▶ Watch Video: FDA panel considers loosening regulations on certain unapproved peptides
A Food and Drug Administration advisory panel voted to broaden access to six peptides, amid a surge of interest in the unapproved therapies. The votes took place during a two-day meeting discussing whether compounding pharmacies can fill prescriptions for some unapproved peptides.
Peptides are short strings of amino acids, the building blocks of proteins, linked by chemical bonds. The human body naturally produces some peptides, and more than 80 peptides have been approved for use by the FDA. Those approved peptides can be found in things like insulin, skincare products and GLP-1 medications.
Recently, there has been a surge in demand for unapproved peptides, which are typically sold as “research use only” and lack scientific evidence, such as clinical data or human trials, to back up their claims. Some unapproved peptides advertised by influencers online claim to be able to slow aging or increase muscle growth. Health and Human Services Secretary Robert F. Kennedy Jr. said he is a “big fan” of the unapproved therapies and that he has used them to help with injuries.
FDA advisory panel reviewed seven peptides
The panel reviewed four peptides during the first day of its two-day meeting, and voted 8-6 that each should be added to a list of substances that can be safely produced by compounding pharmacies, which mix medications that aren’t available from standard drugmakers. Two more received votes of support on Friday.
Patients will need a doctor’s prescription and need to be treating a specific medical condition. The decision does not constitute FDA approval. Telehealth companies are expected to increase marketing for the therapies following the ruling, The Associated Press reported.
In its first session Thursday, the panel discussed the peptide BPC-157, which is one of the most popular among longevity and wellness influencers. It is marketed as being able to heal injuries and reduce inflammation.
Among the 24 speakers who commented on BPC-157 were four scientists who said the drug should not be made more accessible. The remaining 20 were doctors, chemists and peptide business owners who were in favor of the peptide’s approval. They used personal and patient anecdotes to explain why they believed access should be expanded.
NYU Langone’s Dr. Rachel Pessah-Pollack told “CBS Mornings” that BPC-157 has only been tested in about 30 humans, as compared to the hundreds of thousands of patients GLP-1s were tested on.
“Anecdotes are not evidence,” Pessah-Pollack said Thursday, ahead of the panel.
The other peptides added to the list are known as TB-500, MOTS-c and KPV. Three more peptides were considered on Friday, and two of them, Semax and Epitalon, were also approved.
Products sold on the “gray market”
Dr. Jessica Duncan, the chief medical officer for IVIM Health, a for-profit company that prescribes FDA-approved peptides, said she believes that because there is demand for the unapproved therapies, the FDA should work to ensure they can be provided by doctors.
“People want them. They have proven to us that they are going to seek them out,” Duncan told CBS News before testifying at the panel. “What I’m asking and advocating for is that the conversation with them, the education that’s provided, is in the exam room.”
Many peptides can be purchased online, in a space known as the “gray market,” which practitioners have called risky because of the potential for contamination or impurities.
“At this point, we all need to be wary about putting an injection in your body without actually knowing the product,” said Pessah-Pollack. “I mean, they could have arsenic in it, they could have lead. So we all need to pause. We all need to speak to our doctors.”
During the Biden administration, the FDA added nearly 20 peptides to the federal list of substances that should not be produced by compounding pharmacies. The FDA panel said at the time that the peptides did not meet the criteria for substances that can be safely compounded. FDA regulators said at the time that the substances “present significant safety risks” because of the lack of testing.
Many of the FDA advisers and internal staff present for that decision no longer work for the agency. More than half a dozen people with connections to the peptide industry were added to the panel before the discussion, according to the Associated Press, including doctors, pharmacists and consultants who work with the chemicals. All of those experts voted to allow pharmacies to produce their own formulations of BPC-157.
Former FDA official Dr. Peter Lurie, who now leads the Center for Science in the Public Interest, told CBS News in April that he believed Kennedy’s statements made it unlikely that unapproved peptides would receive real scrutiny at the hearing.
“Everybody knows the outcome that the secretary wants,” Lurie said. “I don’t believe for one moment that what’s going on here is an honest investigation of whether these products should be compounded.”
