FDA Scientists Opposed Trump Administration Push to Ease Access to Unproven Peptides

Most scientific staff at the Food and Drug Administration opposed a plan to make unproven peptide drugs easier to obtain, a policy favored by Health Secretary Robert F. Kennedy Jr., according to six people familiar with how it was developed. The staffers had limited input in drafting the document, those people said.

The guidance covers certain injectable peptides popular in the wellness industry. It recently went through regulatory review at the White House, which is typically the last step before publication. Three of the people said it would tell the FDA not to act against specialty pharmacies that sell certain widely used peptides. Those substances would otherwise count as illegal drugs because they have not passed the agency's review for safety and effectiveness.

The people spoke to The Associated Press on condition of anonymity to discuss confidential government deliberations. A spokesperson for the Department of Health and Human Services did not immediately respond to requests for comment.

Some peptides occur naturally in the body, where they trigger hormones involved in growth, metabolism and healing. Drug companies have turned several into medications, including mainstay treatments for diabetes and weight loss. The substances covered by the new policy have not been through that vetting. They include BPC-157 and TB-500, which are promoted as aids for healing injuries and building muscle, and which international sports authorities consider doping substances. Kennedy has called himself a "big fan" of peptides and recently described using BPC-157 to treat a muscle injury.

According to two of the people, the guidance is a step back from the department's original plans. HHS officials first wanted the FDA to write a formal regulation adding BPC-157 and other peptides to a list of substances considered safe for compounding pharmacies, which make customized medications. FDA officials warned that agency scientists had major safety concerns and would not back a rule deeming the peptides safe. HHS then shifted to directing the FDA not to enforce its rules against pharmacies that compound them. That approach avoids a direct clash with FDA staff.

FDA staffers ultimately gave technical help on the plan, including safeguards meant to improve safety. Pharmacies would have to source peptide ingredients from FDA-regulated factories, collect information on side effects for safety analysis, and verify the chemical identity of the peptides. Some industry groups support those measures, including the Alliance for Pharmacy Compounding, which recently met with White House officials about the proposal.

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. Many people using peptides today skip doctors and pharmacies, ordering vials online from Chinese chemical manufacturers. Sellers often label them "for research use only" to avoid U.S. rules, since the FDA does not regulate research chemicals.

Decisions on peptides and compounding pharmacies have almost always come from the FDA, which has an office dedicated to guarding against unsafe or poor-quality compounded drugs. Compounding drew greater scrutiny after a deadly fungal meningitis outbreak in 2012 was traced to contaminated injections from a Massachusetts compounding pharmacy. Once a niche business, it has grown into a multibillion-dollar industry. Former FDA officials say it is extremely rare for HHS to lead policy drafting in this area, though federal law technically gives HHS authority over essentially all drug regulation, which it delegates to the FDA.

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 such as 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 for safety and effectiveness.