Fast-growing peptide business faces crucial week at the FDA

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53.

As more Americans experiment with synthetic peptides despite warnings about their unproven benefits and potential risks, an advisory panel to the Food and Drug Administration will meet on Thursday and Friday to discuss changes that could make peptides more accessible. 

At issue is whether to allow compounding pharmacies to manufacture seven peptides that are currently designated as unsafe for them to make. The panel discussion is expected to be unusual in more ways than one. 

First, many of the newly appointed members on the panel hold what critics (including FDA staff) say are conflicts of interest. The panel roster includes several physicians who prescribe peptides to patients as well as pharmacist and Tennessee state Sen. Bobby Harshbarger, whose mother, U.S. Rep. Diana Harshbarger (R-Tenn.) has advocated for looser peptide regulations. Many of these panelists were selected by the Health and Human Services Department, FDA officials previously told STAT.