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.

Referred to the House Committee on Energy and Commerce.

2026-04-30

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.