The floodgates are expected to open up for several peptides previously restricted by the Food and Drug Administration.
This week, an advisory panel assembled by the FDA weighed in on whether compounding pharmacies should be allowed to produce seven peptides currently placed on a banned list. The panel ultimately recommended giving the green light to nearly every peptide up for review over the objection of career scientists at the FDA. With these unapproved drugs set to be more widely available than ever before, here’s what you should know about them.
The unknowns of peptides
Peptides are simple chains of two or more amino acids. In the human body, many peptides play an important role in maintaining our health, either as hormones, neurotransmitters, or other kinds of signaling molecules.
Researchers and drug companies have adapted some peptides into medical treatments, such as semaglutide, the active ingredient in Ozempic and Wegovy. Lots of other peptides, however, are still being tested in clinical trials, were abandoned early on in development, or aren’t approved in countries like the U.S. And it’s these unapproved, unregulated peptides that have received lots of attention from the federal government lately, particularly Robert F. Kennedy Jr.
RFK Jr. has pledged to end what he’s called the FDA’s “war on peptides.” Specifically, he intends to remove certain peptides from the FDA’s Category 2 list of bulk drug substances for use in compounding. This list covers compounds that the FDA deems too unsafe for compounding pharmacies to produce, even with permission from a doctor. Kennedy has stated there are at least 14 peptides that he hopes to remove from the list, but this latest meeting of the FDA’s Pharmacy Compounding Advisory Committee, held July 23rd and July 24th, covers only seven: BPC-157, KPV, TB-500, MOTs-C, emideltide, semax, and epitalon.
What’s coming off the list?
Over the span of two days, the panel said yes in a majority vote to six of these peptides being stricken from the Category 2 list: BPC-157, KPV, TB-500, MOTs-C, epitalon, and semax. It only said no to emideltide.
BPC-157 is claimed to boost healing and has been studied as a potential treatment for ulcerative colitis. KPV has been studied as an anti-inflammatory agent that can speed up wound healing. TB-500 is intended to mimic the effects of the larger naturally produced protein thymosin beta-4 and is purported to accelerate muscle and soft tissue regeneration, making it useful for injury recovery. MOTs-C may help induce some of the positive bodily effects seen with physical exercise and has been looked at as a potential treatment for obesity and diabetes. Epitalon has been studied as a potential anti-aging and insomnia treatment. And semax is purported to have neuroprotective and nootropic (cognition-boosting) properties.
Some of these compounds have more evidence behind them than others, but most haven’t been tested out in large-scale human trials at all (semax is an approved drug, but only in some Eastern European countries). And the FDA’s scientists had argued that none have the effectiveness or safety data warranted to remove them from the Category 2 list. Yet it appears the deck was always going to be stacked against the peptide-cautious side.
Prior to this week’s meeting, the Department of Health and Human Services added several new members to the advisory committee, most of whom have clear financial ties to the growing peptide industry. Notably, each of the votes for recommending these peptides passed narrowly, with these panelists often voting yes.
The recommendations of this panel are non-binding, but with Kennedy’s backing, it seems unlikely these votes will be ignored. Even in more usual times, the FDA rarely disagrees with the decisions passed by its advisory committees. So barring any huge surprises, there will soon be many more peptides widely accessible to the public. How safe or effective any of them really are is a question that no one currently has the answer to.
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