FEDERAL AFFAIRS
CURES Act 2.0 Released
U.S. Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) released draft legislation that includes, among other measures, a provision that proposes to create an Advanced Research Projects Agency for Health, or ARPA-H, and would be largely modeled after the military’s Defense Advanced Research Projects Agency, or DARPA. The latter has been responsible for successfully developing some of the most significant technological advancements of our time, including the Internet, GPS and self-driving cars.
The draft bill now circulating among lawmakers is known as Cures 2.0. It seeks to build upon the tremendous success that Reps. Upton and DeGette had in 2015 with the passage of their 21st Century Cures Act, a landmark piece of bipartisan legislation that revolutionized how the U.S. researches and develops new pharmaceuticals and medical devices to treat some of the most challenging diseases.
In addition to the creation of ARPA-H, Cures 2.0 proposes to:
- Improve how Medicare covers innovative new health care technologies
- Increase diversity in clinical trials to ensure new drugs and treatments are both safe and effective for a greater majority of patients.
- Require FDA to expand the collection and use of Real World Evidence to aid in the development of new, patient-focused treatment approaches.
- Provide training and educational programs for caregivers to help improve the quality of care patients are provided at home, between clinical visits.
- Provide patients greater access to more health information to improve their understanding of the illness they face and make them a more integral part of the decision-making process when assessing which course of treatment is best for them.
- Increase access to telehealth services for patients covered under Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to make these services more accessible to more Americans.
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H.R. 3
MichBio, along with Michigan partners (MI Lupus Foundation, MI Building & Construction Trades Council, American Arab Chamber of Commerce, and MI Osteopathic Association) sent a letter to the MI Congressional delegation describing our opposition to H.R. 3 that, among other measures, would require government price negotiation and international reference price setting.
In addition, MichBio joined a CSBA (Council of State Bioscience Associations) letter to Congressional leadership about our strong concerns to H.R. 3 and the proposed foreign price controls. The worry is that such a measure would have a chilling effect on future drug innovation and development.
MichBio and other state bio groups that make up the ad hoc Life Sciences Regional Trade Association group are planning a Congressional briefing for this summer to spotlight the potential impact of H.R. 3 if enacted on biomedical innovation and commercialization, as well as drug access and affordability.
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White House Seeks TRIPS Waiver
MichBio reached out to MI members of the House Ways & Means Committee and Senate Finance Committee with our opposition to the President's proposal seeking a waiver of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement through the WTO.
The suspension of IP rights on Covid vaccines would be precedent-setting and runs the risk of invoking such a measure with other patented medicines. Such steps would lead to great harm for patients, diminish drug development and innovation, increase counterfeiting, lead to shortages of critical drugs, and all the while not substantially increase supply and access to needed Covid vaccines.
MichBio is working with other state and national partners in opposition to the TRIPS waiver request.
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FTC Ponders Pharma (and Biotech) Mergers
The Federal Trade Commission, along with its counterparts in Canada, Europe and UK, as well the U.S. Department of Justice Antitrust Division and Offices of State Attorneys General, formed a multilateral task force to update their approaches assessing the effects of pharmaceutical mergers. The workgroup issued a request for public input and the deadline closed June 25, 2021.
Basically, the question boils down to this…are pharma mergers bad for biotech? A myriad of parties have differing views on the topic. Some believe that big pharma mergers destroy the innovative culture of small biotechs, all in a selfish interest to maximize profits and block competition. Others, like our national partner, BIO, argue that the FTC is already capable of dealing with mergers, and that the biopharma investment ecosystem has evolved and there’s no turning back on the model – namely, small biotech are responsible for 80% of all scientific R&D and large companies fill their development pipelines with such substrate.
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STATE AFFAIRS
Creation of Rare Disease Advisory Council Proposed.
Rep. Cara Clemente (D-Wyandotte) introduced legislation, HB 4654, that calls for the formation of a Michigan Rare Disease Advisory Council (RDAC).
The Council, if enacted, would identify the rare diseases prevalent in Michigan, their cost to the state’s healthcare system and patients, determine challenges facing caregivers and patients dealing with rare diseases, and report to the legislature with recommendations for policy changes that can address those needs. The body would be established within the Department of Health & Human Services, and as proposed, consist of 9 members.
MichBio provided written testimony before the House Health Policy Committee that called for expansion of the Council to include a larger number of patient rare disease representatives as well as a genetic counselor, among other changes.
Subsequently, Committee Chair Bronna Kahle, called together a small workgroup, that included MichBio, to address some of the concerns raised by various stakeholders. A resulting substitute was developed and the revised language is circulating among lawmakers. The measure is likely to return for a Health Policy vote in fall 2021.
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PILMA Report on Impact of Trades Workforce in Growing Michigan’s Biopharma Sector
The Pharmaceutical Industry Labor-Management Association (PILMA) released a report on the economic impact of the long-standing partnership between skilled craft unions and the biopharmaceutical industry in Michigan and 13 other states.
The report found that Michigan building trades helped drive $1.12 billion in investment on major construction projects (over $5 million) active at any point between 2015 and 2021. During the same time period, skilled craft union worker earnings in Michigan reached more than $25 million – representing more than 906,000 hours of work – in addition to significant funding for union health insurance and pension benefits. Updated from a study between 2012 and 2017, the study shows a steady growth in investment from the biopharmaceutical industry both in Michigan and in the US – with the investment and earnings growing every year since 2015.
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Michigan Biosciences Legislative Caucus
Reps. Felicia Brabec (D-Ann Arbor) and Bronna Kahle (R-Adrian) will serve as House co-chairs of the Michigan Biosciences Legislative Caucus. They join Sens. John Bizon (R-Battle Creek) and Mallory McMorrow (D-Rochester) to provide leadership of the caucus. A formal announcement of the new leadership is forthcoming.
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Michigan Biosciences Day at the Capitol
MichBio held a virtual Capitol Day wherein 30 representatives from member organizations joined us in conversations with legislative offices. A record number of 103 meetings were held – some 70% of the legislature – an amazing turnout and opportunity.
In addition to educating legislators and staff about Michigan’s biosciences industry and its impact on the economy and citizens, participants pitched a number of priorities including reestablishing an R&D tax credit for small to mid-size companies, opposing cuts to higher education funding for the three major research universities, supporting the creation of an RDAC (see above), developing leading-edge, analytical compliance standards for cannabis, and placing more focus on bioscience talent and workforce development.
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