So-called wellness peptides are even more in the spotlight this week as the pharmacy compounding advisory committee or PCAC launches a series of meetings to evaluate restoration of compounding of these unproven peptide drugs.
This committee is supposed to take FDA staff guidance into consideration as it decides what to recommend to the agency. Typically it would vote on the slate of peptides in question at the end of each meeting. One would hope such an ad comm would focus on data.
However, there’s reason to think this PCAC will more follow RFK Jr. and corporate profits than FDA experts. I see major potential conflicts of interest that apparently remain unresolved.
Rubber stamp?
Why might PCAC just rubber stamp most of the popular peptide compounding?
There are several reasons.
As a peptide user himself, RFK Jr. wants to “free the peptides.” His HHS reportedly helped to put together this PCAC too. Very few members seem to have been selected by the FDA itself.
While those few PCAC members appointed by career staff and not tied to the peptide/compounding/health industry might vote for appropriate caution, I think RFK will win the day.
FDA staff voiced clear concerns about compounding of these unproven peptides. For example, if you read the meeting materials, the FDA indicated that the weight of evidence is against allowing peptide compounding.
PCAC potential COIs, but no waivers
There’s another key reason to think this PCAC may advise the FDA to allow compounding.
In my view, the committee has many members who potentially stand to gain financially if pop peptide compounding is eventually permitted. There seem to be at least potential conflicts of interest there, right? In fact, news and science outlets like the bmj reported that at least seven PCAC members have a track record of selling these kinds of peptides. Other committee members are pharmacy and compounding folks, members of an industry that stands to gain if it can compound these peptides again. How can these members be impartial? It seems like a big challenge to me. From the bmj:
“Emily Hilliard, press secretary at the Department of Health and Human Services, which oversees the FDA, said: “All committee members underwent the same ethics review and vetting process required of all FDA advisory committee members. Candidates that could not meet existing ethics requirements were removed from consideration. FDA is committed to robust, transparent discussions about the products it regulates to ensure Americans can make informed decisions about their health.”
How exactly was this vetting done given the PCAC roster? Maybe all the PCAC members who previously were linked to peptide marketing will no longer have anything to do with these peptides?
To be clear, the FDA can still have people with potential COIs serve on ad comms, but a waiver is required. So, maybe a bunch of the PCAC members have waivers?
I asked the FDA about waivers related to potential COIs on this PCAC and what FDA/HHS have done to address the potential COI issue. Remarkably, the FDA replied to indicate that there are no COI waivers for the PCAC for these meetings. How is that possible? I see this as further evidence of Kennedy stacking the deck on peptides.
Update: a group of temporary new PCAC members, maybe with fewer peptides ties
Since this post went live, I saw that the FDA put up a new PCAC roster with a group of temporary but voting PCAC members in addition to the original group of non-temporary PCAC members. I need to read up on these new 8 members, but off-hand they look more like people from the academic sphere who don’t market peptides.
I also see in this new roster that they have specified more which members will be involved in which discussions/votes. Maybe those PCAC members selling peptides will only vote on peptides that they don’t sell?
Prediction: FDA follows PCAC’s lead, goes against its own experts
Let’s assume that the PCAC will recommend that the FDA allows compounding of nearly all of these peptides. Maybe with a few dissenters (see update above), but the majority is at least slightly in favor.
What happens next?
Eventually, FDA leadership probably then goes along with the PCAC and against its own agency experts. That’s bad for agency morale. It’s a negative public health move too. But the relevant leaders (FDA Commissioner and CDER Director) don’t want to upset Kennedy, right? He’s telegraphed the outcome he wants.
It won’t be too long after this series of PCAC meetings (they extend into early next year), before some compounding pharmacies and telehealth firms (sometimes one in the same) start dispensing the peptides in question (BPC-157, Ipamorelin, GHK, etc.) as some are likely to jump the gun before formal listing of the peptides for compounding. Money starts rolling in for them.
The big peptide mess likely to come
Why am I so concerned about this?
If the FDA allows compounding of these unproven peptide drugs, it is like a seal of approval in a way. It’s likely to spur even more peptide use among the public, many of whom may just think that peptides in general (like GLP-1’s) are great stuff.
Realistically, this unleashed compounding might only make a small-to-medium-sized dent at first in the peptide gray market, where you can get these drugs with little oversight. However, as I’ve predicted, I think we’ll see FDA/HHS take a swing directly at the peptide gray market with some kind of high-profile action. As I’ve also written before, we might already have seen the first sign of this with a peptide-related indictment. If the feds take major action against the gray market, that could further help the compounding industry.
The gray market is not going to just go away, though. Its peptides, often imported from China, are cheap and effectively customers don’t have to worry about a prescription (even if that’s technically illegal). Admittedly, US compounders can make peptides that have fewer contaminants and higher purity than what’s in most gray market vials. However, that doesn’t address safety issues inherent to the peptides themselves, no matter how pure they are.
I bet we’re going to see far more stem cell clinic-type firms offering both unproven stem cells and peptides. I’m already seeing this. They want to cash in on peptides too.
The bottom line is that more people will be hurt by these sketchy peptides. Tens or hundreds of millions of dollars will be wasted. In the process, the FDA’s authority will be weakened further too.