FDA scientists caution against easing peptide drug regulations for compounding pharmacies

The U.S. Food and Drug Administration (FDA) is assembling a new advisory committee to consider whether compounding pharmacies should be permitted to manufacture peptide drugs. In a briefing released on Monday, FDA scientists with industry experience recommended opposing any regulatory relaxation for seven specific peptide ingredients that are being explored for use in ulcerative colitis, insomnia and obesity. The scientists argued that the current evidence does not sufficiently demonstrate the efficacy and safety of these peptides, and therefore a cautious approach is warranted before expanding their accessibility.