PEAT Act of 2026

The PEAT Act of 2026 amends federal regulations to clarify how certain biologic drugs are classified for approval purposes. Specifically, it prevents the Food and Drug Administration from denying approval to a biologic product simply because it contains a protein that does not have a clinical effect. This change ensures that the presence of inactive proteins does not automatically disqualify a drug from being treated as a biological product. The legislation directly impacts pharmaceutical companies developing complex biologics and the regulatory review process for these medicines. By removing this specific barrier, the bill aims to streamline the path to market for drugs that include non-active protein components.