WASHINGTON (AP) — A plan to give Americans easier access has 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 into drafting the policy, according to six people familiar with the policy development.
The document, which covers some injectable peptides popular within the wellness industry, recently underwent regulatory review at the White House, typically the final step before release.
The peptide effort, led by Kennedy’s Department of Health and Human Services, has faced strong opposition from the FDA’s pharmaceutical staff, who have warned that it could harm the agency’s longstanding mission of keeping unproven health products out of the U.S. market, according to 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 have not undergone the agency’s rigorous review process for safety and effectiveness, according to three of the people.
The people spoke to The Associated Press on 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 necessary for growth, metabolism and healing. Pharmaceutical companies have marketed many of these as drugs, including basic treatments for diabetes and weight loss.
Chemicals subject to the new policy have not undergone this 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 sporting authorities.
Kennedy called himself a “big fan” of peptides and recently described using BPC-157 to treat a muscle injury.
The guidance document being considered by the White House represents a step backwards from HHS’s initial plans, according to two of the people who discussed its development.
Initially, HHS officials wanted the FDA to draft a formal regulation that would add BPC-157 and other peptides to a list of drug substances deemed safe for use by compounding pharmacies, specialty companies that make personalized medications.
But FDA officials warned that the agency’s scientific staff had major safety concerns and would not support regulations deeming them safe. So HHS officials took a different approach that would direct the FDA not to enforce its rules against pharmacies that compound these substances.
Ultimately, FDA staff provided technical assistance in drafting the HHS plan, including safeguards intended to improve safety, such as requiring pharmacies to use peptide ingredients from FDA-regulated factories.
Composition decisions have long been the purview of the FDA, not HHS.
Kennedy has repeatedly said that U.S. compounding pharmacies should be allowed to sell peptides because Americans are turning to “gray market” products imported from China and other countries.
Decisions regarding the regulation of peptides and compounding pharmacies almost always come from the FDA, which has an office dedicated to protecting Americans from dangerous or poor-quality compounded medications.
The issue of compound safety became a major concern 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 become a multi-billion dollar industry, providing personalized medicines to doctors, clinics and hospitals.
It is extremely rare for HHS to take the lead in developing policies regarding the compounds industry, former FDA officials said. However, federal law technically gives HHS authority over virtually all drug regulations, which are then delegated to the FDA.
FDA Warns Americans About Safety Risks of Unproven Peptides
Many Americans using peptides today do not go to a doctor or pharmacy to get injected. Instead, they often order bottles sold by China-based chemical manufacturers online. Peptide sellers often attempt to circumvent U.S. regulations by labeling their products as “research only,” since the FDA does not regulate chemicals intended for research use.
In 2023, the FDA added more a dozen peptidesincluding BPC-157 and TB-500, to its list of substances that should not be mixed due to risks of allergic reactions, kidney damage and tumor growth.
At a July meeting, FDA staff reiterated that more than half a dozen peptides proposed for review remained unproven in terms of safety and effectiveness.
The policy pending at the White House avoids a direct confrontation with FDA staff because it simply directs the FDA not to enforce certain rules.
HHS ultimately included several safety measures suggested by FDA staff, according to two of the people. In addition to sourcing ingredients from FDA-registered facilities, compounders will be asked to collect side effect information for safety analysis and verify the chemical identity of peptides.
These measures are supported by some industry groups, including the Alliance for Pharmacy Compounding, which recently met with White House officials about the proposal.
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