Recently, I predicted that RFK Jr. may stack the key pharmacy compounding committee, called PCAC, with fans of unproven peptides. Kennedy wants the unproven “pop peptides”, as I call them, to be unleashed. If the PCAC advises allowing pop peptide compounding, it gives Kennedy more leverage to overrule FDA scientists.
You might recall there are literally zero good clinical trial data on these peptides such as BPC-157, Ipamorelin, etc. Further, the FDA previously banned compounding of these substances and for good reason. So, releasing these peptides from common-sense oversight would be highly risky.
Even I, with this prediction on the books, didn’t expect the newly reformed advisory committee to be so full of people already marketing peptides or with ties to these substances.
This does not seem like an impartial committee to me.
PCAC member Robert “Bobby” Harshbarger
The first name on the updated PCAC roster that struck me was Robert “Bobby” Harshbarger. He’s a Tennessee state representative and pharmacist.
The last name sounded so familiar.
It turns out that this Bobby (RFK Jr. is sometimes called Bobby too) is the son of GOP Rep. Diana Harshbarger, who is also a pharmacist. She earlier wrote RFK Jr. asking that he make the FDA unleash pop peptides. Compounding pharmacies stand to benefit financially if the PCAC recommends allowing pop peptide compounding.
With all of this in mind, should Bobby Harshbarger be a member of PCAC voting on peptides?
Regenerative medicine clinic leaders who sell peptides on PCAC
What about the other PCAC members?
Three members are listed as having regenerative medicine expertise: Asare B. Christian, Melissa Loseke, and Gerald E. Morris. As a regenerative medicine biologist, that caught my eye.
Loseke is President & CMO of Re-new Institute. Morris’ LinkedIn says he’s “specializing in Regenerative and Longevity Medicine and Certified High Performance Life coach.” He practices at the AMG Center for Regenerative Medicine and Aesthetics. Dr. Christian is “the founder of Aether Medicine in Wayne, Pennsylvania.”
Web searches and articles over at STAT and WaPo indicate that they have marketed peptides.
Other PCAC members, FDA warning
Some others on the committee are in the pharmacy industry. Others have also been associated with peptide marketing.
If PCAC now has many members associated with peptide marketing won’t they be inclined to advise the FDA to make unproven peptides available for compounding?
This from STAT highlights a recent FDA warning letter that is relevant here:
“Gabriel Alizaidy is the scientific director of Maximus, an online wellness clinic that prescribes testosterone, peptides, obesity drugs, and lab-developed tests to help people “look, feel, and perform at your absolute peak.” The telehealth company specifically prescribes compounded sermorelin and tesamorelin growth hormone peptides, which are meant to aid exercise recovery, sleep, fat loss, and boost energy.
The FDA issued a warning letter to Maximus earlier this month for marketing compounded GLP-1 products tirzepatide and semaglutide.”
I find this all quite concerning.
Given the professional activities of many PCAC members, it is reasonable to ask whether they have financial or professional interests that could be affected by FDA recommendations on peptide compounding, and if so, how those interests are being disclosed and managed through the FDA’s ethics process.
Expect FDA staff to be undercut on some peptides?
The PCAC may undercut FDA staff (the experts) who consistently have not been in favor of compounding of these peptides. These experts are still disinclined toward compounding of these unproven peptides. In the documents related to the upcoming PCAC meeting, over and over again the FDA officials caution against allowing pop peptide compounding. For example:
“On balance, the physiochemical characterization, information on historical use, lack of any evidence of effectiveness, and safety information for both TB-500 (free base) and TB-500 acetate weigh against their being added to the 503A Bulks List.”
Here’s the full list of PCAC meeting prep materials. They say evidence weighs against BPC157 and other peptides too being on the 503A list (allowing compounding).
So, what happens next? I bet that overall PCAC will disagree with the FDA scientists on peptides on more than one occasion moving forward even if some individual members disagree. Then I expect that RFK Jr.’s HHS will side with the PCAC and many unproven peptides will be made available. Compounding pharmacies and telehealth firms will profit.
Am I too skeptical?
Some may argue that those same backgrounds for PCAC members provide the practical expertise needed to evaluate complex compounding issues. I’m curious what The Niche readers think so please weigh in with comments. Maybe the PCAC will surprise me with its independence?
Weakening stem cell oversight next?
Looking further ahead, we can expect some kind of Kennedy-driven weakening of FDA oversight of regenerative medicine more broadly including stem cells.
Such softening may already be happening without any transparency. For example, it’s quite possible Kennedy has forced the FDA to exercise enforcement discretion on certain favored (but non-FDA-approved and scientifically unproven) stem cells.
Overall, whether it’s unproven peptides or stem cells, the bottom line is that good clinical trial data are needed before such things are marketed, but are generally absent. Pop peptides are much the same as any other unproven type of drug and should be treated as such by the FDA.
More coverage
From WaPo: FDA staff recommendation undercuts RFK Jr.’s push to expand peptides.
From STAT: Longevity, wellness physicians named to panel advising FDA on peptides.