FDA scientists opposed the Trump administration's effort to ease peptides access

WASHINGTON — A plan to give Americans easier access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr. was opposed by most Food and Drug Administration scientific staff members, who had limited input in drafting the policy, according to six people familiar with the policy’s development.

The document, which covers certain injectable peptides popular within the wellness industry, recently underwent regulatory review at the White House, typically the final step before publication.

The effort on peptides, driven by Kennedy’s Department of Health and Human Services, faced overwhelming pushback among FDA drug staffers who warned it could undermine the agency’s longstanding mission of keeping unproven health products off the U.S. market, according to the people familiar with its development.

The policy 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, according to three of the people.

The people spoke to The Associated Press on the condition of anonymity to discuss confidential government deliberations. An HHS spokesperson did not immediately respond to requests for comment.

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.

The chemicals subject to the new policy haven’t gone through that rigorous vetting process. They include BPC-157 and TB-500, which are promoted to help heal injuries and build muscle. Both are considered doping substances by international sports authorities.

Kennedy has called himself a “big fan” of peptides and recently described using BPC-157 to treat a muscle injury.

The guidance document reviewed by the White House represents a step back from HHS’ original plans, according to two of the people who discussed its development.

Initially, HHS officials wanted the FDA to draft an official regulation that would add BPC-157 and other peptides to a list of drug substances deemed safe for use by compounding pharmacies, specialty businesses that make customized medications.

But FDA officials warned that the agency’s scientific staffers had major safety concerns and wouldn’t support a regulation deeming them safe. So HHS officials moved to a different approach that would direct the FDA not to enforce its rules against pharmacies that compound the substances.

Ultimately, 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.

Kennedy 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.

Decisions about regulating peptides and compounding pharmacies have almost always come from the FDA, which has an office dedicated to protecting Americans from unsafe or poor-quality compounded drugs.

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, providing customized medications to doctors, clinics, and hospitals.

It’s extremely rare that HHS would take the lead in drafting policies over the compounding industry, former FDA officials have said. However, federal law technically gives HHS authority over essentially all drug regulations, which are then delegated to the FDA.

Many Americans using peptides today don’t deal with a doctor or a pharmacy to get the injections. Instead, they often order vials online sold by chemical manufacturers based in China. Peptide sellers often try to skirt U.S. regulations by labeling their products as “for research use only,” since the FDA doesn’t 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 due to risks of allergic reactions, kidney damage, and tumor growth.

At a meeting in July, FDA staffers reiterated that more than half a 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 staffers because it only directs the FDA not to enforce certain rules.

HHS ultimately included several safety measures suggested by FDA staffers, according to two of the people. Besides sourcing ingredients from FDA-registered facilities, compounders will be directed to collect information on side effects for safety analysis and verify the chemical identity of peptides.

Those measures are supported by some industry groups, including the Alliance for Pharmacy Compounding, which recently met with White House officials about the proposal.