Tomorrow and Friday, the Food and Drug Administration’s (FDA) Pharmacy Compounding Advisory Committee (PCAC) will vote on whether to recommend approval of seven peptides that were previously banned resulting from health risks. The proposal faces opposition from FDA scientists.
With Health and Human Services Secretary Robert F. Kennedy Jr. saying he used peptides, advocate openly for approvaland a PCAC board filled with members who run clinics, pharmacies or online businesses promoting peptides, there may be little doubt concerning the final result.
Peptide gray area
The peptides considered by the PCAC are among the many peptides classified as Category 2 by the FDA. This means they weren’t adequately tested or were deemed unsafe for compounding. Compounding is the technique of mixing or changing medications for individual patients.
The FDA eliminated compounding categories 2 and three in January 2025. This has raised some questions on the legal use of the peptides that the PCAC is considering.
“I can’t find any reason why we should make an exception for peptides – from these particular ones,” Egle Pavyde, Doctor of Regenerative Medicine, said SavingAdvice. “On the other hand, we have numerous peptides that have gone all the way and been approved by the FDA or EMA. Insulin, GLP-1 agonists, to name a few. If certain peptides have been researched but no further progress has been made, there must be a reason for this. And that reason is usually lack of efficacy, safety, or even both.”
What are peptides?
Peptides are short chains of amino acids (molecules) that occur naturally within the body. Think of them as constructing blocks for protein. However, the peptides considered by the PCAC are all synthetic, meaning they’re chemically produced to mimic natural peptides.
The concern with these synthetic peptides is the shortage of research on their safety and effectiveness.
What do naturally occurring peptides do?
The tons of of naturally produced peptides in your body communicate with cells and organs to stabilize body function.
This process, called HomeostasisThis may include a peptide that binds to a single cell and signals it to activate a gene or release a hormone. More broadly, peptides regulate metabolism, immune response, digestion, sleep and tissue healing.
FDA scientists criticize lack of testing and health risks
Experienced FDA scientists have submitted one Briefing document to the committee that opposes making the seven peptides legal for production. The document is definitely a series of comments opposing the lifting of restrictions on considered one of the peptides under advice.
Editor’s note: The “Briefing document” link within the previous paragraph takes you to the briefing documents. To view FDA scientists’ comments, scroll to the Event Materials section below. There you will notice a link to every briefing document for every peptide.
FDA scientists’ essential objections to a positive advice for the peptides give attention to three areas:
- Insufficient data: For KPV, TB-500 and MOTS-c, the FDA states that there isn’t a clinical evidence in humans. For BPC-157, Emideltide, and Semax, the objections highlight that available human studies are tiny, completely uncontrolled, or provide conflicting data.
- Inconsistencies: The FDA points to a serious lack of standardization amongst chemical manufacturers. Vendors mix different iterations—resembling the free base form with the acetate salt form—without data proving that they behave the identical way within the human body.
- Immune risks: Peptides are sometimes administered by injection. FDA staff warned that this may lead to severe immune or toxic reactions resulting from impurities.
The FDA’s concerns are shared by other experts
“Real peptide drugs such as insulin or the GLP-1 drug class have been very well studied and are used for very real purposes,” Dr. Stephen Cosentino, DO, founder and medical director of Medical Education of the Empiresaid SavingAdvice.
Empire Medical Training provides medical education and training related to peptides and regenerative medicine.
“We trust these drugs, so people extend that trust to any peptide they find online. Well, peptides have different effects, and not all of them affect hunger. Some mediate hormones, others have been studied as tissue repair agents; many of them have no human data. People think that because it’s ‘natural,’ it must be safe, but that’s not the case,” says Dr. Cosentino.
“I agree with FDA scientists that the lack of long-term safety and efficacy of such peptides and the challenges in ensuring quality control and characterization of peptides raise significant questions about the suitability of these compounds for pharmaceutical compounding,” says Pankti Shah, PharmD at PharmaLink Academy.
“I really hope that the voice of the experts is heard,” says Pavyde. “If you look at the published data for these particular peptides, there is a lack of human data; some clinical trials were started but stopped, the results were not published, the reasons for stopping were not disclosed. This raises many questions and concerns.”
The approval process
In the event of a positive advice, the FDA would then initiate a proper review, which could last a yr or two. The approved peptides, if any, can be moved to the agency’s Section 503A bulk drug substance list. This would make them legally available to compounding pharmacies.
The process could only be expedited if the FDA or Department of Health and Human Services grants approval “Discretionary decision on provisional enforcement”. This would allow their use throughout the official verification process.
Committee Members and Conflicts of Interest
Of the twelve PCAC members, eight were appointed on June 29. All but considered one of the brand new members have financial ties to medical practices and health care corporations that sell or administer synthetic peptides. That raises questions on the conflicts of interest they face when making recommendations about something that may profit them.
“It is good that there is transparency about which committee members have ties to the peptide industry, but it creates a bias,” says Dr. Cosentino, “especially when the people who could benefit from expanded access are the ones making the decision.”
Dr. Cosentino blames political interference for creating the bias.
“We see political figures like RFK Jr. amplifying his opinion on podcasts and the trending topics of peptides for anti-aging, weight loss and growth hormones,” says Dr. Cosentino. “Of course, outside of the committee members, we are in a world of bias against peptides, which is why the FDA’s decision must remain neutral.”
Government regulator flags FDA conflict of interest deficiencies
The Government Accountability Office (GAO) noted in a March report that FDA advisory committees have to be more open. It was titled FDA Advisory Committees: More Transparency Needed in Conflict of Interest Determination Policies.
The GAO is a nonpartisan agency that reports to Congress. It examines how taxpayer dollars are spent with the goal of creating recommendations for tactics to make government agencies and programs more efficient, effective, and accountable.
In the Fast facts section The authors wrote concerning the report: “We reviewed the FDA’s conflict of interest review process and determined that the guidelines for determining whether a financial conflict exists have not yet been finalized. The FDA also does not publicly disclose how these decisions are made. Official guidance and greater transparency could help ensure FDA decisions are consistent and understandable.”
Later, the report explains requirements that prohibit committee members from attending meetings that may gain advantage them financially.
“Government-wide requirements prohibit committee members from attending meetings that could harm their financial interests,” the report said. “The FDA screens for conflicts of interest by reviewing a form that committee members fill out to disclose financial interests, such as investments in pharmaceutical companies. The regulations also require the FDA to look for items that might appear that a committee member lacks impartiality. In some situations, the FDA may grant a waiver or authorize a member to attend a meeting, such as when the member’s need for expertise outweighs the potential conflict.”
How did HHS use the conflict of interest waiver?
HHS used waivers Enforce nominations with conflicts of interest. They relied on two arguments.
First, they claimed that peptides and regenerative medicine were specialties. Therefore, the agency claimed that the experts with the very best expertise were those who prescribed them.
Second, HHS argued that the appointees’ conflicts affected a complete industry and never a single company. Therefore, HHS said, her conflicts of interest might be classified as “broad sector interests,” making her appointment possible. Individual conflicts of interest, resembling owning shares in an organization, can be disqualifying.
This sets the stage for 2 days of PCAC hearings. They might be as glib and boring as a rubber-stamped endorsement of private interests. On the opposite hand, it could also grow to be a debate about science and public safety. Stay tuned.
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Max K. Erkiletian is an experienced journalist and analytical reporter with almost 40 years of experience. He has been nominated for several awards and was a part of a team that won the Missouri Press Association’s Community Service Award.
His experience includes covering a wide selection of topics, from crime reporting to politics and music. His interview subjects included U.S. Senators resembling Tom Eagleton; economists like Arthur Laffer; former Fed Chairman Paul Volcker; and musicians like Muddy Waters and BB King.
Today he focuses on personal finance, consumer protection, economic changes and investing trends. The aim of his reporting is to make complex issues comprehensible and to indicate how events affect consumers’ wallets.
