White House Policy Shifts FDA Stance on Unapproved Peptides

The White House is moving to loosen federal rules on experimental peptides, a class of compounds that have gained popularity in longevity clinics but have not received FDA approval for safety or effectiveness.

On October 14, a temporary access policy appeared on a federal docket. The proposal would permit licensed pharmacies to manufacture and sell certain unapproved peptides directly to patients. This action followed a July meeting where FDA scientists warned against the measure, citing a lack of adequate clinical trial data.

An FDA advisory panel voted to support loosening the restrictions. Many members of this panel are new appointees who hold financial interests in the peptide industry. Department of Health and Human Services spokesperson Emily Hilliard stated in an email that every committee member meets the agency's ethics requirements.

Haleem Mohammed, a new panel member and chief medical officer of Gameday Men’s Health, voted in favor of the change. He cited patient safety and medical freedom as his reasons. His clinic sells peptides to male patients.

Promoters of these compounds often argue that they are not drugs because they are natural substances. Gary Brecka, a co-chair of the MAHA Action committee, has described peptides on his podcast as tools to regulate cortisol and improve circulation. However, legal experts note that when a substance is used to treat or prevent a condition, it fits the definition of a drug.

Jacob Sherkow, a law professor at the University of Illinois Urbana-Champaign, compared the argument to claiming heroin is not a drug just because it has natural origins. He emphasized that most drugs have antecedents in nature.

Critics point to BPC-157 as an example of a popular peptide with unclear biological origins. Developed by Croatian scientists, it was isolated from gastric juices. Katrin Svensson, a peptide scientist at Stanford University, noted that researchers have not found a trace of BPC-157 in the human genome. This suggests it is not produced by the human body, contradicting claims made by some influencers.

Clinical evidence for these compounds remains limited. A 2005 study on BPC-157 for inflammatory bowel disease was deemed inadequate by FDA reviewers due to missing methodological details. Another small study found relief for knee pain in 14 of 16 participants but lacked a control group. Flynn McGuire, a rehabilitation doctor at the University of Utah, told patients he will not prescribe BPC-157 until higher quality studies are available.

The pharmaceutical industry has expressed concern that easier access for compounding pharmacies will reduce the incentive to conduct expensive clinical trials. The trade organization PhRMA advised against the policy shift, warning it would erode the motivation for manufacturers to seek full FDA approval. The market for related GLP-1 drugs is projected to reach $190 billion in the next decade, according to Morgan Stanley.

Supporters of the policy note that the U.S. spends more per person on healthcare than any other nation while ranking below other wealthy countries in life expectancy. Six in 10 U.S. adults worry about affording prescription drugs, according to a recent KFF poll. The new policy aims to expand access to these treatments while the regulatory process continues.