Policy & Advocacy
Through education and advocacy, MassBio promotes thoughtful legislative and regulatory solutions that give Massachusetts life sciences companies the best environment possible to research, develop, and commercialize breakthrough therapies and cures, and that ensure patients around the world have equitable, affordable access to those new treatments. Likewise, we oppose policies that threaten patient access, limit innovation, or hurt the Massachusetts life sciences industry’s competitiveness in the global economy.
When government, industry, and academia work together, our industry thrives and patients around the world benefit. MassBio is here to ensure that the relationship is strong, lasting, and mutually beneficial.
Policy News & Legislative Updates
MassBio reguarly issues statements about our position on a variety of state and federal policy proposals that impact our industry, our members, and patients. Check out this week’s policy update and subscribe to our Insider newsletter to receive the latest industry news.
Week of September 25, 2023 — Legislative Update
- The bi-partisan Optimizing Research Progress Hope And New Cures (ORPHAN) Cures Act was introduced to change the incentive structure within the IRA to encourage follow-on investment into orphan drug development. (Good Day BIO)
- The House Committee on Oversight and Accountability held a hearing on the role of PBMs in prescription drug markets, during which Chair James Comer (R-KY) blasted “spread pricing, where PBMs overcharge payers and underpay pharmacies, and pocket the extra money.” (house.gov)
- Healthcare and government leaders support legislation filed by the Health Equity Compact, a group of more than 80 leaders of color, to address health disparities in the state. (Boston Globe)
- Massachusetts legislative leaders said Thursday they have reached an agreement on a tax relief bill after months of closed-door negotiations. (Boston Globe)
- A new center at Northeastern will track infectious diseases and provide outbreak forecasts to communities, sort of like a "National Weather Service for epidemics,” thanks to $17.5M CDC grant. (Boston.com)
Week of September 18, 2023 — Legislative Update
- The U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.
- The White House announced new actions to advance the Cancer Moonshot, including $240 million in funding for the Advanced Research Projects Agency for Health (ARPA-H) to “accelerate new ways to prevent, detect, treat, and survive cancer.” (White House Fact Sheet | ARPA-H Release)
- The Congressional Budget Office (CBO) released a cost estimate for H.R. 5378, the Lower Costs, More Transparency Act, legislation to “increase health care price transparency and lower overall costs for patients and employers.” (CBO website | Section-by-Section)
- CBO estimated that changes in direct spending and revenues as a result of the legislation would reduce the deficit by $833 million from 2023-2033, including a $369 million increase in the on-budget deficit, and a $1.202 billion decrease in the off-budget deficit.
- MassBio’s Kendalle Burlin O’Connell joined leaders of Massachusetts business and trade associations to write in support of the request made to the Biden-Harris Administration by Governor Maura Healey to address the “state of emergency” relative to migrants entering the Commonwealth. (Read the letter)
- The Health Policy Commission published the latest in a series of annual health care cost trends reports, showcasing a wide range of data points and making nine policy recommendations. (SHNS)
Week of September 11, 2023 — Legislative Update
- The Centers for Medicare and Medicaid Services (CMS) has announced a series of Patient-Focused Listening Sessions scheduled for this Fall as part of the Medicare Drug Price Negotiation Program. The Listening Sessions will be held October 30 – November 15, 2023 and “will provide an opportunity for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to the drugs selected for the first round of negotiations.”
- Senate HELP Committee Ranking Member Bill Cassidy, M.D. (R-LA) delivered a Senate floor speech on the “so called” Inflation Reduction Act (IRA) and he talks about his trip to Massachusetts in June. Senator Cassidy visited small biotech firms and learned more about the negative impacts of the IRA on small and mid-sized biotech companies. (Press Release)
- Alexion’s Scott Weintraub writes about the IRA’s impacts on Boston biotechs in an op/ed in the Boston Business Journal saying “now is not the time to put the brakes on rare disease research and development…Given the significant leaps that the biotech industry has made in recent years, especially in gene and cell therapies, the Boston biotech community is on the cusp of even more life-changing developments for patients.” (BBJ)
- The final version of the “Lower Costs, More Transparency Act” — new bipartisan legislation “to increase health care price transparency and lower overall costs for patients and employers” — has been introduced by House Committee chairs. The bill, which incorporates provisions advanced by three committees, “will provide patients with accurate and timely information about the cost of important health care procedures and services.” (Press Release)
- The Greater Boston Chamber of Commerce and the Massachusetts Society of CPAs recently released a joint statement urging lawmakers to “quickly finalize the first step in strategic tax reform that will benefit residents, families, businesses, and the economy.” (SHNS)
Week of August 28, 2023 — Legislative Update
- Last week, the MBTA announced they plan to shut down part of Red Line for repairs in October. The 16-day shutdown will impact the Ashmont Branch between JFK/UMass and Ashmont stations and the Mattapan Line between Ashmont and Mattapan stations (nbcboston)
- Last week, AstraZeneca became the latest pharma company to sue over the drug pricing provisions in the IRA, raising concerns over 'unintended consequences' in rare disease R&D. (FiercePharma)
- This week, the Biden administration is set to name the first 10 drugs selected for the IRA’s drug price negotiation program. According to Politico, the announcement is expected to come on Tuesday ahead of an event at the White House. (Politico)
Week of August 21, 2023 — Legislative Update
- Last week, Attorney General Andrea Campbell announced $1.5 million in grant funding to 11 community organizations and health centers in a bid to expand maternal health workforce and access to care (State House News)
- Nurse assistant exams to be offered in languages other than English, opening career pathways for non-native speakers (State House News)
- The new language options were included in a policy section within the fiscal 2024 budget that was signed by the Governor this month, but lawmakers say it is only the first step in breaking down barriers for immigrant CNAs and improving care for nursing home residents who don't speak English.
- Last week, Congresswoman Lori Trahan released a report detailing the impact of the Inflation Reduction Act (IRA) and the American Rescue Plan Act (ARP) on residents of the Third Congressional District.
- As a result of the IRA, Medicare beneficiaries’ out-of-pocket insulins costs are now capped at $35 a month, and the ARP strengthened Medicaid’s ability to limit drug price increases starting in 2024.
Week of August 14, 2023 — Legislative Update
- Last week, the Cambridge City Council took no action on Councilor Zondervan’s proposed BEUDO amendment setting 2030 as the net zero deadline for new, large buildings; the proposed amendment is expected to be taken up in September on a date TBD.
- Read MassBio’s comment letter in opposition to this amendment.
- With the signing of the budget, the Department of Public Health (DPH) has 180 days to develop a tiered system for transporting patients to hospitals that have various designations for providing stroke care. Stroke is the sixth leading cause of death in Massachusetts. (State House News)
- Without the investment and expertise of the biopharmaceutical industry, the knowledge gained through research by NIH may generate interesting ideas, but very few, if any, new medicines. (PhRMA Blog)
- What they’re saying: “There is a risk if we were to add some limitations in the contracting that we limit the number of companies that are willing to come forward and do this work,” said Dawn O’Connell, the United States Department of Health and Human Services assistant secretary for preparedness and response, at a recent hearing.
- Drugmakers were incentivized to get drugs on the market as fast as possible, regardless of which disease they would be approved to treat, writes STAT about an interview with Genentech CEO Alexander Hardy, but the Inflation Reduction Act’s new Medicare negotiation program could cause companies to prioritize indications with larger patient populations. (STAT)
- What they’re saying: "We face a lot of difficult decisions to make squaring the science and the societal patient unmet need together with the business case. It’s frustrating that this is an artifact of government legislation, which is creating a disincentive for us to do the right thing for patients,” Hardy said in an interview with STAT.
Week of August 7, 2023 — Legislative Update
- Gov. Maura Healey said Wednesday that she's "anxious to work on a tax package" after the Legislature delivered to her an overdue spending plan that left a blank line item for long-promised tax relief. (SHNS)
- Life sciences industry leaders are also awaiting a forthcoming tax relief proposal, which is not reflected in the Legislature's compromise budget. The budget designates $580 million to cover the costs of that proposal, which remains in a conference committee. (Boston Business Journal)
- In comments to a Senate working group, BIO says that the 340B Program has grown exponentially as hospitals take advantage of the opportunity to profit from drug discounts while the low-income and uninsured patients the program was meant to serve do not benefit. (Bio.News)
- Voters hold a favorable opinion of biotechnology (62 percent) and 67 percent said they support “government policies that seek to address the country’s challenges (i.e. food insecurity, climate change) through innovation in biotechnology.” (Bio.News)
Week of July 31, 2023 — Legislative Update
- Legislative negotiators filed a compromise $56.2 billion annual state budget Sunday night that was approved by the House and Senate on Monday. (State House News)
- Last week, top Democrats proposed legislation that would expand the number of drugs subject to government price negotiations. (Bloomberg Law)
- House and Senate Committees advanced legislation to control the way pharmacy benefit managers (PBMs) can profit by increasing drug prices. (Good Day Bio)
- Dr. Ted W. Love, current chair of the BIO board, writes in an op-ed how the new rules under the IRA and actions by the FTC would have kept patients from accessing his company’s sickle cell treatment. (Stat News)
Coalition for Health Advances & Research in Massachusetts (CHARM)
MassBio is a steering committee member of the Coalition for Health Advances & Research in Massachusetts (CHARM) that was launched to rally support for locating the headquarters of the newly formed Advanced Research Projects Agency for Health (ARPA-H) in Massachusetts. ARPA-H was created by the Biden Administration to accelerate research aimed at preventing and curing diseases ranging from infectious disease, chronic disease, Alzheimer’s, and cancer. CHARM is composed of organizations representing the wide breadth of industries and sectors that compose the Massachusetts innovation economy, as well as municipal, state, and federal government partners.
The MA Biotech Caucus
The Massachusetts State Legislative Biotech Caucus is a group of state legislators interested in and supportive of the life sciences industry. Caucus meetings may include company site visits, panel discussions on hot topics, or educational programs. By sharing information and resources with the Caucus Co-Chairs, MassBio helps inform the Caucus’ activities and educational opportunities.
Policy Working Group
MassBio convenes a Policy Working Group of member company government affairs leads and key company contacts who meet regularly to discuss and formulate MassBio’s state and federal advocacy strategy.
Inclusion in the Policy Working Group is by invitation only.
Our approach to legislative advocacy is driven by two aligned missions: protecting patient access to existing and future therapies; and ensuring Massachusetts remains the best place in the world for life sciences companies to thrive. State and federal policy priorities are developed by MassBio’s government relations team in close consultation with our member companies through the Policy Working Group and other industry stakeholders.
Massachusetts is the world leader in life sciences innovation. We also lead in healthcare policy and access to high quality healthcare and breakthrough therapies. That’s why it’s critical we educate and inform state legislators as they make decisions that impact our ecosystem. Our state advocacy focuses on issues such as: commercial and Medicaid access and reimbursement, the proper use of health technology assessments (HTAs), co-pay assistance programs, transportation, housing, workforce development, and diversity & inclusion.
MassBio Bills of Interest:
|H1176||An Act relative to promoting comprehensive transparency in the pharmaceutical industry (Summary)||Coppinger|
|S732||An Act relative to promoting comprehensive transparency in the pharmaceutical industry||Cronin|
|H978||An Act relative to promoting healthcare access and affordability for patients (Summary)||Coppinger|
|S612||An Act relative to promoting healthcare access and affordability for patients||Cronin|
- MassBio’s Financial Services Written Testimony on H978 & S612 (5.17.23)
- MassBio’s Health Care Financing Written Testimony (6.13.23)
- Reauthorization of the Life Sciences Initiative
MassBio consistently works to promote a regulatory and legislative environment that enables the life sciences industry to thrive. MassBio has established long-lasting relationships with both lawmakers and regulators in Washington DC and continues to advocate for policies and initiatives on behalf of the industry. Our federal advocacy focuses on a range of issues from: access to reimbursement, paying for value, tax reform, workforce development, immigration, NIH funding, and the regulatory environment.
Inflation Reduction Act (IRA):
Signed into law by President Biden in August 2022, the Inflation Reduction Act (IRA) authorizes the Secretary of the Department of Health and Human Services (HHS) to negotiate prices directly with participating manufacturers for selected drugs that have high total spending and are high expenditure, single source drugs without generic or biosimilar competition.
- IRA Implementations Comment Letter (4.13.23)
- Information Collection Request (ICR) Form for IRA Negotiation Data Elements Comment Letter (5.22.23)
- Part D Redesign Comment Letter (6.1.23)
- Medicaid Drug Rebate Program (MDRP) Proposed Rule Comment Letter (7.24.23)
- Smoothing Guidance Comment Letter (9.19.23)
City of Cambridge:
- Comment letter on proposed ban to new laboratory construction in the City of Cambridge (1.3.23)
- Comment letter on relative to amending the Municipal Code for the City of Cambridge to add a new Chapter, 15.30, titled “Fossil Fuel Free Demonstration,” proposed Ordinance 2023-3, and more specifically the proposed amendment to BEUDO (8.1.23)
City of Boston:
MassBio actively works with policy makers to develop laws and regulations that foster innovation.
Massachusetts State Elected Officials – find your legislator