HR 8630
PEAT Act of 2026
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Bill overview
The PEAT Act of 2026 aims to clarify how biologics are defined for treatment purposes. Specifically, it prohibits treating a biologic as a ‘biological product’ simply because it contains a protein that isn't actively involved in its therapeutic effect. This change is intended to ensure access to treatments based on the overall function of the biologic, rather than isolated inactive components. The bill modifies a section of the Public Health Service Act to achieve this outcome.
Key provisions
- Prohibits classifying biologics as ‘biological products’ based solely on inactive proteins.
- Modifies Section 351(i)(1) of the Public Health Service Act.
- Addresses clinically inactive components within biologics.
- Clarifies the definition of ‘biological product’ in the context of biologic treatments.
Who is affected
- Patients receiving biologic treatments
- Pharmaceutical companies developing biologics
- Healthcare providers prescribing biologics
- The Department of Health and Human Services
Notable changes
- Changes the definition of ‘biological product’ to exclude biologics with clinically inactive proteins.
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119th CONGRESS — 2d Session
H. R. 8630
IN THE HOUSE OF REPRESENTATIVES
A BILL
To amend the Public Health Service Act to prohibit treatment of a biologic as a biological product based solely on the presence of a protein that is a clinically inactive component in such biologic, and for other purposes.
This Act may be cited as the Protecting Equal Access to Thyroid Act of 2026 PEAT Act of 2026
or the
.
by striking The term
and inserting the following:
by adding at the end the following:
protein ,and inserting
protein,.