FDA Policy/General

Advocacy Group Files Petition Urging FDA to Block Peptide Compounding

The Partnership for Safe Medicines (PSM) has filed a citizen petition urging FDA to ban compounding of unapproved peptides and to disregard the advisory committee vote that recommended allowing them. The advocacy group contends the committee was constituted in violation of the Federal Advisory Committee Act and the Ethics in Government Act, federal laws that govern conflicts of interest in agency advisory proceedings.

At an FDA Pharmacy Compounding Advisory Committee (PCAC) meeting in July, the agency’s scientists recommended against bulk compounding of seven substances under consideration – BPC-157, KPV, TB-500, MOTS-c, emideltide, semax, and epitalon. The Committee, whose newly appointed members included some with financial ties to the peptide industry, voted in favor of allowing six out of the seven unapproved substances to be compounded (see earlier story).

“We are deeply concerned that legitimizing untested and poorly defined substances knowingly puts Americans at risk,” the group said. "FDA scientists reviewed these substances and found no adequate characterization, extremely limited safety data, and no meaningful human evidence. Legitimizing these compounds doesn't make them safer. It just makes them easier to sell."

The petition asks FDA to take two actions:

block compounding of these peptides by any route
disregard the PCAC meeting as a basis for future rulemaking

“PSM’s petition is grounded in the concern that patients are being exposed to potentially dangerous substances, and the regulatory and enforcement process designed to protect them is not functioning as intended,” the advocacy group said in a statement. “It argued that the scientific record and PCAC’s conflicts of interest are grounds to disregard the committee’s vote.”

The petition coincides with recent movement by the Trump administration to advance an interim plan to allow compounding pharmacies to produce certain unapproved peptides. HHS 10/15 submitted an "interim access policy" for peptides to the White House Office of Management and Budget (see earlier story).

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Petition Seeks Immune Monitoring Requirements for Vertex's Povetacicept

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