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.
MassBio regularly 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 July 8, 2024 — Legislative Update
Federal
President Joe Biden and Senate Health Committee Chairman Bernie Sanders pen an opinion piece challenging the pharmaceutical industry and drug pricing in America (USA Today).
Senator Dick Durbin (D-Il) and FTC Chairwoman Lina Khan author an opinion piece calling for a further "crackdown" on pharmaceutical industry patent strategies (STAT).
A federal judge ruled against Boehringer Ingelheim’s challenge to the new Medicare drug price negotiation program (STAT).
State
Massachusetts Senate Chair of Elder Affairs Pat Jehlen remains confident that a final long-term care bill will be presented to the Governor before the July 31st session deadline (State House News).
A final salary and wage transparency bill is among the pieces of legislation awaiting approval before clocks run out on July 31st (Boston Globe).
Week of July 1, 2024 — Legislative Update
Federal
In a 6-3 decision, the Supreme Court overruled the longstanding Chevron doctrine last week, weakening federal agencies' longtime authority to interpret federal law (STAT) which legal scholars warn could quickly disrupt FDA operations (Endpoints) and mean further headaches for the drug industry (More STAT).
The House Ways & Means Committee unveiled a proposal on Wednesday to offer a limited pathway for seniors to get their weight loss drugs like Wegovy and Zepbound covered by Medicare, primarily ensuring people taking weight loss drugs are not discontinued when they enter the Medicare program by turning 65 (STAT).
HHS announced 64 drugs up for Medicare inflation rebates next year following the IRA's requirement for Medicare Part B rebates on drugs with prices rising faster than inflation (Endpoints).
State
The Massachusetts House passed its iteration of the statewide economic development bond bill last week, mirroring Governor Healey's $1 billion investment into the life sciences industry in the Commonwealth over the next decade (State House News Service).
Week of June 24, 2024 — Legislative Update
Federal
The powerful House Ways and Means Committee is weighing reforms to two major health care bills this week that would expand Medicare coverage of cancer screening tests and recently popularized weight loss treatments (STAT).
The federal Food and Drug Administration approved broader use of Sarepta Duchenne gene therapy, Elevidys, last week (Biopharma Dive).
Rep. Cathy McMorris Rodgers (R-Wash. chair of the House Committee on Energy and Commerce) and Rep. Robert B. Aderholt (R-Ala. chair of the House Appropriations Labor, Health & Human Services, and Education Subcommittee) introduce sweeping plans to reform the National Institutes of Health via director term limits, infectious disease research restrictions, and enhanced transparency of grant reporting (STAT).
State
The Massachusetts House passed a sweeping maternal health bill last week, checking a key health equity measure off Speaker Mariano's list this session by allowing for certified professional midwives and lactation consultant services to be covered by MassHealth and removing certain regulatory barriers to allow more non-hospital birthing centers in the state (State House News Service)
Week of June 17, 2024 — Legislative Update
Federal
Congress has until the end of September to reauthorize a voucher program intended to encourage new drug development for rare pediatric diseases. (Endpoints News)
Following repeat threats of a subpoena from Senator Bernie Sanders (I-VT), Novo Nordisk CEO agrees to testify live before the Senate health committee in early September to discuss US pricing structures for Novo's diabetes treatment, Ozempic, and its weight loss drug, Wegovy. (STAT)
The Biosecure Act, banning US biotechs from engaging in business with certain Chinese companies, failed to make it into the National Defense Authorization Act for Fiscal Year 2025 last week, as previously speculated. (Endpoints News)
The Congressional Budget Office last week estimated the Affordable Prescriptions for Patients Act of 2023 could save the federal government over $3 billion over the next ten years by targeting pharmaceutical patents and further regulating "patent hopping" practices. (Endpoints News)
State
The Massachusetts House passed legislation addressing the ongoing opioid crisis by mandating insurance coverage of overdose reversal drugs, enhancing the licensure processes for recovery coaches, and introducing legal protections for drug-testing kits to limit liability for users and harm reduction workers. (State House News)
Which bills have passed which Chamber, what's been conferenced, and what's left on the docket? Check out the State House News Service's End of Session Bill Tracker to follow along as we approach the July 31 session deadline.
Week of June 10, 2024 — Legislative Update
Federal
Sen. Elizabeth Warren and Rep. Lloyd Doggett (Texas) wrote to the Department of Commerce urging the finalization of its pharmaceutical patent seizure policy, first proposed by the Biden administration in December as an update to the federal government's "march-in rights." (Reuters)
Manufacturers push back against Maryland's Prescription Drug Affordability Board as it conducts affordability studies on six drugs. (Endpoints)
The National Institutes of Health is investing $30 million in a first-of-its-kind national primary care research network pilot to allow a small number of primary care sites to participate in a range of clinical trials in hopes of increasing clinical trial diversity. (STAT)
State
The Joint Committee on Economic Development and Emerging Technologies favorably reported a minimally redrafted version of Governor Healey's economic development bond bill, retaining a $1 billion investment in the life sciences over the next decade. (State House News)
Tech trade group issues new recommendations on how the state can best apply artificial intelligence (AI) to boost its life sciences and healthcare industries, with input from local life sciences leadership including Takeda and Biogen. (BBJ)
International
A panel at BIO International in San Diego discussed the pros and cons of recent biotech regulatory revisions made by the European Commission. (Contract Pharma)
Week of June 3, 2024 — Legislative Update
Federal
The national trade group representing laboratory companies and test manufacturers is suing the FDA to prevent increased oversight of lab-developed tests, claiming the agency would be overstepping its authority. (Fierce Biotech – May 31)
The FDAhas initiated a planned reorganization of its worldwide inspection operations with the official restructuring scheduled to begin in October 2024. (Endpoints News – May 30)
House Energy and Commerce subcommittee on health questioned FDA directors on generic drug manufacturing, clinical trial diversity, and the agency's new rule on lab-developed tests. (Endpoints News – May 22)
State
House Democrats unveiled their redraft of Governor Healey's housing bond bill, containing $6.2 billion in borrowing and tax credits and policy reforms designed to spur housing production and help address high housing costs in Massachusetts. (State House News Service)
The Joint Committee on Financial Services favorably reported legislation expanding access to biomarker testing by mandating state-regulated insurance coverage; the bill is now before the Joint Committee on Health Care Financing for further review. (State House News Service)
Week of May 27, 2024 — Legislative Update
Federal
A federal appeals court sided with pharmaceutical manufacturers on Tuesday, ruling that drugmakers are not prohibited from restricting the contractual distribution of 340B discount drugs to an unlimited number of contract pharmacies (Endpoints News).
Executives from Optum, CVS Caremark, and Express Scripts/Cigna - the nation's leading pharmacy benefit manager companies - have been invited to testify before the House Committee on Oversight and Accountability next month, further signaling the Committee's interest in regulating PBM practices following an investigation initiated by the panel in April (STAT).
Senate Judiciary Committee members from both sides of the aisle agreed on the need for drug patent reform this week, including a push for legislation to increase interagency coordination between the US Patent and Trademark Office and the FDA (Endpoints News).
State
Patient-centered legislation mandating insurance coverage of comprehensive, medically necessary biomarker testing cleared the Financial Services Committee this week and is likely headed to the Joint Committee on Health Care Financing for further review (State House News Service).
Massachusetts Senate passes $58 billion budget late Thursday night, adding $89.6 million in spending for local priorities and statewide initiatives, including free community college across the state. (WCVB)
Week of May 20, 2024 — Legislative Update
Federal
The House Oversight Committee last week advanced the BIOSECURE Act, which would force biopharma companies to cut ties with WuXiAppTec and other Chinese biotech suppliers by 2032, with bipartisan support. (Endpoints News)
A new IQVIA report details how the size of the federal 340B drug discount program has tripled since 2018 and could even double again. (Endpoints News)
White House issues plan to raise tariffs on $18 billion worth of imported goods from China, including syringes and surgical gloves, pitching it as a way to protect domestic manufacturing from "unfair trade practices." (STAT)
CEO of Cambridge-based Anthos Therapeutics CEO pens BBJ op/ed celebrating the public-private investment partnership that Bayh-Dole created and warning against using “march-in” in the name of price controls. (Boston Business Journal)
State
Massachusetts House of Representatives votes to approve major hospital sector oversight and reform bill intended to avert another Steward Health Care crisis, boost state oversight of facility closures and mergers, and increase funding to hospitals that serve a disproportionately high volumes of low-income patients. (State House News)
Week of May 13, 2024 — Legislative Update
Federal
A new version of the BIOSECURE Act, restricting US business with certain Chinese biotechnology companies would give US companies until 2032 to end work with the firms, extending the amount of time to find new partners. (Reuters and Fierce Pharma)
A new bill being considered by the House Ways and Means Committee to extend telehealth flexibilities for Medicare enrollees for another two years looks to use pharmacy benefit manager reform to pay for it (STAT) by delinking their compensation from the list price of a drug. (Endpoints News)
Industry groups PhRMA and BIO raise concerns about the Centers for Medicare & Medicaid Services' proposed changes to its Medicare negotiation guidance, some of which would affect how the next round of drug prices is negotiated under the Inflation Reduction Act. (Endpoints News)
Senators Warren, Sanders, and Merkley pen a letter to the US Chamber of Commerce, accusing its coalition of attempting to stymie national drug pricing initiatives by challenging a White House proposal to use "march-in-rights.” (Endpoints News)
State
A pair of lawmakers launched a Life Sciences Caucus on Beacon Hill last week. (State House News Service)
Hallmark proposals in Healey's economic development bond bill calling for reauthorizing the life sciences initiative received a public hearing before the Joint Committee on Economic Development and Emerging Technologies in Boston on May 7th. (State House News Service)
The Massachusetts State Legislative Life Sciences 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.
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.
Read MassBio’s 2024 Policy Leadership Breakfast Program Book
State Priorities
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.
Reauthorization of the Life Sciences Initiative – Learn More
Federal Priorities
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.