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 May 6, 2024 — Legislative Update
Federal
The Federal Trade Commission is challenging 300+ patents filed with the FDA to protect market exclusivity for top-selling drugs. (BioPharma Drive) | Related: FTC wants more information on Novo-Catalent deal in antitrust review. (Endpoints)
Healthcare and drug industry groups on Wednesday urged a U.S. appeals court to revive their challenge to the IRA’s drug negotiation program, even as a separate challenge lost in NJ court. (Reuters)
The Senate Finance Committee introduced bipartisan legislation Friday aimed at preventing and reducing generic drug shortages by leveraging Medicare and Medicaid programs. (The Hill)
A bipartisan group of senators introduced a bill on Thursday that calls for $275 million over five years to support federal menopause research and awareness efforts. (Endpoints)
State
House health care bill features lessons learned from the Steward Health Care crisis, major changes to how state regulators work to contain healthcare spending, and new tools to deal with facility expansions and closures. (State House News)
Week of April 29, 2024 — Legislative Update
At the MassBio State of Possible Conference, Governor Healey said her proposed Life Sciences 3.0 invests in job growth, health outcomes, and regionalization. Congressman Jake Auchincloss called for the federal government to put forward a Chips 2.0, this time focused on biomanufacturing rather than semiconductors, to compete internationally in this sector. (Boston Business Journal)
Federal
The Federal Trade Commission approved a far-reaching noncompete ban Tuesday that could force sweeping changes across the health care industry. (Stat)
A House committee next month plans to mark up legislation that would restrict U.S. biotechs from doing business with a Chinese company that makes key drug ingredients. (Stat)
The FDA’s Center for Biologics Evaluation and Research is planning to release some crucial guidance soon for CRISPR and gene therapy developers. (Endpoints)
How biotech can ‘expand the state of possible’: BIO President & CEO John F. Crowley in Boston (Good Day BIO)
Patient advocates shred Department of Health and Human Services Secretary Xavier Becerra’s copay accumulator comments during House hearing (Fierce Healthcare)
According to CMS, a federal rule aiming to make reimbursement for breakthrough devices easier is slated for early summer (Stat News)
Government Accountability Office finds that states favor broad authority over PBMs (Endpoints)
Pharmacy benefit managers, not Big Pharma, responsible for high drug prices (Business Journal)
State
Potential contours of health care landscape reform legislation are coming into clearer view (State House News Service)
Week of April 15, 2024 — Legislative Update
Federal
The Centers for Medicare and Medicaid Services (CMS) said Wednesday that it will increase reimbursements for two newly approved sickle cell gene therapies. (Endpoints)
A RAND Corporation researcher writes in the Boston Globe that while the FDA is doing its part to fast-track new treatments, insurers are standing in the way of affordable access. (Boston Globe)
Novartis, Sanofi, and PhRMA are asking the FDA to streamline its processes for working with sponsors on complex and innovative designs for clinical trials. (STAT)
State
A total of 1495 amendments to the House budget were filed by the Friday deadline. With the Passover holiday on April 22-23, House debate will not start until Wednesday, April 24. | Mass. House proposes budget in time of ‘choppy waters’. (WBUR)
Health Policy Commission sets the 2025 cost growth benchmark at 3.6%, declining to lower the spending target after pressure from specific stakeholders. (Boston Business Journal)
Week of April 8, 2024 — Legislative Update
Federal
The authors of a Stat First Opinion column write that the latest weight loss drugs can save lives and “literally remake American health,” but a political conversation about price controls could derail innovation. (Stat)
State
Senate Ways & Means Chairman Michael Rodrigues says he wants to "take for-profit, equity-based companies out of the health care system.” (Boston Business Journal)
According to House Speaker Ron Mariano’s office, the House budget to be released on Wednesday will include record investment in the state’s transportation systems including the MBTA. (Boston Herald)
Week of April 1, 2024 — Legislative Update
Federal
A new report finds that 85% of disproportionate share (DSH) hospitals earn more in 340B profit than they spend on charity care—another sign of the need to reform this program intended to support vulnerable patients, according to BIO. (Good Day BIO)
The US intelligence officials told Congress that WuXi transferred IP to Chinese authorities — report. (Endpoints)
State
May 1 Deadline For $10 Mil In Maternal Health Grants (statehousenews.com)
Healey reiterates mifepristone support in wake of Supreme Court arguments (Boston.com)
Week of March 25, 2024 — Legislative Update
Federal
Biden and Trump have also made clear their policy agendas aimed at reducing the high cost of prescription drugs and the power of Big Pharma. (BioSpace)
Legislation targeting Chinese CDMOs and genomics companies, if passed in its current form, will deal a massive blow to biotech companies. (BioCentury)
The U.S. House passes the Preventive Health Savings Act, which would provide a framework for the Congressional Budget Office (CBO) to evaluate the long-term budget impacts of preventive health care legislation. (Press Release | Flagship Letter of Support)
A healthcare package that would have advanced pharmacy benefit manager reforms and other healthcare priorities was not in the final appropriations bill passed by Congress and signed by President Biden. (Modern Healthcare)
Week of March 18, 2024 — Legislative Update
Federal
Leaders on the Senate Finance Committee are making a push to pass reforms to pharmacy benefit managers as Congress inches up to a March 22 deadline to clear the next round of appropriations bills. (Endpoints)
State
Those who testified at Thursday’s cost growth benchmark hearing were all passionate in their point that the price of health care is too high — though they had different opinions on who or what was to blame. (State House News)
Massachusetts healthcare organizations far exceeded the state's spending targets as a new report shows that Covid-19 once again drove more medical spending in 2022. (Boston Business Journal)
Week of March 11, 2024 — Legislative Update
Federal
Sen. Ed Markey signed onto a letter from Sen. Cassidy expressing concerns to the NIH regarding President Biden's proposal to allow agencies to seize drug patents under the Bayh-Dole Act. (help.senate.gov)
Biden proposes expanding Medicare drug price negotiation in State of the Union (Stat) | Opinion: “Biden’s SOTU highlights pharma’s biggest political problem: It is terrifyingly, awfully alone” (Stat)
Senate panel advances bill to ban some Chinese biotechs, with Sen. Rand Paul taking up industry’s cause (Stat)
House passes bill to help biotech startups build capital (bio.news)
State
Gov. Healey visits Hopkinton business to tout investment in state's life sciences industry (MetroWest Daily News)
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.
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.
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.