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Peptide Drugs

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FDA weighs 'enforcement discretion' policy allowing sale of unproven peptide drugs

The FDA has submitted an 'Interim Access Policy' on peptide drugs to the White House for review, according to people familiar with the matter cited by the Associated Press. The policy would reportedly let the agency decline to enforce existing restrictions on certain peptides, reassuring compounding pharmacies that they won't face enforcement action if they begin producing them. This comes as FDA scientists are re-reviewing a dozen peptide drugs previously found in 2023 to lack sufficient safety and efficacy data.