The U.S. Food and Drug Administration’s Pharmacy Compounding Advisory Committee has voted in favor of two controversial peptides so far, with five more to go.
But questions are being raised about whether committee members are recommending them based on financial interest.
Peptides are commonly found in weight-loss drugs and insulin. They are not new. More than 170 of them are in active development, but many new peptides entering the market have not been methodically tested in humans.
These peptides have been popularized by the “biohacking” community on social media. People take them for muscle recovery, sleep, cognitive function, weight loss and more.
Peptides have developed into a $70 billion market. Clinics and medical practitioners sell them.
Some members of the Pharmacy Compounding Advisory Committee have a financial conflict of interest with peptides, said Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University Medical Center.
“These are unapproved drugs, and many of them that are being considered here today have not been tested on humans at all,” said Fugh-Berman, who gave public comments about the lack of associated research. “They just recently put six people [on the committee] who have major conflicts of interest in terms of selling peptides or running clinics that have peptides.”
Health and Human Services Secretary Robert F. Kennedy Jr. has shared his positive experiences using peptides and has been trying to reverse the Biden administration’s 2023 restrictions on 19 popular peptides.
Dr. Alex Tatem, a licensed urologist specializing in men’s health, said he has been unable to prescribe the treatment to his patients because of the Biden administration’s restrictions, which led him and others to source their peptides from unrestricted markets.
“That was really challenging to sit across from patients and tell them, […] I know it’s provided an answer for you where traditional medication didn’t, but unfortunately, it’s out of our hands,” Tatem said. “We can no longer provide this for you.”
One patient, Tatem added, “went online and started buying these peptides from sources that aren’t vetted and honestly are coming from China. It moved it to the black and gray market where you don’t have assurances in quality, sterility.”
The committee has voted to recommend that the FDA allow them to be compounded into other medications, with the FDA following its advice most of the time. Another series of peptides is also set to be reviewed next year.
