Advocacy Updates

Legislative Advocacy Updates:

Through both legislative and communication efforts, BioForward promotes the activities of Wisconsin’s biohealth companies. To get legislative advocacy updates to your email inbox, click here to sign up for our newsletter. 

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March 2018 Advocacy Updates:

 

Wisconsin Passes Biosimilars Bill to Cut Costs for Patients and Boost Wisconsin’s Biohealth Industry – March 28,2018

With bi-partisan support, BioForward applauds the passage of the biosimilars authorizing legislation (AB679 /  SB575 ). This bill will allow pharmacists to dispense biosimilars, unless the prescribing authority specifically prohibits substitutions, savings patients money through cheaper equivalents.

Biosimilars are biological products are therapeutically equivalent to or otherwise interchangeable with other biological products, approved and regulated by the FDA. Under previous Wisconsin law, pharmacists could not dispense cheaper biosimilars in place of prescribed biological products.  This legislation also includes labeling and reporting requirements for biological products.

BioForward and their legislative council, Jordan Lamb of DeWitt Ross and Stevens, has worked persistently over the past year for the passage of this bill that will reduce costs of patients while also boosting the prosperity of Wisconsin biohealth companies that produce these cost-friendly alternatives.

 

State Advocacy Update

  • Pursued Policies that Support Economic Development in the Biohealth Sector. Support for innovation through economic development initiatives is an important issue for BioForward. Accordingly, BioForward collaborated with The Water Council to design legislation with Senator Alberta Darling and Representative Adam Neylon to foster investment into specific industry cluster economic development programs such as challenge grants, R&D funding and increased investment into Wisconsin’s successful SBIR matching grant program-SBIR Advance. This legislation, (SB525/AB640) The Wisconsin Workforce and Innovation Network for Success (WINS) Act, successfully passed through standing committees with bi-partisan support, but failed to get approval by the full legislature this session. Throughout 2018 and 2019 we will continue to promote this legislation for passage in 2019-2020 budget session.
  • Strengthen Healthcare Initiatives for Wisconsin Citizens. BioForward worked with BIO and a nationwide coalition of stakeholders to seek adoption of biosimilars authorizing legislation (AB679/SB575) in Wisconsin. This legislation was authored by a very strong group of bi-partisan legislators including: Reps Deb Kolste(D), Mike Rohrkaste(R), John Spiros (R) and Sens. Tim Carpenter(D) and Leah Vukmir(R). This legislation has passed both the Assembly and Senate is now awaiting Governor Walker’s signature.
  • Support for UW-Madison and the University of Wisconsin System. A strong and vibrant university education and research community is an essential part of a strong and vibrant biohealth economy. Hence, BioForward’s advocacy program continually supports a well-funded UW-Madison and UW System budget. We worked alongside the university during the 2015-17 state biennial budget process. Additionally:
    • BioForward continuously works with our Cures For Tomorrow Coalition partners to prevent the adoption of legislation
      in Wisconsin that would ban specific types of research in the State. To date, no legislation has advanced in Wisconsin.
  • Support Legislation to Promote Research, Jobs and Entrepreneurs. This session, BioForward also supported the UW in seeking an amendment to Wisconsin’s restrictive self-dealing law that includes an overly cumbersome and lengthy process for allowing research companies to contract with the university when a faculty or staff member has an interest in the company. Even relatively small contracts (any contract exceeding $250,000 over a two-year period) tied to relationships that have been reviewed previously by the university must receive a 45-day review by the UW Board of Regents. AB 758 / SB 671 authored by Rep. Dave Murphy and Senator Dan Feyen, along with Senators Risser and Rep. Berceau, will create a more workable system within the UW for development of management plans that will identify and manage any potential conflicts of interest. This legislation has passed the Assembly and awaits consideration by the State Senate in March.

National Advocacy Update

  • Federal Budget Bill Passage to Suspend Medical Device Tax. Although the medical device tax, an excise tax on medical device sales, was not repealed, BioForward and partners across the nation were satisfied with the continuation of suspending this burdensome tax. Wisconsin is a leading medical device manufacturing state and if this tax had not been suspended, companies from early stage to our large medical device companies, like GE Healthcare, would have begun paying excise taxes in January 2018, reducing their ability to reinvest in further product development and expansions.
  • Tax Reform Act. BioForward took no position on this federal legislation. Similarly, BIO and AdvaMed remained neutral on this federal budget bill.
  • Broad Range of Issues to Protect and Support BioForward Members
    o IPAB Repeal
    o Maintaining Orphan Drug Tax Credits
    o Clarifying CMS Language on Biosimilars
    o Signed onto Support for PDUFA and MDUFA Legislation and Letter to Secretary Price
    Relaying Concerns to Changes to Medicare Part B
    o Ensuring Patient Access to Critical Breakthrough Products Act of 2018
  • BIO Fly-In. BioForward participated with BIO and other state associations for a legislative day April 2017, Washington D.C. We met with Wisconsin congressional offices focusing on biohealth issues such as NIH and FDA funding support, protecting Medicare Part B & D, medical device tax, and open discussions on drug pricing.

December 2017 Advocacy Updates:

National Advocacy Update

Medical Device Tax: 

BioForward supports the repeal of the medical device tax or at minimum, supporting the introduction of a 5-year suspension of the medical device tax. We continue to work with our partners, Advamed and MDMA, to advance this federal legislation.

State Advocacy Update

Workforce and Innovation Network for Success (WINS) Act:

BioForward supports the Wisconsin Workforce and Innovation Network for Success (WINS) Act (2017 SB 525 / 2017 AB 640), authored by Senator Alberta Darling, Senator Dan Feyen, Senator Van Wanggaard and Representative Adam Neylon.

This groundbreaking economic development legislation would create an Innovation Fund and Council charged with identifying opportunities for more private sector engagement and national and international exposure for industry clusters in Wisconsin.  This legislation would support the cluster-based model of economic development that is working today in Wisconsin’s biohealth sector.

Funding that is generated by the Innovation Fund will be used to further enhance strengths in Wisconsin’s economy such as biohealth, water technology, food and beverage industries, energy and advanced manufacturing through four main channels:

  • Challenge grants that will incite innovative product development through competition
  • Key partnerships that build industry cluster capacity
  • Early stage R&D grants that push new products to prototyping and field testing
  • Small Business Innovation Research (SBIR) matching grants to launch technologies to commercialization

Biosimilars Legislation Updates – AB679 /  SB575 

BioForward has been working with BIO and a nationwide coalition of stakeholders to seek the adoption of biosimilars authorizing legislation in Wisconsin during the fall 2017 session. This legislation has been adopted in 36 states to date.

The legislation was authored by a very strong group of bi-partisan legislators: Reps. Mike Rohrkaste (R), John Spiros (R), and Deb Kolste (D); and Sens. Leah Vukmir (R) and Tim Carpenter (D).

BioForward took part in the following hearings:

  • Senate Health Committee Hearing – December 12, 2017
  • Assembly Health Committee Hearing – December 13, 2017

Protecting Research in Wisconsin: 

BioForward continuously works with our Cures for Tomorrow Coalition partners to prevent the adoption of legislation in Wisconsin that would ban specific types of research in the State.  Currently, no legislation is advancing, but we still expect additional pressure on this issue during the last days of this legislative session.  Right to Life groups are putting increasing pressure on candidates to take “prolife votes.”

  •  Senate Bill 422 / AB 83 (Darling/Duchow) – This legislation ALLOWS fetal tissue research to continue in Wisconsin, but establishes in statute the most stringent ethical standards for this type of research enacted by any state.  (The ethical standards are taken from federal NIH guidance and IRB practices.)  Bioforward is neutral on this legislation.  Senate Judiciary Committee hearing was held on this bill on November 2, 2017.
  • Senate Bill 423 / AB 549 (Mouton/Kleefisch) – This legislation would BAN the used of fetal tissue and cells from being able to be used in research in the State of Wisconsin.  BioForward opposes this legislation.  (See attached written statement.) Senate Judiciary Committee hearing was held on this bill on November 2, 2017.

Assembly Science and Technology Committee Informational Hearing on Biomanufacturing: 

BioForward worked with Representative David Steffen and Representative Romaine Quinn to schedule an informational hearing before the Assembly Science and Technology Committee to brief the committee and the public about the emerging biomanufacturing sector in Wisconsin.

The hearing was well-attended and consisted of the following invited speakers: Dr. Bill Murphy, UW-Madison; Lisa Johnson, CEO, BioForward; Dr. David Gamm, Co-Founder and Chief Scientific Officer, Opsis; Joanne Payne, VP of Human Resources, Phillips-Medisize; Todd Asmuth, SHINE Medical Technologies; Erika Long, Senior Director Government Affairs, Mallinckrodt-Stratatech.

This was the first opportunity that BioForward had this session to talk to legislators directly about our industry, what changes are happening and what resources we need to continue to grow. It was critical to set the stage for the WINS Act legislation, which was release just a couple of weeks following this hearing.

August 2017 Advocacy Updates:

National Advocacy Update

Medical Device User Fee Amendments (MDUFA): 

The Senate approved H.R. 2430, the FDA Reauthorization Act of 2017, as passed by the House.  The measure was passed by a vote of 94 to 1. The bill will now be sent to the President who is expected to sign it.  This important package includes several key positive provisions for the medtech industry. https://www.advamed.org/newsroom/press-releases/advamed-applauds-senate-vote-mdufa-reauthorization

Food and Drug Reauthorization Act (FDARA) & Prescription Drug User Fee Program (PDUFA):

On August 3rd, the Senate passed the Food and Drug Reauthorization Act (FDARA), which includes the Prescription Drug User Fee Program. Next, it will go to the President to be signed into law. The user fee program reauthorization package passed by the Senate today is an important victory for patients and for the next generation of medical innovation. This legislation will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. It also ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development. http://action.bio.org/f0pQtVh

Medicare Part B:

Signed onto a letter to Secretary Price to protect Medicare Part B for reimbursing providers for drugs and biologics administered by physicians.

Drug Pricing:

Drug pricing continues to be a topic of discussion and debate. BIO has developed a web site to provide more transparency to this issue through the following web site: http://www.drugcostfacts.org/

State Advocacy Update

Foxconn Investment in Wisconsin:

After a recent announcement of Foxconn Technology Group investing in a high-tech manufacturing plant in Southeast Wisconsin, a public hearing was held on August 3rd at the Wisconsin State Capital.

Lisa Johnson, CEO of BioForward, spoke on behalf of Foxconn promoting the opportunities it can provide to the biohealth industry in Wisconsin.

Interested in More Legislative Insight?

Hear from national and local government relations leaders on the status of healthcare and biohealth legislation at the Wisconsin Biohealth Summit panel: Looking Forward: The Impact of Future Healthcare Reform on the Biohealth Industry. Learn more and register today: https://www.bioforward.org/wisconsin-biohealth-summit/

April 2017 Advocacy Updates

State Advocacy Update

  • BioForward and Cures for Tomorrow Work to Preserve Research in Wisconsin

BioForward is a member of the Cures for Tomorrow Coalition – a coalition of Wisconsin academic research institutions, bioscience-related trade groups and health care providers. The coalition supports and advocates for biomedical research in Wisconsin and is committed to educating the public about the value of biomedical research to patients and the state.  Members of the Coalition include BioForward, the Medical College of Wisconsin, UW Health, the University of Wisconsin-Madison and the Wisconsin Alumni Research Foundation.

Cures for Tomorrow engages with the Wisconsin legislature on any legislation that could impact or restrict the research that is permitted to be conducted in the State of Wisconsin.  Legislation that would ban the use of fetal cells in research in Wisconsin has been drafted and has circulated for co-sponsorship, but as of the time of this writing, it had not yet been introduced.

Research using fetal cells and tissue is already heavily regulated by federal law and the policies of our member research institutions. Profiting from the sale of fetal tissue, for example, has been a federal crime for more than two decades. Cures for Tomorrow members strongly oppose profiting from the sale of fetal tissue but do not believe that any additional regulation by the State of Wisconsin is needed.

BioFoward and Cures for Tomorrow works to educate the members of the Wisconsin State Legislature and others about the life-saving research that is being done in the State of Wisconsin.  For more information about Cures for Tomorrow, go to www.curesfortomorrow.org.

  • JFC Begins 2017-19 Biennial Budget Bill Review

Governor Scott Walker’s proposed biennial budget has been introduced and is in the process of being review by the State Legislature.  The Joint Committee on Finance has completed its state agency briefings on the Governor’s 2017-19 biennial budget bill and held public hearings across the state on the Governor’s proposed state budget.

The Committee will start voting on the budget provisions the first week in May and will continue through the early part of June.  The goal is complete the budget process before the end of the fiscal year, which is June 30, 2017.

Federal Advocacy Update

  • Supported passage of the 21st Century Cures Act that contained funding for the NIH and Next Generation Researchers. Passed in both the House and Senate January 2017
    • BioForward held meetings during the BIO Fly-In with federal legislators reinforcing our research institutions and industry’s dependence upon full appropriations to NIH, BARDA, and Project BioShield. President Trump had recommended a $6b decrease in NIH funding
    • NIH spurs key basic discovery in an era of genomic health and personalized medicine. BioForward supports increased resources for NIH and opposes cuts to its budget
  • Supported Representative Ron Kind’s sponsorship of the Protect Medical Innovation Act of 2017 that would repeal the Medical Device Excise Tax.

        Op-ed written by Advamed and BioForward on the repeal of the Medical Device Excise Tax.

  • Supporting passage of negotiated FDA User Fee Agreements-Medical Devices and Prescription Drugs (MDUFA and PDUFA)

. Passage of these fee agreements will provide the FDA with the resources needed to advance modern, patient-focused drug development and medical device approaches

  • Oppose changes to the Medicare Part B Drug Program.

Medicare Part B coverage and payment supports access to critical medicines and specialist physicians relied on by the most vulnerable and sickest patients

  • Oppose changes to Medicare Part D Drug Program.

Medicare Part D ensures that seniors have access to a broad choice of retail drugs and its structure keeps overall costs to beneficiaries and the government down. 90% of beneficiaries are satisfied with the program

  • BIO Fly-In.

BioForward participated with BIO and other state associations for a legislative day April 2017, Washington D.C. We met with Wisconsin congressional offices focusing on biohealth issues such as NIH and FDA funding support, protecting Medicare Part D, medical device tax, targeting abuses of U.S. patent system, and support to the Fostering Innovation Act.

2016 Legislative Advocacy Updates:

 

December 7th: Senate and House Pass 21st Century Cures Act 

The Senate passed the 21st Century Cures act on Wednesday, sending it to the desk of President Barack Obama, who says he will sign it. The $6.3 billion legislation easily passed the Senate in a vote of 94-5 and the House in a vote of 392-26.

BioForward is very proud to have been an engaged advocate for the Act, working closely with BIO, AdvaMed, and PhRMA to ensure biohealth advances continue.

Click Here to read the full update:

November 16th: Wisconsin State and Federal Races Post-Election Update

The November 8, 2016 election saw Republicans increase their majorities in both houses of the Wisconsin State Legislature.

Republicans in the Wisconsin State Assembly and Senate have selected their leadership for the new legislative session that begins January 3rd. Also at the federal level Wisconsin became a “red” state at the top of the ticket for the first time since 1984 with a win for Donald Trump.

Click Here to read the full update including info on:

June 2016

May 2016

  • S.1890 Defend Trade Secrets Act of 2016 was signed into law by President Obama on May 11, 2016.  Read more..https://www.baldwin.senate.gov/press-releases/defend-trade-secrets-act-passes
  • Fostering Innovation Act: The JOBS Act provides emerging growth companies (EGCs) with a five-year exemption from Section 404(b) of Sarbanes-Oxley (SOX), which requires a costly external attestation of a company’s internal financial controls. The Fostering Innovation Act would extend the JOBS Act’s SOX 404(b) exemption for an additional five years for former EGCs that maintain a public float below $700 million and average annual revenues below $50 million. The additional five years of cost-savings would allow growing companies to focus their capital on groundbreaking R&D rather than one-size-fits-all regulatory burdens. Read more here: https://www.bio.org/press-release/bio-applauds-house-passage-fostering-innovation-act 

April 2016 

  • Support full appropriations for NIH, BioShield SRF & CARB Initiative. NIH spurs key discovery in an era of genomic health and personalized medicine. We support a budget of at least $34.5b and oppose additional cuts. Full appropriations are needed to BARDA, Project BioShield and CARB Initiative to spur discovery and development of products designed to battle emerging security threats. We praise the House of Representative’s passage of the 21st Century Cures Act read more.. http://www.phrma.org/media-releases/phrma-statement-on-house-passage-of-21st-century-cures-act 
  • Target Abuses of the US Patent System While Protecting Innovation. BioForward supports a measured, thoughtful approach to patent litigation reform. Halt abuses of the IPR process, an administrative patent challenge, is a top priority but strong intellectual property protection is the lifeblood of the biotech industry. Strong patent protection is critical. We urge Congress to proceed thoughtfully and deliberately on patent reform litigation
  • Opposed CMS’s recently proposed Part B Drug Payment Model which threatens patient access to needed therapies; especially in rural areas and/or by community-based providers by slashing reimbursement rates to effectively ASP+0%. Read BIO’s position pape: https://www.bio.org/sites/default/files/BIO_Comments_Part_B_Proposed_Rule_May92016.pdf
  • Breakway Pathway Legislation Introduced. This bi-partisan legislation streamlines CMS’s coverage and reimbursement process for innovative medical technologies. Read more.. http://advamed.org/news/209/advamed-commends-house-legislation-to-streamline-cmss-process-for-breakthrough-technologies

March 2016 

https://pocan.house.gov/media-center/press-releases/pocan-introduces-next-generation-researchers-act

January 2016 Update on AB 305 / SB 260

  • BioForward and our member companies support and value the ongoing development of lifesaving research at UW-Madison, the Medical College of Wisconsin, and other institutions across our state. Our companies are the link between academic research and the therapies that are available to patients and families struggling with health issues or injuries. Accordingly, we are working with our colleagues from these research institutions and the Wisconsin Legislature to protect research in Wisconsin that utilizes fetal tissue.Under currently proposed legislation, in the State of Wisconsin, it would be a felony to use ANY fetal cells, fetal cell lines, or fetal tissues for research under all circumstances if those cells were obtained after January 1, 2015.The sale of fetal tissue is already illegal under federal law. We strongly support that prohibition and our research institutions abide by that prohibition. The bills currently being considered, AB 305/SB 260, go much further. If this legislation passes, we are closing the door on any future research that would be used to develop vaccines, therapies, and other medical innovations.For more information about this legislation and the Cures for Tomorrow coalition fighting to preserve research in Wisconsin, go to www.curesfortomorrow.org.

July 2015

BIOFORWARD FEDERAL CALL TO ACTION: Protect Innovation – Repeal the Medical Device Excise Tax

September 2015

BioForward Response to AB 305
BIO Response to Wisconsin Assembly Bill 305
Launch of Wisconsin Economic Development Report

December 2015

Support swells for vital university research using fetal tissue and cells

AdvaMed, MITA & MDMA Applaud Congress for Passage of the Medical Device Tax Suspension