Health Secretary Proposes Increased Access to Unapproved Peptides for Wellness

Introduction

Health and Human Services Secretary Robert F. Kennedy Jr. recently took measures to potentially increase access to certain unapproved peptide drugs marketed for wellness. These peptides have not received approval from the Food and Drug Administration (FDA), yet are gaining attention due to their potential benefits.

New Draft Policy

A draft policy released on Wednesday suggests that compounding pharmacies will be permitted to prepare six specific peptides. These are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. Kennedy emphasized that this approach offers patients a controlled alternative despite the absence of FDA approval.

By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative,” Kennedy said.

Compounding Pharmacies

Compounding pharmacies have the ability to create customized medications by mixing specific ingredients for individual patients. Although the peptides are not FDA approved, they often carry health claims in the marketplace.

The Department of Health and Human Services has indicated a lack of intention to penalize licensed pharmacies or physicians that compound such peptide drug products.

FDA Advisory and Safety Concerns

Peptides are small proteins known for their potent effects, with several, such as insulin, achieving FDA approval for safety and efficacy. GLP-1 medications, used for weight loss and diabetes treatment, also contain FDA-approved peptides.

Earlier, an FDA advisory panel had recommended permitting these unapproved peptides for compounding, despite opposition from FDA scientists who lacked sufficient evidence of their safety and effectiveness.

Kennedy’s decision “advances patient choice and freedom while appropriately protecting patient safety,” he noted.

Quality Testing and Accountability

The policy mandates pharmacies engaging in compounding to conduct quality testing and safety reporting. This measure aims to help patients identify the components within peptide products sold by unregulated sources.

The policy does not grant FDA approval or establish clinical safety and effectiveness,” stated an HHS spokesperson.

Further requirements include patient-specific prescriptions, traceable ingredient sourcing, quality testing, and serious side effect reporting.

Investigative Findings

A CBS News investigation previously analyzed an experimental peptide weight-loss drug called retatrutide, purchased in Brooklyn, New York. Laboratory findings revealed the sample lacked any peptides.

Furthermore, numerous clinics nationwide were found advertising retatrutide, despite its ongoing clinical trials and lack of FDA review.

Public Commentary Period

Kennedy’s draft policy will open for public commentary from Friday until November 13. While the policy will be effective until the FDA finalizes a rule on compounded peptides, no such rule has been proposed yet.

Contributions to the report came from Dr. Céline Gounder, Adam Yamaguchi, and Kerry Breen.