The Market Is Not a Clinical Trial

I have spent much of the past year warning that the peptide industry was running an experiment on the American public.

Last week, the experiment took a big step toward being legitimized.

On Thursday and Friday, the FDA’s Pharmacy Compounding Advisory Committee convened to consider whether seven unapproved experimental “peptides” should be added to the 503A Bulks List, which would allow traditional compounding pharmacies to prepare them for patients with prescriptions. The committee narrowly voted to recommend adding six: BPC-157, KPV, TB-500, MOTS-c, epitalon, and semax.

Before the meeting, the FDA’s own scientists had recommended against adding every one of them.

That should have been the end of the discussion. FDA staff reviewed the available evidence and found the same thing that anyone who has spent five minutes seriously examining the peptide market already knows: fantastical claims, enormous consumer interest, and painfully little credible human data demonstrating safety or efficacy.

The committee voted yes anyway.

I have watched some ridiculous things happen in American healthcare, but these hearings deserve a special place in the history books.

This was a federal advisory committee discussing whether experimental substances should receive a legitimate pathway into American pharmacies. The people arguing for access repeatedly acknowledged the lack of evidence, the unanswered safety questions, and the poor quality of products currently circulating online. They then used those failures to justify expanded access.

The market had already made peptides popular, they argued. Consumers were already buying them. The gray market was already dangerous. Licensed compounding pharmacies could produce them more safely.

Therefore, pharmacies should be allowed to compound them.

That reasoning is completely backwards.

The fact that people are buying unapproved substances from dubious websites does not establish a medical need. It proves that the FDA has failed to enforce its own rules. The appropriate response to a dangerous gray market is to address the dangerous gray market. It is not to move the same experimental substances behind a pharmacy counter and hope the white coat makes everything respectable.

A licensed pharmacy may be able to manufacture a cleaner vial than a research-chemical company in China. That is a manufacturing argument. It tells us nothing about whether the substance inside the vial is safe, effective, or medically useful.

Clean poison is still poison. Sterile uncertainty is still uncertainty.

During the hearing, Dr. Anant Vinjamoori, the Chief Medical Officer of Hims & Hers, described receiving a photograph of peptides being sold in a Queens bodega. He presented this as evidence of the alternative consumers face if legitimate pharmacies are prevented from compounding them.

I am a New York City pharmacist. I am generally opposed to taking medical policy cues from the inventory decisions of bodegas.

Hims also happens to operate one of the largest direct-to-consumer telehealth platforms in the country. It has an obvious commercial interest in the creation of a lawful, scalable peptide market. So do many of the businesses, clinics, and practitioners that advocated for these substances during the hearings.

To be clear, that does not automatically make their arguments wrong. But it does mean their arguments should have faced extraordinary scrutiny. Instead, commercial demand was treated like a form of clinical evidence.

Dr. Haleem Mohammed, Chief Medical Officer of Gameday Men’s Health, voted in favor of recommending multiple peptides. I’m sure I don’t have to explain that “Gameday Men’s Health” advertises peptide sales on its homepage. He explained that denying access could push patients toward the gray market and cause greater harm. He also invoked “medical freedom,” language that has become increasingly popular among peptide advocates.

Medical freedom is an appealing slogan because it allows everyone to hear whatever they want.

Patients hear autonomy. Doctors hear discretion. Businesses hear a large and lightly regulated market.

Freedom, however, does not erase the obligation to produce evidence. A patient can choose among treatments, decline treatment, or accept greater risk after being properly informed. Those choices still depend on having some reliable understanding of what a substance does. With many of these peptides, the basic information necessary for meaningful consent barely exists.

You cannot consent to a risk that nobody has adequately measured. You cannot weigh benefits that have never been convincingly demonstrated.

The committee was not being asked to approve these peptides as drugs, and several members leaned heavily on that distinction. They argued that the standard for inclusion on the compounding list should differ from the standard used for formal FDA approval.

Legally, that is true. Scientifically, it is a convenient dodge.

Compounding exists to meet the needs of patients who cannot use commercially available, FDA-approved products. A pharmacist might prepare a liquid version of a medication for a child who cannot swallow a tablet. We might remove an inactive ingredient to which a patient is allergic. The practice is supposed to provide customized versions of medicines whose therapeutic value is already understood.

The 503A Bulks List offers a pathway for certain substances without an applicable USP monograph or an FDA-approved drug product. That pathway was never supposed to become a side entrance through which entire categories of speculative medicine could avoid the drug-approval process.

That is what makes these hearings so consequential. Peptide advocates are attempting to turn an exception designed for individualized patient care into a business model for mass-market experimentation.

The evidence did not change last week. The people evaluating it did.

Earlier this month, I wrote about the composition of this committee after the FDA replaced several members and appointed a group containing extensive ties to compounding, telehealth, wellness medicine, and the peptide business. A majority of the newly appointed members had clear connections to companies that sell, promote, prescribe, or stand to benefit from expanded access to peptides.

I asked who would watch the watchmen.

We now have the answer. Apparently, nobody.

An advisory committee does not need to be filled entirely with disinterested monks. Relevant professional experience matters, and experts will often have industry relationships. But there is a difference between consulting someone who understands a market and allowing people positioned to profit from that market to help decide whether it should exist.

The FDA’s career scientists reviewed each substance and recommended against inclusion. For BPC-157, the committee voted 8-6 in favor, with one abstention. KPV and TB-500 received similarly divided support. MOTS-c passed 7-5. The following day, the committee also recommended epitalon and semax. It rejected only emideltide, and even that vote was close.

Six experimental peptides advanced despite the objections of the agency’s own scientific staff.

We should be honest about what happened. This committee did not discover new clinical evidence. It did not resolve the unanswered questions surrounding long-term safety, dosing, drug interactions, purity, immunogenicity, or effectiveness. It decided that those questions mattered less than access. And the official recommendation was approved along partisan lines in every instance.

The market created the demand. Influencers, wellness clinics, telehealth companies, and podcast personalities spent years promoting peptides as shortcuts to faster recovery, better sleep, weight loss, improved cognition, lower inflammation, and slower aging. Consumers began buying them. Businesses formed to serve those consumers. The businesses then pointed to the size of the market as evidence that regulators needed to accommodate it.

That is a spectacular regulatory incentive.

If this logic holds, a company no longer needs to prove that an experimental substance works. It needs to generate enough hype that enforcement becomes inconvenient. Build the websites. Recruit the influencers. Encourage an online community of self-experimenters. Allow a black market to flourish. Then arrive in Washington and argue that legalization is the only responsible way to protect the customers you helped create.

The market is extraordinarily good at discovering what people will buy.

It cannot tell us whether those products are medicine.

In the spirit of fairness, I will acknowledge that there is a serious counterargument here. Peptides are already widely available, prohibition has failed, and consumers purchasing vials labeled “for research use only” face obvious risks. Bringing production into licensed pharmacies could improve product quality and give patients access to clinicians who can monitor them.

I understand the appeal. I also think it ignores what happens when a pharmacy dispenses a product.

Pharmacies confer legitimacy. So do prescriptions. Most patients reasonably assume that a medication prescribed by a doctor and prepared by a licensed pharmacist has passed some meaningful test of medical value. Very few will understand the legal difference between an FDA-approved drug and a substance permitted for compounding through the 503A Bulks List.

The peptide industry understands that confusion perfectly well. It is the whole prize.

Once these products can be prescribed and compounded openly, the gray market will not disappear. It will gain a respectable sibling. Telehealth companies will advertise access. Wellness clinics will create protocols and packages. Social media will fill with before-and-after photographs and discount codes. The words “pharmacy compounded” will appear in large type, while “not FDA approved” sits somewhere near the bottom of the page in a font designed for ants.

We have already seen this movie with compounded GLP-1 drugs. The peptide sequel will have weaker evidence, broader claims, and fewer limits on the imagination of the people selling it.

I do want to clarify that despite the media headlines, none of this means the committee has legalized these six peptides. Its recommendations are nonbinding. The FDA still has the final decision, and adding the substances to the 503A Bulks List would require further agency action through the rulemaking process. Until then, the committee’s vote is a recommendation.

The FDA can reject it.

Its own scientists have already provided ample justification. They examined the available evidence and concluded that these substances did not belong on the list. The agency does not need another podcast anecdote, patient testimonial, or photograph of a peptide display in Queens. It needs the institutional courage to follow the science its employees presented.

I wish I had more confidence that it will.

The committee did not assemble itself. Its new members were selected under an administration whose health secretary, RFK Jr, has publicly supported wider access to peptides and has made “medical freedom” a central part of his health agenda. The commercial and political forces that influenced these hearings will also be present when the FDA considers what to do next.

If the agency accepts the recommendations, responsibility will belong to the FDA. It will not be able to hide behind an advisory committee while disregarding the warnings of its own scientists. It will have chosen to create a legitimate commercial pathway for experimental substances whose popularity has raced far ahead of the evidence.

That decision would extend well beyond BPC-157 or TB-500. It would establish a new model for American medicine, one in which consumer demand can overpower scientific uncertainty, commercial interests can help shape the bodies judging their products, and regulators can redefine surrender as harm reduction.

We used to ask companies to prove that a drug worked before allowing them to build a medical market around it.

Now the market comes first. The evidence can catch up later.

The market has already voted. It wants peptides.

The FDA’s job is to decide whether they consider that medicine.

Alec Wade Ginsberg, PharmD, RPh
4th-Gen Pharmacist | Owner & COO, C.O. Bigelow
Founder, Drugstore Cowboy