Advocacy
Wisconsin’s independent voice- advocating to strengthen Wisconsin’s biohealth industry.
Public Policy Plays a Critical Role in Biohealth Industry Success
“BioForward Wisconsin’s mission is a leading force in our advocacy efforts. As an organization, we believe that improving and saving lives is neither a partisan nor a local issue. We work within the entire political spectrum to serve the industry, champion parties and policies that support patients and technologies that save lives, and advocate for the best outcomes for patients. As an action-oriented association in the heart of the biohealth innovation territory, BioForward is uniquely positioned within an interconnected ecosystem of biohealth organizations at the frontier of life sciences and medical breakthroughs to advocate regionally and nationally to impact health on a global scale. ”
-Lisa Johnson, CEO
BioForward works actively to:
- Shape state and federal policy through education and engaging with policymakers
- Collaborate with legislators, industry, and research institutions on critical biohealth issues and initiatives
- Monitor and inform members of legislation that will impact our industry
- Educate members on how they can be engaged in public policy
- Provide essential data to decision-makers on the economic benefit of Wisconsin’s biohealth industry
Support Public Funding for the Universities of Wisconsin
Wisconsin’s biohealth industry relies on strong education and workforce development, but our state currently ranks 43rd in public university funding. Neighboring states like Illinois and Minnesota are in the top 10.
We invite you to sign a letter calling for increased state funding to bring Wisconsin to the national median. By investing in our universities, we strengthen our biohealth industry and workforce.
Sign the letter by the end of September and help build a vibrant future for Wisconsin.
State & Local Legislative Activities
The Wisconsin State Assembly and State Senate have now concluded their legislative activities for 2024 and will not reconvene until January 2025.
BioForward is committed to supporting Wisconsin’s biohealth industry and had a significant focus to the start of 2024 in completing the EDA’s Phase 2 Regional & Innovation Tech Hub application. On February 21st, Act 96 was enacted providing state matching funds to our Phase 2 application.
BioForward is also committed to our education systems from K-12 to technical colleges to our university system. We continue to utilize our 2022 WI Biohealth Economic Impact Report to demonstrate the importance of our biohealth industry to policymakers on the state and federal levels. This year, we will be investing in a 2024 WI Biohealth Economic Impact Report. Follow 2024 State Legislative and Administrative Actions & Updates for more information.
2024 STATE LEGISLATIVE AND ADMINISTRATION ACTIONS & UPDATES
Tech Hub Matching Funds Legislation (Assembly Bill 916/Senate Bill 894):
On February 21st, Act 96 was enacted (000001.ildoc) (wisconsin.gov), providing $7.5m in matching funds to the WI Biohealth Tech Hub to support its Phase 2 Regional & Innovation Tech Hub application which was submitted to the EDA on February 28, 2024.
This legislation had overwhelming bi-partisan support passing 96-0 in the Assembly and 31-1 in the Senate. It was then enacted by Governor Evers. More information on the Wi Biohealth Tech Hub: https://www.bioforward.org/wisconsin-biohealth-tech-hub/
SUPPORT: All Co-pays Count Legislation
This legislation requires health insurance policies that offer prescription drug benefits, self-insured health plans, and pharmacy benefit managers acting on behalf of policies or plans to apply amounts paid by or on behalf of a person covered under the policy or plan for prescription drugs to any calculation of an out-of-pocket maximum amount or to any cost-sharing requirement of the policy or plan in Wisconsin. For additional information, check out their website at this link WI All Copays Count Coalition (wi4patients.com) and read the recent press release.
Watch this powerful video about why all co-pays count: https://vimeo.com/user13782109/review/818097108/a71ed27fed
SUPPORT: Clinical Trials Legislation (AB 398 / SB 387).
This bill provides that for the purposes of the minimum wage law and worker’s compensation law an individual who is a participant in a clinical research trial and receives remuneration, a stipend, or compensation for participating in the trial is not an employee of the entity that conducts the trial. The bill also provides that such participation is generally not considered covered employment under the unemployment insurance (UI) law. As a consequence, amounts paid by employers for such participation are not subject to UI contribution requirements and are not counted as base period wages for purposes of determining eligibility for UI benefits. This legislation has passed both the Assembly and Senate and BioForward is advocating for the Governor to sign this legislation. https://docs.legis.wisconsin.gov/2023/related/proposals/ab398.pdf
SUPPORT: Protect Our Farms. (AB 957/ SB 892)
This legislation would prevent local governments from enacting animal welfare ordinances in areas zoned for agricultural use – including prohibiting them from restricting what the animals can be used for after they leave the farm or facility. This bill has passed the Assembly and the Senate and is under review by the Governor.
OPPOSE: Gain of Function Legislation (AB 413 / SB 401)
On January 10, the Assembly Committee on Colleges and Universities heard testimony on legislation that would ban the Universities of Wisconsin and the Technical College System from conducting research that could enhance the transmission of pandemic pathogens. Lawmakers authoring the bill said that it would protect Wisconsinites from potentially catastrophic consequences. UW-Madison and the Medical College of Wisconsin provided written testimony in opposition to the bill, arguing it would “significantly hinder the ability of researchers in Wisconsin to conduct research of extreme importance to the state.” They noted a variety of concerns about the legislation, including that the language in the bill is too broad. The definition in the bill applies to “potentially pandemic” pathogens, including viruses, fungi and bacteria the groups argued don’t have pandemic potential. The Senate Committee on Health held a similar hearing on the Senate version of the legislation on January 18, 2024.
2023 STATE LEGISLATIVE AND ADMINISTRATION ACTIONS & UPDATES
BioForward is actively working with Governor Evers and Wisconsin legislators to pass all copays count legislation, an R&D tax credit refundability increase, full repeal of the personal property taxes, and to support the University of Wisconsin System & Technical Colleges.
On Wednesday, July 5th, Governor Evers signed the 2023-2025 State Budget into law as Act 19 (with 51 partial vetoes). We are pleased to have two key issues that BioForward strongly supported included in the State Budget, namely:
Tech Hub Matching Funds Legislation: Representatives from the Wisconsin State Senate and State Assembly have drafted legislation that would secure $7.5 million in state matching funds for the Wisconsin Biohealth Tech Hub’s federal implementation grant. The funding would be designated to support projects aligned with the overarching Tech Hub designation, which would strengthen our EDA Tech Hub Phase II application.
Increased R&D Tax Credit Refundability: The signed budget included a 10% increase in the credit refundability to 25% beginning in 2024, the biggest increase in refundability since the credit was initially made refundable at 10%. The specific language is included in sections 338-340, 342-345 (page 152, here).
Elimination of Personal Property Taxes: The State Budget included a complete elimination of personal property taxes contained in Assembly Bill 245, now 2023 Wisconsin Act 12 related to shared revenue. The 2023 Wisconsin Act 12 was signed into law on June 21, 2023, to take effect on January 1, 2024. The specific language included is on page 2 and page 5, SECTION 24. 60.85 (1) (f), SECTION 25. 60.85 (1) (h), and SECTION 26. 60.85 (1) (o), (here).
These budget outcomes mean that our member companies will be able to reinvest the tax savings back into their businesses. BioForward is proud to have helped deliver these wins to our industry and will stay committed to actively advocating for changes that help our industry grow.
SUPPORT: Coverage of Breast Cancer Screenings by Health Insurance Policies (SB 121)
This bill requires health insurance policies to provide coverage with no patient cost-sharing for supplemental breast screening examinations or diagnostic breast examinations for an individual who is at increased risk of breast cancer, as determined in accordance with the most recent applicable guidelines of the National Comprehensive Cancer Network. SB 121 ensures that men and women, regardless of socio-economic background, have access to life-saving breast imaging.
SUPPORT: All Co-pays Count Legislation
This legislation requires health insurance policies that offer prescription drug benefits, self-insured health plans, and pharmacy benefit managers acting on behalf of policies or plans to apply amounts paid by or on behalf of a person covered under the policy or plan for prescription drugs to any calculation of an out-of-pocket maximum amount or to any cost-sharing requirement of the policy or plan in Wisconsin. For additional information, check out their website at this link WI All Copays Count Coalition (wi4patients.com) and read the recent press release.
Watch this powerful video about why all co-pays count: https://vimeo.com/user13782109/review/818097108/a71ed27fed
SUPPORT: Increase in Refundable Research Tax Credit
BioForward is a coalition member working to increase the Wisconsin Refundable Research Credit from 15% to a higher limit. More details to be provided as updates occurred through the state budget process. For current information on the Wisconsin Research credits, click on the link: https://www.revenue.wi.gov/Pages/Businesses/incentives-research.aspx.
SUPPORTED: Complete Repeal of the Personal Property Tax (AB 245) now 2023 Wisconsin Act 12
Gov. Tony Evers has signed Assembly Bill 245, now 2023 Wisconsin Act 12 into law, completely repealing Wisconsin`s Personal Property Tax. BioForward strongly supported and advocated for the passage of this bill because it saves our biohealth companies and Wisconsin businesses over $200 million annually in tax relief allowing them to reinvest the tax savings back into their companies. Here is a link to the 2023 Wisconsin Act 12: https://content.govdelivery.com/attachments/WIGOV/2023/06/20/file_attachments/2531011/ab245.pdf. The repeal of the Personal Property Tax is mentioned on page 2 and on page 5 SECTION 24. 60.85 (1) (f), SECTION 25. 60.85 (1) (h), and SECTION 26. 60.85 (1) (o).
SUPPORT: Increase Funding to the UW System including:
Funding for the UW-Madison College of Engineering Building Project. Click here to support!
Funding for Phase II of the University of Wisconsin-Eau Claire Science and Health Sciences Building to ensure that UW-EC continues its traditions as a national leader in undergraduate research. It will be a catalyst for talent and workforce development for northwest Wisconsin.
Senate and Assembly Republicans Elect Leadership for 2023-24:
Senate Republican Leadership
- Senate President – Chris Kapenga
- Senate President Pro Tempore – Patrick Testin
- Majority Leader – Devin LeMahieu
- Assistant Majority Leader – Dan Feyen
- Caucus Chair – Van Wanggaard
- Caucus Vice-Chair – Joan Ballweg
Assembly Republican Leadership
- Assembly Speaker – Robin Vos
- Assembly Speaker Pro Tempore – Kevin Petersen
- Majority Leader – Tyler August
- Assistant Majority Leader – Jon Plumer
- Caucus Chair – Rob Summerfield
- Caucus Vice-Chair – Cindi Duchow
- Caucus Sergeant at Arms – Treig Pronschinske
STATE GOVERNMENT UPDATES:
- Gov. Ever Appoints Kirsten Johnson to DHS Secretary: Press Release: Gov. Evers Appoints Kirsten Johnson to DHS Secretary (govdelivery.com)
- 2023 -24 School Year Immunization Requirement: Immunization: 2023 Child Care and 2023-2024 School Year Immunization Requirements | Wisconsin Department of Health Services
2023 LEGISLATIVE RESOURCE
BIO Vaccine Education Materials
2022 WISCONSIN ELECTION RECAP
November 11, 2022
Wisconsin Reelects Governor Tony Evers to a Second Term.
Democratic incumbent Governor Tony Evers captured 51.2% of the vote, while Republican challenger, Tim Michels, had 47.79%. According to reporting by WisPolitics, Evers has broken several historical trends with this victory. He is the first gubernatorial candidate to win a race while his party was in the White House since Republican Tommy Thompson in 1990. He is also the first Democrat to pull it off in 60 years.
Attorney General Dem Josh Kaul is Reelected.
Democratic incumbent Attorney General, Josh Kaul won reelection by narrowly beating Republican challenger, Fond du Lac County District Attorney, Eric Toney. With 99 percent of votes counted, Kaul had 50.1% to Toney’s 49.9%. This is an even slimmer margin than the 0.25% margin that Kaul beat Republican Attorney General Brad Schimel by in 2018.
Ron Johnson wins US Senate Reelection.
In the battle for Wisconsin’s U.S. Senate seat on the ballot, incumbent Republican Senator Ron Johnson beat Democratic challenger, Lt. Gov. Mandela Barnes. Johnson secured 50.50%, while Barnes captured 49.50% of the vote.
Republican Majority in the State Senate will be 22-10 Next Session.
The Senate Republicans have picked up their 2/3 veto-proof majority with a 22-11 majority heading into the 2023-24 legislative session. However, because the Assembly came up short, the legislature will not have a veto-proof Republican majority.
State Assembly Republican Majority will be 64-35.
The Wisconsin State Assembly will reconvene with a 64-35 majority in January 2023. Although they picked up three seats, they are still two seats short of the veto-proof majority that they were seeking.
Republican Van Orden Wins Open 3rd Congressional District.
The race for the open 3rd Congressional District vacated by Dem Congressman Ron Kind’s retirement was won by Republican former Navy SEAL Derrick Van Orden who beat Democratic candidate State Senator Brad Pfaff. Senator Pfaff will return to his State Senate seat, as his seat was not up for reelection in this year.
Key Wisconsin State Senate Races:
- Republican Rob Hutton won the 5th State Senate District left open when current State Senator Dale Kooyenga decided not to run for reelection.
- Republican State Rep. Rachel Cabral-Guevara will move to the Wisconsin State Senate, winning her race for the 19th State Senate District, which was vacated by Republican Lt. Gov candidate Roger Roth.
- Former Republican State Rep. Romaine Quinn wins the 25th State Senate District seat, which was vacated by retiring Democratic State Senator Janet Bewley.
- Republican candidate Cory Tomczyk wins the 29th Senate District vacated by retiring Republican State Senator Jerry Petrowski.
Other WI Congressional Race Results:
- S. Rep. Bryan Steil, R-Janesville, won reelection against Dem Ann Roe.
- S. Rep. Mike Gallagher, R-Allouez, won reelection against independent Paul Boucher and Libertarian Jacob VandenPlas.
- S. Rep. Tom Tiffany, R-Minocqua, won reelection against Dem Richard Ausman.
- S. Rep. Glenn Grothman, R-Glenbeulah, was unopposed.
- S. Rep. Scott Fitzgerald, R-Juneau, won reelection against Dem Mike Van Someren.
- S. Rep. Mark Pocan, D-Town of Vermont, won reelection against Republican Erik Olsen and Independent Douglas Alexander.
- S. Rep. Gwen Moore, D-Milwaukee, won reelection against Republican Tim Rogers.
Senate and Assembly Republicans Elect Leadership for 2023-24. The day after the election, the Wisconsin State Senate and Assembly Republican caucuses met separately to elect the following leaders for the 2023-24 legislative session:
Senate Republican Leadership
- Senate President – Chris Kapenga
- Senate President Pro Tempore – Patrick Testin
- Majority Leader – Devin LeMahieu
- Assistant Majority Leader – Dan Feyen
- Caucus Chair – Van Wanggaard
- Caucus Vice-Chair – Joan Ballweg
Assembly Republican Leadership
- Assembly Speaker – Robin Vos
- Assembly Speaker Pro Tempore – Kevin Petersen
- Majority Leader – Tyler August
- Assistant Majority Leader – Jon Plumer
- Caucus Chair – Rob Summerfield
- Caucus Vice-Chair – Cindi Duchow
- Caucus Sergeant at Arms – Treig Pronschinske
2022 STATE LEGISLATIVE AND ADMINISTRATION ACTIONS & UPDATES
BioForward State Advocacy Update – Preview of 2023
Wisconsin has reelected Democratic Governor Tony Evers for his second term. At the same time, the State Assembly and the State Senate will have very strong Republican majorities in 2023. With a Democratic governor and a Republican legislature, Wisconsin will have a “divided government” in the state legislature again for the upcoming 2023-24 legislative session.
In January 2023, the Governor will immediately begin work on the next biennial budget bill and the legislature will be in session and will work on numerous legislative issues. Although no specific legislation can be introduced until January, below is a preview of the issues that are on the state advocacy priority list for BioForward for the 2023-24 Wisconsin legislative session:
2023-25 Biennial Budget Bill – Support for UW and Support for Wisconsin Businesses.
The biennial budget bill controls the spending for the State of Wisconsin for the next two fiscal years. This bill will cover all state expenditures from July 1, 2023, through June 30, 2024. BioForward is particularly interested in any tax issues that could affect our Wisconsin companies and also the funding and support provided to public education, support to STEM education, the University of Wisconsin system and UW-Madison by the state in this legislation.
Support the Repeal of Personal Property Tax.
BioForward has supported efforts to repeal Wisconsin’s personal property tax for the past two sessions. The PPT imposes an unequal local tax burden on small business across Wisconsin. The “personal property tax” is a business tax that is assessed and collected by some local municipalities on certain property located within a business. It has become an administrative and financial burden that does not generate a very large or considerable revenue amount. As such, a very large coalition of businesses from across industry sectors has come together to work toward repealing this tax. It has strong bipartisan support and hopefully will be approved in 2023.
Support Legislation to Prohibit Co-Pay Accumulators – Help Patients Afford Medication at the Pharmacy Counter.
Copay accumulator provisions in health insurance policies exclude copay assistance from counting toward a patient’s deductible or out of pocket costs. If a patient has an insurance plan with a “copay accumulator” program, the part of their copay that is paid by a prescription drug manufacturer’s copay assistance program will be accepted at the pharmacy and used toward the cost of the medication but that money will not count toward their deductible or their annual maximum out-of-pocket costs. BioForward is a part of a coalition of patient advocacy groups and manufacturers who are working to pass legislation to prohibit this practice in Wisconsin. To date, fourteen states have already banned accumulator provisions.
Carefully Monitor and Engage on any Prescription Drug Pricing Transparency Initiatives.
We have seen various legislative proposals introduced over the past several sessions aimed at increasing prescription drug pricing transparency. Because of the complexity of these proposals and their consequences, we carefully monitor these issues and will engage with the input and guidance of our members, as needed.
Attorney Jordan Lamb serves as BioForward’s lead legal and legislative counsel. Successful management of governmental issues for BioForward depends on our comprehensive approach to the unique challenges ranging from health policy to business issues that are faced by Wisconsin biohealth businesses. Our approach to each issue depends on a combination of legal analysis, statute and rule design, constituency involvement, political action and media management.
Madison Local Issue
OPPOSE: City of Madison Proposes Ban on Breeding and Selling Animals for Research.
The proposed ordinance item #68608, related to a ban on breeding and selling animals for research, was not included in the agenda for the Board of Health (BOH) meeting on 9/7. Currently, this matter has been placed on file and no timetable for further BOH review. BioForward and the Biohealth community, including UW-Madison, aggressively advocated against this ban.
The proposed City of Madison ordinance that had been pending before the Dane County Board of Health since January 2022, could have negatively affected our local (Madison/Dane County) research and biohealth community. Two alders from the Madison City Council: Proposed Ordinance No. 68608 which would have banned the breeding or selling of vertebrate animals for the purpose of medical, surgical or chemical experimentation in the City of Madison.
2022 State Issues
SUPPORT: Co-pay Accumulator Legislation (2021 SB 215/AB 184)
- FAILED TO PASS (2021 SB 215 and AB 184). This legislation requires health insurance policies that offer prescription drug benefits, self-insured health plans, and pharmacy benefit managers acting on behalf of policies or plans to apply amounts paid by or on behalf of a person covered under the policy or plan for prescription drugs to any calculation of an out-of-pocket maximum amount or to any cost-sharing requirement of the policy or plan in Wisconsin.
- The Assembly Health Committee held a public hearing on AB 184 on February 16, 2022. There was no hearing in the Senate Committee and no vote on this legislation in the Assembly Committee. BioForward will work to support this legislation again during the 2023-24 legislative session.
- SUPPORTED-Engineering School Planning Bill PASSES (AB 775 / SB 728). Legislation to require the Building Commission to allocate $1,000,000 from the state building trust fund to conduct planning and design services and prepare a design report for the construction of a new engineering building at the University of Wisconsin-Madison passed both houses and was signed by Governor Evers on March 18, 2022 https://content.govdelivery.com/attachments/WIGOV/2022/03/18/file_attachments/2107255/ab775.pdf
- SUPPORTED-Qualified New Business Venture Eligibility Changes PASSES (AB 759 / SB 729). Legislation that would help Wisconsin-based start-ups who acquire another business from outside of Wisconsin not lose their Early-Stage Investment Tax Credits due to their expansion has passed both houses and will be sent to the Governor. Current law requires companies to have at least 51% of their employees in Wisconsin in order to qualify for the credit. Under this bill, the company would be allowed one calendar year from acquisition in which they could drop below the 51% threshold and still qualify for the tax credit. Business’ headquarters must remain in Wisconsin and all current Wisconsin employees remain in Wisconsin as well.
Federal Legislative Activities
A key value we bring our members is to advocate not only on a state level but on federal issues that affect Wisconsin’s biohealth industry and research institutions. We have strategic collaborations with partners such as the Biotechnology Innovation Organization (BIO), Pharmaceutical Research and Manufacturers of American (PhRMA), and the Advanced Medical Technology Association (AdvaMed) who serve to advance legislative policies having the greatest impact on Wisconsin’s biohealth ecosystem.
2024 FEDERAL LEGISLATIVE ACTIONS
Support: Ensuring Patient Access to Critical Breakthrough Products Act of 2023; H.R. 1691
This bill provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.
Support: BioForward once again supports restoring the longstanding deduction for R&D expenditures which was changed in 2022 to a mandatory five-year amortization for domestic R&D. This greatly impacts emerging growth companies that depend on expensing the R&D expenditure in the year incurred. (H.R.2673 S.866)
Update: The House Ways & Means Committee approved the Small Business Jobs Act (H.R. 3937), which includes language to delay retroactively through 2025 the mandatory capitalization of R&D expenses.
BioForward appreciates Senator Tammy Baldwin for co-sponsoring S.866. BioForward appreciates Representative Glenn Grothman (WI-06) for co-sponsoring H.R. 2673.
2023 FEDERAL LEGISLATIVE ACTIONS
Support: The Pandemic All Hazards Preparedness Act (PAHPA) Reauthorization Bills:
PAHPA establishes measures to prepare for the next pandemic, biothreats, and public health emergencies. Existing authorities expire on Sept. 30, 2023.
Update: The Pandemic All Hazards Preparedness Act (PAHPA) reauthorization bills has moved forward with committees in the House and Senate approving their respective proposals. Incentives included in the bills will promote research into medical countermeasures (MCMs), including an extension of the MCM priority review voucher, technologies to support vaccine development and manufacturing, as well as amendments to reduce unnecessary reporting requirements for the Strategic National Stockpile and to establish a program for reviewing MCMs for emerging pathogens at the FDA.
Our national partners, AdvaMed and BIO, are conducting meetings to update federal legislators on our industry and federal agenda for the 118th United States Congress. More details to come as additional information are provided.
3/23. BioForward once again supports restoring the longstanding deduction for R&D expenditures which was changed in 2022 to a mandatory five-year amortization for domestic R&D. This greatly impacts emerging growth companies that depend on expensing the R&D expenditure in the year incurred. (H.R.2673 S.866)
Update: The House Ways & Means Committee approved the Small Business Jobs Act (H.R. 3937), which includes language to delay retroactively through 2025 the mandatory capitalization of R&D expenses.
BioForward appreciates Senator Tammy Baldwin for co-sponsoring S.866. BioForward appreciates Representative Glenn Grothman (WI-06) for co-sponsoring H.R. 2673.
4/23. Support: Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 2407)
Cancer is surpassing heart disease as the leading cause of death in America because we find most cancers too late. Since Medicare covers those at greatest risk for cancer – America’s seniors – the program should allow access to life-saving cancer screenings once approved by the FDA and evaluated by CMS.
This legislation would give CMS a direct path to cover multi-cancer screenings following FDA approval without compromising their administrative discretion. By passing this bill, Congress would build on a legacy of bipartisan action, having previously enacted coverage pathways for mammography, pap smears, and prostate and colorectal cancer screenings. Absent Congressional approval, Medicare coverage of MCED technologies could be unnecessarily delayed for many years following FDA approval, and the vast majority of seniors would struggle to access these screenings during that time. In addition, increasing early detection will reduce late-stage treatment costs and realize savings for Medicare and seniors, ultimately changing the long-term trajectory of cancer spending.
BioForward appreciates Representative Mark Pocan (WI-02) for co-sponsoring H.R.2407
6/13. Support: Efforts by the Partnership to Fight Chronic Disease (PFCD)
BioForward supports efforts by the Partnership to Fight Chronic Disease (PFCD) and other partnered organizations to urge the Centers for Medicare and Medicaid Services (CMS) to reconsider its National Coverage Decision requiring Coverage with Evidence Development for an entire class of Alzheimer’s disease therapies. This decision has ripple effects beyond just the Alzheimer’s community and sets a dangerous precedent for other people living with chronic conditions.
2022 FEDERAL LEGISLATIVE ACTIONS
2022 Federal Issues
November 2022
Oppose: World Health Organization’s proposal and the Biden Administration support of Trade-Related Aspects of Intellectual Property Rights (TRIPS). MC12 TRIP Waiver on COVID-19 Therapeutics & Diagnostics
Wisconsin biohealth businesses employ more than 129,000 people statewide and are extremely dependent on research and development with intellectual property rights in place to appropriately protect the successes of this industry. Unfortunately, WHO is proposing to expand TRIPS covering not only vaccines but also COVID therapeutics. BioForward is opposed to this expansion.
This waiver expansion under consideration is inconsistent with the Biden Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, issued on September 12, 2022. The TRIPS waiver expansion would fundamentally undermine a key objective of the Executive Order itself, which is to ensure United States global leadership in the field of biotechnology. See related op-ed for more information.
Support: Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946/S. 1873)
Cancer is surpassing heart disease as the leading cause of death in America because we find most cancers too late. Since Medicare covers those at greatest risk for cancer – America’s seniors – the program should allow access to life-saving cancer screenings once approved by the FDA and evaluated by CMS.
This legislation would give CMS a direct path to cover multi-cancer screenings following FDA approval without compromising their administrative discretion. By passing this bill, Congress would build on a legacy of bipartisan action, having previously enacted coverage pathways for mammography, pap smears, prostate, and colorectal cancer screenings. Absent Congressional approval, Medicare coverage of MCED technologies could be unnecessarily delayed for many years following FDA approval, and the vast majority of seniors would struggle to access these screenings during that time. In addition, increasing early detection will reduce late-stage treatment costs and realize savings for Medicare and seniors, ultimately changing the long-term trajectory of cancer spending.
September 2022
Ongoing-Support SBIR/STTR Reauthorization
- Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs were set to expire on September 30, 2022. SBIR and STTR are an essential part of America’s Innovative high-tech ecosystem. Any disruption to this system could have had a severe effect on R&D-focused small businesses. BioForward supported both AdvaMed and BIO’s legislative advocacy to achieve the reauthorization of these vital programs. Wisconsin’s stats: Over $114,000,000 in SBIR/STTR grants from 2017—2021.
- On September 30, 2022, President Biden signed the SBIR and STTR Extension Act of 2022, reauthorizing the SBIR/STTR programs to continue through fiscal year 2025.
- September 20th, Senate Reauthorized funding and moved to House for final funding authorization: https://www.bioforward.org/2022/09/21/good-day-bio-sbir-sttr-passes-senate-moves-to-house/
Supported Prescription Drug User Fee Act (PDUFA) VII Reauthorization
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. This new law includes the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.
https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027
Supported Medical Device User Fee Amendment (MDUFA) V Reauthorization
On September 30, 2022, the President signed into law the five-year reauthorization of the Medical Device User Fee Amendment (MDUFA) agreement, the fifth iteration of this user-fee agreement since the system’s implementation in 2002. It provides FDA with the resources it needs to review device submissions in a timely, efficient, and cost-effective way. https://www.advamed.org/industry-updates/news/congress-passes-historic-mdufa-v-reauthorization/
7/22 Oppose Drug Price Control Legislation that would alter the Medicare program
Supporting BIO’s coalition in opposition. https://www.bio.org/press-release/new-drug-pricing-deal-could-propel-us-light-years-back-dark-ages-biomedical-research. Helpful information pertaining to this subject can be found at:
6/22. Supported BIO’s legislative advocacy to restore the longstanding deduction for R&D expenditures which was recently changed to a mandatory five-year amortization for domestic R&D
4/22. Supported The Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946) a S. 1873
Aimed to overcome access hurdles by allowing a pathway for timely coverage of multi-cancer early detection tests once they are approved by the Food and Drug Administration (FDA).
3/22 Supported The Bayh-Dole Coalition, arguing against government-imposed arbitrary price controls
Joined the coalition in urging the Department of Health and Human Services to reject once again the petition asking the federal government to grant march-in rights for the patents on Xtandi, a prostate cancer drug, because of its price.
BioForward Advocacy News
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Bipartisan bill would ensure copay aid goes to patients’ out-of-pocket cost for medications in Wisconsin
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Bipartisan bill aims to help with prescription drug costs
Proposed legislation would require Wisconsin insurance plans and pharmacy benefits managers to accept co-pay assistance towards annual drug...
Lawmakers Introduce All Copays Count Legislation
MADISON (WKOW) -- Right now, Wisconsin lawmakers on both sides are working to ensure co-pay assistance programs benefit patients instead of...
Public Policy Team
Jordan Lamb
Lisa Johnson
Government Affairs Committee
Sandra Benen
Director State Government Affairs, GSK
Hollis Cloninger
Director Quality and Compliance, Eurofins
Peter Fotos
Deputy Vice President, State Advocacy, PhRMA
Dee (Dodge) George
Assistant Director, State Govt. Affairs, Novartis
Sarah Waun
Senior Manager, State Govt. Affairs, Genentech
Kevin Johnson
Senior Manager, State Govt. Affairs, Amgen
Lisa Johnson
CEO, BioForward
Jordan Lamb
Legislative Counsel, The Welch Group
Amber Pearce Shaw
Government Affairs, Exact Sciences
Charles Neider
President, Neider & Boucher, S.C.
Nicolas Paris
CEO, Gilson
Kathy Voskuil
Global Policy & Public Affairs-Alliance Development, Pfizer
Zachary Taylor
Senior Director Operations, Catalent
Kevin Walters
Public Affairs Analyst, WARF
Find Your Legislators & Legislative Committees
BioForward periodically sends out legislative alerts asking members to contact their senators or representatives on issues of importance to the biohealth industry. You can find them on the map.
2023-24 Wisconsin Assembly Standing Committees
2023-24 Wisconsin Senate Standing and Joint Committees Members