By Salma El-Sakka
Food and Drug Administration scientific staff members opposed an effort by the Trump administration to loosen rules on unproven peptide drugs, a push driven by Health Secretary Robert F. Kennedy Jr., according to six people familiar with the policy's development.
Internal Opposition and Safety Concerns
Most FDA drug staffers warned the policy could undermine the agency's longstanding mission of keeping unproven health products off the U.S. market. The plan would direct the FDA not to take action against specialty pharmacies that sell certain widely used peptides — substances that would otherwise be considered illegal drugs because they haven't gone through the agency's rigorous review process for safety and effectiveness.
Policy Development and HHS Role
The guidance document recently underwent regulatory review at the White House, typically the final step before publication. Initially, HHS officials wanted the FDA to draft an official regulation adding peptides such as BPC-157 and TB-500 to a list of drug substances deemed safe for use by compounding pharmacies. FDA officials warned that scientific staff had major safety concerns and would not support such a regulation, so HHS shifted to a non-enforcement approach. FDA staffers 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, collect side-effect data, and verify the chemical identity of peptides.
Compounding Regulation History
Decisions over compounding have long rested with the FDA, not HHS. The issue of compounding safety became a greater focus for the FDA after a deadly 2012 fungal meningitis outbreak linked to contaminated injections from a Massachusetts compounding pharmacy. Once a niche business, compounding has grown into a multibillion-dollar industry. It is extremely rare for HHS to take the lead in drafting policies over the space, former FDA officials said, though federal law technically gives HHS authority over all drug regulations, which are then delegated to the FDA.
FDA Warnings on Unproven Peptides
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 due to risks of allergic reactions, kidney damage, and tumor growth. At a meeting in July, FDA staffers reiterated that more than a half-dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness. The policy pending at the White House avoids a direct confrontation with FDA staff because it only directs the FDA not to enforce certain rules.
Industry Response
The safety measures included in the plan are supported by some industry groups, including the Alliance for Pharmacy Compounding, which recently met with White House officials about the proposal.
