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HD 1476

An Act protecting patient safety regarding non-FDA approved drugs

194th Legislature (2025-2026) Introduced by Patrick Kearney and 1 co-sponsor

Massachusetts bill restricts non-FDA approved drug use in healthcare, requiring provider documentation and adverse event reporting to strengthen patient safety oversight.

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Bill Summary · HD 1476

Legislative bill overview

HD 1476 restricts the use of non-FDA approved drugs in Massachusetts healthcare settings, requiring additional oversight and safety protocols before such medications can be administered to patients. The bill establishes requirements for healthcare providers to document justification when prescribing unapproved drugs and mandates reporting of adverse events to state health authorities.

Why is this important

Patients may currently receive medications that lack FDA approval through legitimate pathways (like compassionate use or right-to-try programs), but without standardized safety monitoring. This bill creates accountability mechanisms to track outcomes and protect vulnerable patients from potentially ineffective or harmful treatments while still preserving access to experimental options when appropriate.

Potential points of contention

  • Right-to-try limitations: Patient advocates may argue the bill creates bureaucratic barriers to terminally ill patients accessing experimental treatments they believe could help them, contradicting the spirit of existing federal right-to-try laws
  • Healthcare provider burden: Doctors may contend that extensive documentation requirements and reporting obligations add administrative costs and liability exposure without meaningfully improving safety
  • Definition ambiguity: The bill's scope regarding which drugs qualify as "non-FDA approved" could be unclear, potentially catching imported medications, compounded drugs, or off-label uses in ways legislators didn't intend

Compiled from official sources — confirm details with the bill’s official record.

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