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The proposal would change how the government classifies certain medications made from living cells or organisms, preventing regulators from treating a drug as a biologic product just because it contains a protein that doesn't actually affect how the medicine works. This could affect pharmaceutical companies by potentially allowing some drugs to be classified under simpler approval pathways rather than the more complex biologic drug process. The change aims to streamline drug development and approval for medications where inactive proteins are present but not medically relevant.
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[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 8630 Introduced in House (IH)] <DOC> 119th CONGRESS 2d Session H. R. 8630 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. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES April 30, 2026 Mr. Rulli (for himself and Mrs. Harshbarger) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ 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. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Protecting Equal Access to Thyroid Act of 2026'' or the ``PEAT Act of 2026''. SEC. 2. PROHIBITION WITH RESPECT TO TREATMENT OF PROTEINS IN BIOLOGICS. (a) In General.--Section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is amended-- (1) by striking ``The term'' and inserting the following: ``(A) The term''; and (2) by adding at the end the following: ``(B) A biologic described in subparagraph (A) may not be treated as a biological product based solely on the presence of a protein that is a clinically inactive component in such biologic.''. (b) Technical Correction.--Section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is amended in subparagraph (A), as designated by subsection (a)(1), by striking ``protein ,'' and inserting ``protein,''. <all>
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