Rfk Jr. Promised To Stop The ‘aggressive Suppression’ Of These Controversial Drugs. He’s Making Progress.

Robert F. Kennedy Jr. swears by them. Make America Healthy Again influencers say they can do everything from heal torn tendons to help drop dress sizes.

But Food and Drug Administration drug reviewers warn there’s insufficient evidence that certain peptides — amino acids that increasing numbers of Americans are buying on the unregulated market and injecting into their bodies — provide those benefits without also causing harm.

This week, Kennedy, who came into his job as Health secretary promising to stop the FDA’s “aggressive suppression” of peptides, took a big step toward potentially reversing the agency’s position.

During a two-day meeting that ends Friday, an advisory committee of his appointees largely ignored FDA staffers’ advice and recommended the agency allow specialized “compounding” pharmacies to make several peptides for customers with prescriptions. The split but favorable votes for most of the chemicals under consideration prompted loud cheers and applause from peptide supporters who attended the meeting in person and dominated the meeting’s public comment sessions.

If Kennedy grants final approval, it would mark a major lobbying victory for the pharmacies and telehealth firms already gearing up to offer prescriptions and the wellness influencers on social media touting peptides as cure-alls — and a big loss for the FDA’s safety and efficacy analysts.

Peptide proponents say patients are now taking risks by buying them from unregulated manufacturers, a concern they say would go away if the FDA allowed licensed pharmacies to craft them under state and federal guidelines. They pointed to the already burgeoning market for the unregulated versions — ads for them have taken over Instagram and TikTok — as reason enough for FDA to give the green light.

“I'm going to continue using it,” Mike Stone, a self-described “gray market” peptide supplier, told the panel. “I gave myself an injection this morning. I believe in it, and I'm going to get it by whichever means possible.”

Peptide critics say Kennedy stacked the deck. The committee roster contained several new permanent members who would benefit from loosened restrictions, though several others given temporary seats had academic backgrounds.

The Pharmacy Compounding Advisory Committee’s recommendations aren’t binding, leaving the FDA free to consider them while ultimately making its own call on the peptides’ status. Ultimately, the decision is Kennedy’s. Though it would be highly unusual, he has the power to overrule the agency decisions.

Those who want the FDA’s blessing say consumer demand will remain high regardless of its decision — and the unknowns associated with the booming gray market of research-grade chemicals.

“This is Uber versus taxis, and I think industry knows Uber is going to prevail,” said Brigham Buhler, a Kennedy ally who owns a compounding pharmacy and a wellness clinic.

An existential inflection point?

The advisory meeting comes nearly three years after the FDA reclassified more than a dozen peptides to a category of substances considered potentially unsafe on its so-called bulks list for compounded drug ingredients. That made them illegal for specialized pharmacies to make.

Many peptide supporters acknowledge the evidence supporting the substances under consideration is thin and doesn’t represent population-level data. But they say the small studies and anecdotes point toward great potential for individual patients — and that the peptides should be available for them via health care providers who can prescribe them based on a person’s specific needs.

“The premise of compounding is to have an interaction between the patient and the health care provider, which results in an individual prescription,” Lee Rosebush, a pharmacist and lawyer who leads the American Academy of Peptide Medicine, told the committee Thursday. “The prescribed treatment is geared for them — not the masses or, in that perspective, an unknown patient.”

But critics say that’s exactly what will happen if the FDA permits domestic compounding pharmacies to manufacture the peptides.

Major telehealth platforms like Hims and Noom — which boomed during the GLP-1 weight-loss drug shortage earlier this decade — have already signaled plans to enter the market should regulators sign off. And while the agency evaluates seven peptides for specific conditions, adding them to the bulk ingredient list for compounders wouldn’t limit their potential treatment uses or how they’re manufactured — whether as injectables, nasal sprays or other methods.

“The system was not set up for the mass compounding that’s going to be coming,” former FDA official Ilisa Bernstein told POLITICO.

Consumer advocates and the brand-name pharmaceutical industry also argue that allowing peptide compounding would undercut market incentives for companies to spend years and hundreds of millions of dollars to research and develop drugs that could eventually be taken through the formal FDA review process.

Permitting peptide compounding “would create a wide bypass for FDA clinical trial and approval requirements,” said Michael Stepanovic, a pharmacist on the board of the Collaborative for Evidence-Based Medicines, which recently launched to oppose “mass-marketed, unapproved compounded drugs.”

MAHA influence

When the FDA launched the reconsideration process for seven peptides in April, Kennedy promised that “independent experts will rigorously evaluate each substance on its scientific merits using full clinical, pharmacological, and safety evidence.”

But in the same X post, Kennedy claimed the FDA’s moves would begin “to restore regulated access and will immediately begin shifting demand away from the black market.”

The advisory committee’s first vote — recommending that BPC-157, which is often marketed for gut healing and tissue repair, be listed for compounding — broke along the lines of when members were appointed. The eight whose terms began in April and May — most of whom critics have argued have conflicts of interest favoring broader peptide availability — all voted to recommend BPC-157 and other popular wellness and longevity substances, while the few longtime participants and temporary members with academic backgrounds opposed or abstained.

Ahead of the meeting, Rosebush’s group suggested the FDA’s briefing materials — posted online on June 29 — were incomplete, relying on old information rather than new quality and manufacturing data it submitted to the agency earlier this month. The committee’s newly appointed permanent members peppered FDA staff with questions about how they reached their assessments against the peptides and whether the new information will ultimately factor into the agency’s proposal.

Agency officials said all information submitted by the FDA’s comment deadline will be considered before it makes a final decision, adding that the American Academy of Peptide Medicine’s data is publicly available on the docket. “At the time we did the assessment, that's all I had,” said Russell Wesdyk of the FDA’s Office of Pharmaceutical Quality, noting the volume of information staff had to analyze ahead of the meeting.

Some peptide proponents proposed new oversight mechanisms to accompany broader peptide compounding to assuage those worries. But FDA officials cautioned that the agency has limited authority to set such parameters once an ingredient is placed on the list.

“I don't have any guardrails to apply,” Wesdyk said.

Both sides of the debate invoked patient safety — from gray-market sources and from potential side effects or drug interactions — as a key reason for members to vote in either direction.

Bernstein worked at the FDA in the aftermath of a deadly 2012 meningitis outbreak tied to a compounding facility. She said she fears such a disaster could happen again, despite stricter industry oversight requirements that were instituted in response — and under which pharmacies operated during the weight-loss drug shortage that popularized mass compounding.

“We need to make sure the lessons learned continue to be part of that conversation,” Bernstein said. “The risks are still there.”