FDA Staffers Blocked Draft Peptide Rule

The scientific staff at the Food and Drug Administration opposed a draft policy that would ease access to unproven peptide drugs, according to six people familiar with the process. The guidance, which supports a priority for Health Secretary Robert F. Kennedy Jr., is now in its final regulatory review at the White House.

The proposed rule targets specific injectable peptides popular in the wellness sector. It would instruct the FDA to stop enforcing rules against specialty pharmacies that sell these compounds. Without this change, the substances remain illegal drugs because they have not passed the agency's standard review for safety and effectiveness.

Three of the sources stated that the document would cover peptides such as BPC-157 and TB-500. These substances are marketed as aids for injury healing and muscle growth. International sports authorities classify them as doping substances. Kennedy, who has called himself a big fan of peptides, recently described using BPC-157 to treat a muscle injury.

HHS officials initially planned a more aggressive approach. They wanted the FDA to write a formal regulation adding these peptides to a list of substances considered safe for compounding pharmacies. FDA officials warned that agency scientists had major safety concerns and would not support a rule deeming the peptides safe.

The department then shifted strategy. Instead of declaring the peptides safe, HHS decided to direct the FDA to simply stop enforcing its rules against pharmacies that compound them. Two sources described this shift as a step back from the department's original plans. This approach avoids a direct clash with FDA staff.

FDA staffers provided technical help on the final plan, including safeguards meant to improve safety. Pharmacies would have to source peptide ingredients from FDA-regulated factories. They would also need to collect information on side effects and verify the chemical identity of the peptides. The Alliance for Pharmacy Compounding, which met with White House officials about the proposal, supports those measures.

Kennedy has argued that U.S. compounding pharmacies must be allowed to sell peptides. He claims Americans are currently turning to gray market products imported from China and other countries. Many users skip doctors and pharmacies, ordering vials online from Chinese chemical manufacturers. Sellers often label these products for research use only to avoid U.S. rules.

Decisions on peptides and compounding pharmacies have almost always come from the FDA. The agency has an office dedicated to guarding against unsafe compounded drugs. Compounding drew greater scrutiny after a deadly fungal meningitis outbreak in 2012 was traced to contaminated injections from a Massachusetts pharmacy. The industry has since grown into a multibillion-dollar business.

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 drug regulation. 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. Cited risks included 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.