern Colorado consists of Larimer and Weld counties. http://www.metrodenver.org/d/m/3T3

 

2 Employment concentration is the direct cluster employment in a region expressed as a percent of total employment in all industries in the same region. Employment concentration is calculated and ranked for the 50 largest metropolitan statistical areas (MSAs). Direct employment is the number of employees in the industry cluster in a region. No multiplier effects are included. Direct employment is estimated and ranked for the 50 largest MSAs. http://www.metrodenver.org/d/m/3T3