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 22, 2024 — Legislative Update
Federal
The FDA will launch a rare disease center to unify its policies and find new ways to evaluate drugs that can pose a regulatory dilemma (Endpoints News).
Vermont Attorney General files lawsuit against PBMs saying they are behind an illegal effort to drive up drug costs in the state (Endpoints News).
State
The House filed a version of the Senate’s prescription drug bill, striking a balance between reasonable market oversight (including licensing and regulating PBMs), and enhanced patient access (State House News Service). Debate is expected tomorrow. Read MassBio’s statement.
Lawmakers are negotiating a major economic development bill that includes reauthorizing the state's longstanding life sciences initiative (State House News Service).
What they’re saying: "So the one thing that we cannot do -- absolutely, positively cannot do -- is allow them to steal what we have and to bring it to their state. We need to make the investments that the House has proposed in order to keep them here and to make sure, as a lot of people have said, that we lengthen the lead that we have in the area and not sit on our laurels and let other people steal from us, compete with us, or do anything that diminishes what we have here in Massachusetts." - Rep. Ann-Margaret Ferrante (D-Gloucester)
Week of July 15, 2024 — Legislative Update
Federal
The Federal Trade Commission said pharmacy benefits manager (PBM) practices "warrant further scrutiny and potential regulation," after issuing a scathing 73-page report on the industry last week (Endpoints) and plans to sue the three largest PBMs in the country over said pricing practices (Biopharma Dive and STAT).
The Senate unanimously passed the bipartisan Affordable Prescriptions for Patients Act on July 11th, seeking to fight "patent thicketing," by limiting the number of patents drugmakers can assert on individual biological products (Fierce Pharma).
House Speaker Mike Johnson pledged a vote on the Biosecure Act this year, legislation aimed at stemming information sharing and data transfer between companies that receive federal dollars and Chinese biotech contractors (Endpoints).
State
On Monday morning, the Senate Ways and Means Committee teed up a 115-page redrafted market oversight bill combining reporting requirements, noncompliance penalties and private equity scrutiny with a series of changes aimed at prescription drug spending and pharmacy benefit managers with an amendment deadline of 3PM Tuesday and debate on Thursday (State House News).
The Massachusetts Senate last week passed an economic development bill that cut back on life sciences industry investments proposed by Governor Healey and the House of Representatives, despite criticism from the state's biotech trade association (Boston Business Journal).
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)
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.