A Closer Look at FDA's Next Steps Following Advisory Committee's Recommendation to Legalize Compounding for Wellness Peptides

Healthcare & Life Sciences Team Co-Leader Michael Werner was quoted in The Capitol Forum article examining the U.S. Food and Drug Administration's (FDA) potential path forward after an advisory committee recommended allowing compounding pharmacies to work with six non-FDA-approved wellness peptides. The article analyzed the regulatory and legal hurdles the agency may face as it considers rulemaking to add the substances to its 503A bulks list, including potential challenges under the Administrative Procedure Act (APA). Michael noted that any effort to move forward with peptide compounding may invite legal scrutiny, particularly regarding the scientific basis for the agency's decision.

"I think the regulatory environment is going to be fluid for quite some time," he said. "If FDA decides to move forward, there'll be a regulatory process. But I would bet that a lot of the comments they get from the public are going to be, 'Make these available.'"

READ: A Closer Look at FDA's Next Steps Following Advisory Committee's Recommendation to Legalize Compounding for Wellness Peptides (Subscription required)

Michael previously published a Holland & Knight alert about the advisory committee's recommendation, along with guidance on entering the wellness and peptide industry in light of these developments.