Federal Policy – Advocacy

 

Federal Policy Advocacy 

Federal Policy Priorities:

A key value we bring our members is to advocate on behalf of this industry. Last fall we released our Bioscience Economic Development Report that demonstrated this industry contributed $27b in economic output to the state, and $716 million in total state and local taxes. The biohealth industry, excluding our research universities and healthcare system organizations, directly employs 36,000 workers and indirectly 70,000 additional jobs. The industry multiplier effect is only behind energy on the jobs impact to the state. This report can be found here. 

US_Capitol_west_sideDuring the last eight months, BioForward, along with its coalition partners under Cures For Tomorrow successfully protected research in Wisconsin by actively opposing AB 305/ SB 260. We have been cited by the Biotechnology Innovation Organization (BIO) and other organizations for our successful defense against these bills that could have halted critical advances in biomedical innovation and hampered the growth of our thriving industry.

BioForward has worked closely with Biotechnology Industry Organization (BIO), Pharmaceutical Research and Manufacturers of American (PhRMA) and the Advanced Medical Technology Association (AdvaMed) to advocate for mutual legislative goals and to ensure that Wisconsin companies' voices are heard by federal elected officials.

2016 Federal Policy Priorities:

National Institutes of Health:

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. This public investment has laid the foundation for the development of many breakthrough drugs and therapies that have extended and improved the lives of countless patients and their families in the United States. The NIH also serves to drive the innovation pipeline that is critical to ensuring that the medical research and biopharmaceutical industry, which provides high-paying jobs and makes significant contributions to the U.S. economy, continues to grow in the United States 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. BioForward continues to advocate for increased funding of the NIH, which will help advance biomedical innovation and ultimately improve patient care.

Members of the Wisconsin congressional delegation are becoming increasingly supportive of this effort. In late March 2015, a total of 169 House members, including 2 members of the Wisconsin congressional delegation – Mark Pocan and Gwen Moore - 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 similar letter in the Senate garnered support from 54 bipartisan cosigners, including Wisconsin Senator Tammy Baldwin

This effort was successful, within the Fiscal Year 2016 Omnibus Appropriations Act the NIH will receive $32.1 billion, a $2 billion increase over the 2015 enacted level. Additionally, H.R. 6, the 21st Century Cures Act, would provide additional mandatory funding to support the work of the NIH. BioForward supports H.R. 6 and its anticipated Senate counterpart “Innovation for Healthier Americans.” We will continue to work with our delegation to support the work of these two legislative initiatives and advocate for increased funding to the NIH.

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. Repealing the Medical Device Excise Tax has been one of BioForward’s top priorities, which is putting jobs and innovative companies in our state at risk. The Wisconsin delegation has been supportive of this call to action with Senator Ron Johnson and Congressmen Paul Ryan, Sean Duffy, Jim Sensenbrenner, Reid Ribble, and Glenn Grothman 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. BioForward will continue to advocate for the permanent repeal of the tax during the two year moratorium and will urge members to support full repeal prior to its reenactment in 2018. Medical technology creates more than two million jobs directly and indirectly all over the United States. The industry is one of the few U.S. manufacturing sectors that is a net exporter, and its innovations help reduce the human and economic burden of chronic disease, but the device tax threatens that leadership because it will put an additional burden on medical device innovators already struggling under the weight of America’s uncompetitive tax system. The tax will be levied on medical device sales in the U.S. regardless of whether the company is making a profit.

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Funding: 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 BioForward and the bioscience community in Wisconsin. BioForward 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.

In addition to the NIH’s role of supporting medical research, it also provides critical early-stage funding opportunities to small U.S. biotechnology companies developing innovative medicines through the Small Business Innovation Research and Small Business Technology Transfer programs. NIH’s Cures Acceleration Network also offers collaboration and funding opportunities for public-private partnerships to advance the development of high-need cures and reduce significant barriers between research and clinical trials. The National Center for Advancing Translational Sciences is doing important work to facilitate medical innovation and enable partnerships between government and industry to transform the translational science process in order to better enable industry to develop and deliver treatments and cures to patients faster. Wisconsin is home to two Centers for Translational Sciences, UW-Madison and Medical College of Wisconsin. Our state also has an outstanding support network for SBIR/STTR grants through The Center for Technology Commercialization. See our resources available to BioForward members under the Resource section of our website.

Medicare Coverage and 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, total Part D costs are $349 billion (or 45 percent) less than initial 2004-2013 projections, according to the Congressional Budget Office. And average monthly premiums for 2015 are about $32, roughly half the original estimates. BioForward 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 is the government program that insures many of the nation’s retirees and individuals with disabilities. Part D provides comprehensive, affordable access to medicines, and helps keep seniors healthier. Outpatient prescription medicines are generally covered by Medicare Part D, which began providing prescription drug benefits in 2006.

Medicare Part B: Medicare Part B provides coverage for physician services and outpatient care. Injected or infused vaccines and medicines administered or purchased by physicians are generally covered by Medicare Part B, which equates to the medical benefit provided by commercial insurance plans. 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. BioForward 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.

Additional Initiatives:

The President’s Precision Medicine Initiative Cohort, the Vice President’s National Cancer Moonshoot initiative and the White House Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative all have the potential to advance biomedical science and potentially improve the drug development process, thus improving the ability of the biopharmaceutical industry to develop and provide modern medicines to the patients who need them.

21st Century Cures: Entrepreneurial biotechnology companies are at the cutting edge of a new and revolutionary understanding of the genetic and biomolecular underpinnings of disease, and are committed to developing the next generation of medicines to transform patient care. However, this goal can only be realized in a public policy environment that sustains scientific discovery and biomedical innovation. BioForward commends the House Energy & Commerce Committee, and Wisconsin Congressmen Gwen Moore, Mark Pocan, and Ron Kind, for their work on H.R. 6, the 21st Century Cures Act. We believe this is an important step to accelerate the discovery, development and delivery of cures for patients. BioForward will continue to monitor the progress of H.R. 6 and companion legislation in the Senate. The medical technology industry is central to the development of medical devices and diagnostics that will provide the life-saving and life-enhancing treatments of the future. But the innovation ecosystem that supports our industry is severely stressed. Policy improvements are essential if America is to retain its world leadership and the advance medical progress in this century of the life sciences. The opportunity for better treatments and cures is immense, but patients will only reap the benefits if the ecosystem is strengthened. Failure to act will mean lost lives, unnecessary suffering, reduced job formation, and diminished economic growth. Collaboration among patients, physicians, medical technology companies and other stakeholders is crucial to generating the evidence necessary to support the next generation of medical innovations.

Work on a Senate package of bills similar to the House’s 21st Century Cures Act was sidetracked this summer by the challenge of how to fund the bill. Passed by the House in July 2015, the Cures Act seeks to modernize the Food and Drug Administration (FDA) and the National Institute for Health (NIH). The Senate has proceeded at a slower pace, and in July Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) announced that the Senate package would not receive floor action until after the summer recess at the earliest. Before members left for the recess, Energy & Commerce Committee Chairman Fred Upton (R-MI) announced that he has identified new ways to pay for the effort, which puts the legislation on a very short list of items that could actually pass in September or a lame duck.

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 BioForward 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. BioForward will support the Moonshot Task Force as it is developed and promote the critical importance of cancer research.

In June, Vice President Biden convened a summit to garner support for the President’s year-long initiative to advance cancer research. The summit hosted three hundred people from academia, the health industry, and advocacy organizations. Topics ranged from easing access to clinical trials to data sharing

Microbiome Initiative: Microbiomes are the communities of microorganisms that live on or in people, plants, soil, oceans, lakes, rocks, and the atmosphere. These microbial communities help define the health and integrity of their living or inanimate hosts. Microbiomes influence the behavior of diverse ecosystems, with effects on human health, climate change, food security, and other factors. The National Microbiome Initiative (NMI) will focus on comparative study of microbiomes across different ecosystems to seek organizing principles that shape all microbiomes. Understanding these principles are necessary to develop approaches to reliably alter microbiomes to benefit individuals, communities, and societies. BioForward will support the National Microbiome Initiative as it is developed and promote the critical importance of microbiome research.

Patent Reform: Intellectual property is the lifeblood of the biotechnology industry. Strong patents, and an efficient, predictable, and objective patent system, are critical to ensuring a steady stream of capital to biotechnology companies developing innovative medicines, alternative energy sources, insect- and drought-resistant crops, and a wide range of other innovative biotechnologies that are helping to feed, fuel, and heal our planet. 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. One issue Congress continues to consider is an effort to curb abusive litigation in the U.S. patent system. Despite their well-intentioned efforts to curb abuses, proponents of patent litigation reform are pressing for sweeping ideas to remake the patent litigation system in fundamental and untested ways, based on questionable data and without sufficient consideration of the impact of those changes on the vast majority of patent owners and licensees who engage in legitimate and good faith patent licensing, partnering, and enforcement activities. 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. BioForward 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.

Opioid Legislation: Congress recently approved legislation to combat the ongoing opioid abuse epidemic. The House passed the Comprehensive Addiction and Recovery Act (CARA) conference report by an overwhelming vote of 407-5. The Senate later approved the measure by vote of 92-2. Democrats had threatened to block the measure if Republicans did not agree to provide additional funding for abuse and treatment programs. They relented after the White House refrained from issuing a veto threat. While CARA does not include new resources, it is broadly supported by a wide range of health groups because it fundamentally reforms and restructures grant funding for substance abuse. The legislation now goes to the President for his signature.