FDA Panel Votes To Relax Rules On Unapproved Peptides Despite Safety Warnings
A White House policy proposal seeks to let pharmacies sell experimental compounds, a move that clashes with internal scientific advice and raises questions about conflicts of interest.
By Julia Novak ·
The U.S. healthcare system faces a persistent challenge: high costs and mixed health outcomes for its citizens. Against this backdrop, the federal government is moving to expand access to a class of experimental drugs known as peptides, a shift that has drawn criticism from scientists and industry groups.
On Oct. 14, a temporary access policy appeared on a White House docket. The proposal would allow licensed pharmacies to manufacture and sell certain unapproved peptides directly to consumers. This move follows a recommendation from a Federal Drug Administration (FDA) advisory panel that voted to loosen existing restrictions on these substances.
The FDA’s own scientists advised against the measure during a July meeting. They warned that the drugs had not been adequately vetted in clinical trials to ensure safety or effectiveness. Despite this internal guidance, the external panel voted to support easier access. Many of the panel members are recent appointees who hold financial stakes in the peptide industry.
Emily Hilliard, a spokesperson for the Department of Health and Human Services, stated in an email that every committee member meets the agency's ethics requirements. Haleem Mohammed, a new committee member and chief medical officer of Gameday Men’s Health, voted in favor of the change. At the July meeting, he said he voted for patient safety and medical freedom. His clinic sells peptides to men seeking body optimization.
Promoters of these compounds often argue that peptides are natural and therefore safe. However, the science does not support a simple distinction between natural and safe. BPC-157, one of the most popular experimental peptides, was isolated from gastric juices by Croatian scientists. 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, though some research indicates it may be made by stomach microbes.
Svensson emphasized that natural substances can still be toxic, citing insulin as an example of a natural peptide that can be lethal in high doses. She argued that while she is excited about peptide research, developers must prove the compounds are not harmful through placebo-controlled trials. These trials reveal long-term issues like liver damage that short-term use might miss. The FDA is currently considering lowering restrictions on BPC-157 and five other experimental peptides that lack high-quality clinical data.
Another common claim is that peptides cannot be patented, which some argue holds back big pharmaceutical investment. Jacob Sherkow, a law professor at the University of Illinois Urbana-Champaign, countered that while the natural substance itself may not be patentable, modified versions and delivery methods are. He pointed out that hundreds of peptide patents exist in the U.S. Patent and Trademark Office database. The market for GLP-1 peptide drugs, such as Ozempic, is projected to reach $190 billion in the next decade according to Morgan Stanley.
Critics say the new policy could further discourage large pharmaceutical companies from funding rigorous trials. PhRMA, the pharmaceutical trade organization, advised the FDA against easing restrictions in a letter. The group argued that the change would erode incentives for manufacturers to undertake the substantial time and cost required for full FDA approval. Pinchas Cohen, a gerontology scientist at the University of Southern California, said investors withdrew funding for a peptide he helped discover because they feared it could not compete with existing weight loss drugs.
Health officials and the Make America Healthy Again movement acknowledge that the U.S. spends more on healthcare per person than any other nation while ranking below other wealthy countries in life expectancy. A recent KFF poll found that six in 10 U.S. adults worry about affording prescription drugs. While these statistics support the need for cost reduction and better access, researchers note that skipping clinical trials to sell unproven treatments is not a standard solution for improving public health.
