Fast-growing peptide business faces big week at FDA

Lizzy leads STAT’s FDA coverage. Her story explores the relationship between politics and science at the FDA, its influence on industry, and the agency’s ability to protect and promote public health. Sensitive information can be sent on Signal at lizzylaw.53.

A Food and Drug Administration advisory committee is scheduled to meet Thursday and Friday to discuss changes to make peptides more accessible as more Americans experiment with synthetic peptides despite warnings about unproven benefits and potential risks.

At issue is whether compounding pharmacies will be allowed to manufacture seven types of peptides that are currently designated as unsafe to manufacture. The panel discussion is expected to be unusual in many ways.

First, many of the committee’s newly appointed members hold what critics (including FDA staff) claim are conflicts of interest. The panel’s roster includes several doctors who prescribe peptides to their patients, as well as pharmacist and Tennessee state senator Bobby Hershberger, whose mother, U.S. Representative Diana Hershberger (R-Tenn.), has advocated for loosening peptide regulations. Many of these panelists were selected by the Department of Health and Human Services, FDA officials previously told STAT.

STAT+ exclusive story