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 previously banned due to health risks. The proposal faces opposition from FDA scientists.
With Health and Human Services Secretary Robert F. Kennedy, Jr., who says he has used peptides, openly advocating for approval, and a PCAC board stacked with members who operate clinics, pharmacies, or online businesses that promote peptides, there is little doubt about the outcome.
Peptide Gray Area
The peptides that will be considered by the PCAC are among a number that had been placed in the FDA’s Category 2. That meant they had not been sufficiently tested or were considered unsafe for compounding. Compounding is the mixing or altering of drugs for individual patients.
The FDA eliminated compounding categories 2 and 3 in January 2025. That has raised some questions about the legal use of the peptides the PCAC is considering.
“I cannot find a reason why we should make an exception for peptides – to these particular ones,” Egle Pavyde, PhD in Regenerative Medicine, told SavingAdvice. “On the other hand, we have numerous peptides which have gone all the way and were approved by the FDA or EMA. Insulin, GLP-1 agonists, to name a few. If certain peptides were researched but have not progressed further, there must be a reason for that. And that reason is usually the lack of efficacy, safety, or even both.”
What Are Peptides?
Peptides are short chains of amino acids (molecules) that occur naturally in the body. Think of them as building blocks for protein. However, the peptides the PCAC will consider are all synthetic, meaning they are chemically created to mimic natural peptides.
The concern with these synthetic peptides is the lack of research about their safety and effectiveness.
What Do Naturally Occurring Peptides Do?
The hundreds of naturally produced peptides in your body communicate with cells and organs to stabilize body function.
That process, called homeostasis, can include a peptide attaching to an individual cell and signaling it to turn on a gene or release a hormone. On a broader scale, peptides regulate metabolism, immune response, digestion, sleep, and tissue healing.
FDA Scientists Challenge Lack of Testing and Health Risks
Veteran FDA scientists have submitted a briefing document to the committee opposing making the seven peptides legal for compounding. The document is actually a series of comments opposing lifting restrictions on any of the peptides up for recommendation.
Editor’s Note: The “briefing document” link in the preceding paragraph takes you to the briefing documents. To view the FDA scientists’ comments, you have to scroll to the “Event Materials” section at the bottom. There you will see a link to each briefing document for each peptide.
The FDA scientists’ main objections to a positive recommendation for the peptides center on three areas:
- Insufficient Data: For KPV, TB-500, and MOTS-c, the FDA notes there is no human clinical evidence. For BPC-157, Emideltide, and Semax, the objections highlight that available human studies are tiny, completely uncontrolled, or yield contradictory data.
- Inconsistencies: The FDA details a severe lack of standardization between chemical manufacturers. Providers are compounding varying iterations—such as the free base form versus the acetate salt form—without data proving they behave the same way in the human body.
- Immune Risks: Peptides are frequently administered by injection. The FDA staff warned that this could result in severe immune or toxic reactions due to contaminants.
FDA Concerns Shared Among Other Professionals
“Real peptide medications like insulin, or the GLP-1 drug class, are very well studied and used for very real purposes,” Dr. Stephen Cosentino, DO, Founder and Medical Director of Empire Medical Training, told SavingAdvice.
Empire Medical Training provides medical education and training related to peptides and regenerative medicine.
“We trust those medications, so people extend that trust to every peptide they find online. Well, peptides have different effects, and not all of them affect hunger. Some mediate hormones; others have been researched as tissue repair agents; many of them have zero human data. People think because it’s ‘natural’ it must be safe; it is not,” says Dr. Cosentino.
“I agree with FDA scientists in that the absence of the long-term safety and efficacy of such peptides, and the challenges of assuring quality control and characterization of peptides, raise significant questions as to the appropriateness of these compounds being made available for pharmacy compounding,” says Pankti Shah, PharmD at PharmaLink Academy.
“I really hope that the voice of the experts will be heard,” says Pavyde. “If you look to the published data for these particular peptides, there is a lack of human data; some clinical studies were started but discontinued, results not published, reasons for discontinuation undisclosed. This raises many questions and concerns.”
The Approval Process
If a positive recommendation is made, the FDA would then launch a formal review, which could take one or two years. The approved peptides, if any, would be moved to the agency’s Section 503A Bulk Drug Substances List. That would make them legally available to compounding pharmacies.
The only way the process could be sped up is if the FDA or Department of Health and Human Services issued an “interim enforcement discretion” ruling that would allow their use while the official review process plays out.
Committee Members & Conflicts of Interest
Of the 12 PCAC members, eight were appointed June 29. All but one of the new appointees have financial ties to medical practices and health businesses that sell or administer synthetic peptides. That raises questions about the conflicts of interest they face in making recommendations about something they will profit from.
“It is good that there is transparency of which committee members have ties to the peptide industry, but it does create a bias,” says Dr. Cosentino, “especially when the people who stand to gain from growing access are the ones making the decision.”
Dr. Cosentino blames political interference for shaping the bias.
“We are seeing political figures like RFK Jr boost his opinions on podcasts and the trending topics of peptides for anti-aging, weight loss, and growth hormones,” says Dr. Cosentino. “Outside of the committee members, we are naturally sitting in a world of bias around peptides, which is why the FDA decision must remain neutral.”
Government Watchdog Cites FDA Conflict of Interest Flaws
The Government Accountability Office (GAO) singled out the need for FDA advisory committees to be more forthcoming in a March report. It was titled FDA Advisory Committees: More Transparency Needed on Policies for Making Conflict of Interest Determinations.
The GAO is a non-partisan agency that reports to Congress. It investigates how taxpayer money is spent with a goal of recommending ways government agencies and programs can be more efficient, effective, and accountable.
In the Fast Facts section of the report, the authors wrote: “We reviewed FDA’s conflict of interest review process, and found that it hasn’t finalized guidance on how to determine if a financial conflict exists. FDA also doesn’t publicly share how these decisions are made. Official guidance and more transparency could help ensure FDA decisions are consistent and accountable.”
Later, the report spells out the requirements that ban committee members from participating in meetings that could benefit them financially.
“Government-wide requirements prohibit committee members from taking part in meetings that could affect their financial interest,” states the report. “FDA checks for conflicts of interest by reviewing a form that committee members fill out to disclose financial interests, such as investments in drug companies. Regulations also require FDA to check for issues that could give the appearance that a committee member lacks impartiality. In some situations, FDA may grant a waiver or authorize a member to take part in a meeting, such as when the need for the member’s expertise outweighs the potential conflict.”
How Did HHS Use Conflict of Interest Waivers?
HHS used waivers to push through nominees with conflicts of interest. They were based on two arguments.
First, they contended that peptides and regenerative medicine are specialized fields. As a result, the agency maintained that the most knowledgeable experts were the people prescribing them.
Second, HHS argued the appointees’ conflicts involved an entire industry, not one company. Therefore, said HHS, their conflicts of interest could be classified as “broad sector interests,” allowing their appointments. Single conflicts of interest, such as stock ownership in a company, would be disqualifying.
So, the stage is set for two days of PCAC hearings. They could be as smooth and bland as a rubber stamp validation of vested interests. Then again, they just might turn into a debate about science and public safety. Stay tuned.
What to Read Next
Why Your Insulin Price Could Change Even When Your Insurance Plan Doesn’t
Ted Cruz Calls Trump Accounts a Path to Social Security Privatization—Economist Disagrees
Researchers Say Younger Generations May Be Aging Faster Than Their Parents Did
Max K. Erkiletian is a seasoned journalist and analytical reporter with nearly 40 years of experience. He has been nominated for several honors and was part of a team that won the Missouri Press Association’s Community Service Award.
His experience has included covering a wide range of topics, from crime reporting to politics and music. His interview subjects have included U.S. Senators, such as Tom Eagleton; economists, such as Arthur Laffer; former Fed Chair Paul Volcker; and musicians, such as Muddy Waters and B. B. King.
Today, he focuses on personal finance, consumer protection, economic shifts, and investment trends. His reporting aims to make complex issues understood and show how events impact consumers’ wallets.
Read the full article here
