In a widely expected move, a committee organized by the Food and Drug Administration (FDA) has voted to endorse removing restrictions on the manufacture of peptides for human use. Thursday’s panel meeting saw a sharply divided group recommend lifting limits on four peptides; votes on three additional peptides are scheduled for today. The move comes despite a continuing lack of evidence regarding their safety and effectiveness.
The move had been telegraphed months earlier as peptide enthusiast and Health and Human Services Secretary Robert F. Kennedy Jr. took steps to ensure this outcome.
Like proteins, peptides are composed of amino acids that are chemically linked into a chain. Peptides differ merely by length; they’re often 10–20 amino acids long, in contrast to proteins, which can be hundreds or thousands. Some of them, such as insulin, are specifically made by targeted processing of a protein into shorter fragments, and the resulting peptide interacts with receptors that have evolved to send signals to cells based on its levels.
But a lot of peptides are just the result of the messy complexity of biology, where larger proteins may break down in a way that consistently produces a stereotypical pattern of fragments. Some of those fragments, being relatively short and flexible, may stick to other proteins in ways that trigger some sort of physiological response. Others may simply be digested and recycled without doing anything of note.
Understanding how a peptide is made and what downstream effects it triggers can take decades of research. In many cases, we have some evidence of what happens when we expose cultured cells to a peptide, but lack any indication of what might happen if an intact animal is. (Notably, transiting this same evidentiary gap is often where promising-looking drug candidates turn into failed ones.)
RFK Jr. and many like him, who fear the clearly defined and well-understood proteins in vaccines, are perfectly willing to inject various peptides in the complete absence of any safety data. However, unlike most of the peptide fans who share anecdotes online, Kennedy is in a position to turn his hobby into policy.
While the FDA has already used its standard processes to approve peptide drugs like insulin and some recently developed weight loss drugs, the lack of safety and efficacy data has kept most peptides off the market. The Biden administration also blocked their manufacture by compounding pharmacies, which make specialty drugs. But, earlier this year, Kennedy announced his interest in reversing that ban.
At the time of his announcement, Ars’ Beth Mole wrote, “Outside experts and watchdogs suspect that before the first meeting in July, Kennedy will work to stack the advisory board with questionably qualified allies who will come with a predetermined decision to ease access to the drugs—no rigorous scientific evaluation needed.” That’s exactly what came to pass. In June, Kennedy added members to the advisory group who, with one exception, had obvious interests in the manufacture and sale of the unapproved peptides.
Yesterday, those newly appointed members provided the decisive votes for overturning the ban, with all of the pre-Kennedy members voting against doing so. Despite Kennedy’s earlier claim that “independent experts will rigorously evaluate each substance on its scientific merits using full clinical, pharmacological, and safety evidence,” no such evidence was presented at the meeting.
According to The New York Times, when asked by a committee member whether the FDA had ever approved anything that had never been tested in humans before, an FDA official said it had not. That may be a critical factor in what happens next. The committee’s role is advisory, and the FDA could reject its recommendations. Doing so, however, would place the FDA’s experts in direct conflict with the wishes of Kennedy, who can simply fire them.
