FDA panel to consider loosening regulations for some peptides
Food and Drug Administration advisory panel A two-day panel discussing whether compounding pharmacies should fill prescriptions for some unapproved peptides voted to expand access to at least one peptide. The meeting took place at a time when interest was increasing unapproved treatments.
Peptides are short strings of amino acids that are the building blocks of proteins and are linked together by chemical bonds. The human body naturally produces some peptides, and more than 80 peptides have been approved for use by the FDA. These approved peptides are used in insulin, skin care products and GLP-1 drugs.
Recently, there has been an increase in demand for unapproved peptides, which are typically sold as “research purposes only” and lack scientific evidence such as clinical data or human trials to support their claims. Some unapproved peptides advertised online by influencers claim that you can to slow down aging or increase muscle growth. Health and Human Services Secretary Robert F. Kennedy Jr. said he is a “big fan” of unapproved treatments and uses them to help with injuries.
The panel is examining seven peptides and will decide whether they should be added to the list of substances that can be safely produced by compounding pharmacies with drugs not available from standard drug manufacturers. Patients will need a doctor’s prescription and will need to receive treatment for a specific medical condition. The decision does not imply FDA approval.
In the first session on Thursday, the panel discussed the BPC-157 peptide, one of the most popular for longevity and wellness. 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 people were doctors, chemists and peptide business owners who were in favor of approving the peptide. They used personal and patient anecdotes to explain why they believe access should be expanded. On Thursday afternoon, the panel voted 8-6 to expand access to the chemical.
Dr. from NYU Langone Rachel Pessah-Pollack told CBS Mornings on Thursday that BPC-157 has only been tested in about 30 people, compared to the hundreds of thousands of patients in whom GLP-1s have been tested.
“Anecdotes are not evidence,” Pessah-Pollack said before the panel Thursday.
D., chief medical officer of IVIM Health, a nonprofit company that prescribes FDA-approved peptides. Jessica Duncan said she believes that because there is demand for unapproved treatments, the FDA should work to make sure they are available to doctors.
“People want them. They’ve proven to us that they will seek them out,” said Duncan, who is scheduled to testify before the panel. he told CBS News. “What I want and what I advocate for is for the conversation with them and the education that is given to be in the exam room.”
Many peptides can be purchased online in an area known as the “grey market,” which practitioners describe as risky due to the potential for contamination or impurities.
“At this point, we all need to be careful about injecting into your body without actually knowing the product,” Pessah-Pollack said. “I mean, they might have arsenic in them, they might have lead. So we all need to take a moment. We all need to talk to our doctors.”
During the Biden administration, the FDA added nearly 20 peptides to the federal list of substances that pharmacies should not manufacture through compounding. The FDA panel said at the time that the peptides did not meet criteria for substances that could be combined safely. FDA regulators said at the time that the substances “pose significant safety risks” due to a lack of testing.
Many of the FDA advisors and internal staff present for this decision no longer work for the agency. More than a half-dozen people with ties to the peptide industry were added to the panel ahead of the discussion, including doctors, pharmacists and consultants who work with chemicals, according to the Associated Press. All of these experts voted to allow pharmacies to manufacture their own formulations of BPC-157.
Former FDA official Dr. D., who now directs the Center for Science in the Public Interest. Peter Lurie told CBS News in April he believed it. Kennedy’s statements eliminated the possibility that unapproved peptides would face real scrutiny at trial.
“Everyone knows the outcome the secretary wants,” Lurie said. “I don’t believe for a second that what’s going on here is an honest investigation into whether these products should be put together.”
