Former FDA Official Warns Unapproved Peptides Undermine Public Health, R&D Investment
Life sciences and biotech companies developing peptide therapies must track evolving FDA oversight priorities, as widespread unapproved peptide products threaten public health and deter investment in required clinical trials for approved therapies.
Former FDA Deputy Commissioner for Global Regulatory Operations and Policy and Arnold & Porter Life Sciences & Healthcare Regulatory partner Howard Sklamberg recently discussed FDA oversight gaps for peptide products on NPR’s Short Wave. He noted many peptides marketed for anti-aging, performance enhancement and recovery lack the rigorous clinical testing required for FDA approval. Sklamberg warned the broad availability of unapproved compounded peptides creates dual risks: it discourages private investment in costly clinical trials for approved peptide therapies, and exposes consumers to unvetted public health harms. Life sciences firms with active peptide R&D pipelines should monitor potential FDA enforcement actions targeting unapproved products, and assess how regulatory shifts could impact their investment timelines and product approval strategies.