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.
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Summary
Based on the bill's title, this measure would amend the Public Health Service Act to change how certain biologics are classified for regulatory purposes. Specifically, it would prohibit the FDA from treating a biologic as a biological product solely because it contains a protein that is clinically inactive (i.e., does not contribute to the drug's therapeutic effect). The bill's exact scope and mechanism cannot be determined from the title alone.
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