FDA Scientists Opposed Trump-Era Plan to Ease Access to Unproven Peptide Drugs
Internal opposition arose over a policy that would have allowed specialty pharmacies easier access to certain injectable peptides.
Most scientific staff members at the Food and Drug Administration (FDA) opposed a plan during the Trump administration aimed at providing easier access to unproven peptide drugs, according to six individuals familiar with the policy's development. These staff members had limited input in the drafting of the policy.
The proposed policy would have directed the FDA not to take action against specialty pharmacies selling certain widely used peptides. These substances would otherwise be considered illegal drugs as they have not undergone the agency's rigorous safety and effectiveness review.
Some peptides occur naturally in the human body and play roles in growth, metabolism, and healing. Approved by the FDA, several peptides are already marketed as treatments for conditions such as diabetes and weight loss. However, the peptides in question, including BPC-157 and TB-500, have not gone through this vetting process. They are promoted for aiding injury healing and muscle building and are classified as doping substances by international sports organizations.
Robert F. Kennedy Jr., then Secretary of Health and Human Services, had promoted peptides, stating he was a "big fan" and had used BPC-157 for a muscle injury. The Health and Human Services (HHS) department initially sought to have the FDA issue a regulation adding these peptides to a list of drug substances deemed safe for compounding pharmacies. However, FDA officials raised significant safety concerns, leading HHS to shift its approach to directing the FDA not to enforce existing rules against pharmacies compounding these substances.
Despite the opposition, FDA staffers provided technical assistance for drafting the HHS plan, including measures intended to enhance safety, such as requiring pharmacies to source peptide ingredients from FDA-regulated facilities.
Kennedy had argued that U.S. compounding pharmacies should be allowed to sell peptides to prevent Americans from using "gray market" products imported from other countries. Historically, decisions regarding the regulation of peptides and compounding pharmacies have primarily been made by the FDA, which has a dedicated office for overseeing compounded drugs.
The issue of compounding safety gained prominence after a 2012 outbreak of fungal meningitis linked to contaminated injections from a Massachusetts compounding pharmacy. Compounding has since grown into a significant industry.
In 2023, the FDA added over a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded due to potential risks such as allergic reactions, kidney damage, and tumor growth. At a meeting in July, FDA staff reiterated that many peptides under reconsideration had not demonstrated proven safety or effectiveness.
The policy pending at the White House aims to avoid direct conflict with FDA staff by instructing the agency not to enforce certain rules. HHS included safety measures suggested by FDA staff, such as requiring compounders to verify peptide identity and collect side effect data for analysis. These measures have received support from some industry groups, including the Alliance for Pharmacy Compounding.