Most FDA scientists reportedly oppose HHS plan to ease peptide access

Draft guidance would limit enforcement against specialty pharmacies

Most U.S. Food and Drug Administration scientific staff members opposed a Department of Health and Human Services plan to ease access to unproven peptide drugs, according to six people familiar with the policy’s development. The draft guidance covers certain injectable peptides popular within the wellness industry and recently underwent regulatory review at the White House, typically the final step before publication.

The six people said FDA scientific staff had limited input in drafting the policy. According to the people familiar with its development, the effort drew overwhelming pushback from FDA drug staffers, who warned that it could undermine the agency’s longstanding mission of keeping unproven health products off the U.S. market.

The policy would direct the FDA not to take action against specialty pharmacies selling certain widely used peptides, according to three of the people. Those substances otherwise would be considered illegal drugs because they have not gone through the FDA’s rigorous review process for safety and effectiveness. Specialty pharmacies make customized medications.

The reviewed document represents a step back from HHS’s original plans, according to two of the people who discussed its development. Initially, HHS officials wanted the FDA to draft an official regulation adding BPC-157 and other peptides to a list of drug substances deemed safe for compounding pharmacies. FDA officials warned that the agency’s scientific staff had major safety concerns and would not support a regulation deeming the peptides safe, so HHS officials shifted to the non-enforcement approach.

FDA staff ultimately provided technical assistance in drafting the HHS plan, including guardrails intended to improve safety, such as requiring pharmacies to use peptide ingredients from FDA-regulated factories. According to two of the people, HHS also included measures requiring compounders to collect information on side effects for safety analysis and verify the chemical identity of peptides. The Alliance for Pharmacy Compounding, an industry group, recently met with White House officials about the proposal and supports the measures.

The chemicals subject to the policy include BPC-157 and TB-500, which are promoted to help heal injuries and build muscle. International sports authorities consider both to be doping substances. Some peptides occur naturally in the human body, where they trigger hormones needed for growth, metabolism and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss.

Decisions over compounding have long rested with the FDA, which has an office dedicated to protecting Americans from unsafe or poor-quality compounded drugs. Former FDA officials said it would be extremely rare for HHS to take the lead in drafting policies over the compounding industry. Federal law technically gives HHS authority over essentially all drug regulations, which are then delegated to the FDA.

The issue of compounding safety became a greater focus for the FDA after a deadly outbreak of fungal meningitis in 2012 was linked to contaminated injections from a Massachusetts compounding pharmacy. Once a niche business, compounding has grown into a multibillion-dollar industry that provides customized medications to doctors, clinics and hospitals.

Health Secretary Robert F. Kennedy Jr. has said repeatedly that U.S. compounding pharmacies must be allowed to sell peptides because Americans are turning to “gray market” products imported from China and other countries. Kennedy has called himself a “big fan” of peptides and recently described using BPC-157 to treat a muscle injury.

Many Americans using peptides do not deal with a doctor or pharmacy to get the injections. Instead, they often order vials online from chemical manufacturers based in China. Peptide sellers often try to skirt U.S. regulations by labeling their products “for research use only,” because the FDA does not regulate research chemicals.

In 2023, the FDA added more than a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded because of risks of allergic reactions, kidney damage and tumor growth. At a meeting in July, FDA staff reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness.

The pending guidance avoids a direct confrontation with FDA staff because it directs non-enforcement rather than deeming the peptides safe. The White House regulatory review is typically the final step before publication. An HHS spokesperson did not immediately respond to requests for comment.