The peptide saga has reached what could be its most confusing chapter — at least for consumers.
The popular — and experimental — drugs received unprecedented attention in late July during a marathon hearing held by a panel that advises the Food and Drug Administration.
The panel considered whether to back the production of seven different peptide therapies — and voted in favor of all but one — despite concerns raised by the agency's own scientists.
These peptides include some of the most sought-after injectables, BPC-157, TB-500 and MOTS-c.
But that recommendation alone doesn't change the status of these substances. It's still illegal for pharmacies in the U.S. to make these compounds.
The FDA staff and leadership now need to review the data and decide whether compounding pharmacies in the U.S. should be allowed to make any of the seven peptides the panel considered.
It's a regulatory nuance that Dr. Jessica Duncan, who spoke in favor of peptides at the FDA meeting, now finds herself explaining to patients who've seen the headlines and want to know when these therapies will be available.
"They are now even more curious," says Duncan, chief medical officer for the telehealth company IVIM Health. "We tell them that the timeline is uncertain."
What are the chances these peptides get the green light?
There's no guarantee, but it seems likely the FDA will move forward. The agency usually follows its advisory committees' recommendations.
Plus, there's high demand for these products — and Health Secretary Robert F. Kennedy Jr., whose agency oversees the FDA, has called to make them available.
Normally, the agency would move forward through its formal rulemaking process, which could take anywhere from several months to possibly over a year, says Jesse Dresser, a partner at the law firm Frier Levitt who represents compounding pharmacies and others in the industry.
"It would actually surprise me if this followed the traditional pathway of formal rulemaking," Dresser told NPR. "Whatever options exist to make this a faster process, I think they are going to be leveraged."
One likely scenario: The agency could green-light these peptides in the interim by placing them on what's known as the "Category One list."
That would give compounding pharmacies cover to begin making these products sooner, while the longer rulemaking process plays out.
"I do think that there is significant pressure here, but the FDA needs to follow the data," says Ilisa Bernstein, a former FDA official and pharmacist who's an expert on drug and pharmacy policy.
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Another route — one that would almost certainly result in a legal challenge — is that Kennedy could cite the dangers posed by the unregulated peptide market as a rationale to immediately place these on a list that OKs their compounding, says Dresser.
That authority is normally used to remove unsafe products from the market, not fast-track them. But "this is a unique scenario, unique product, unique industry and unique administration," he says.
The agency could also buck the recommendations of the panel and decide not to change the status of these peptides. That would likely result in lawsuits from the industry, says Abha Kundi, an attorney at Aaron Fox Schiff who focuses on FDA regulatory law.
Though she adds that the agency is clearly "very attuned" to dealing with the real world landscape and the current availability of these products.
"In many ways, the toothpaste is out of the tube here. I think that is absolutely part of the calculus."
Why have peptides become so controversial?
Demand for them has leapfrogged well ahead of the evidence.
They are promoted widely in the wellness and longevity space and often taken together by injection as "stacks," for injury recovery, muscle growth and fat loss, improving athletic performance, enhancing metabolism and more.
Unlike many of the GLP-1 weight-loss drugs — which are also synthetic peptides — none of the seven peptides under consideration has undergone the kind of large-scale, rigorous trials in humans that are necessary for drug approval.
But the gray market exploded several years ago, after the FDA placed many of them on a list that prohibited compounding pharmacies from making them due to safety concerns.
That dynamic has led to a dangerous situation. People are now obtaining these peptides from unvetted sources under the guise that they're only being used for "research purposes" — not for human consumption.
"The gray market space is a lot seedier than what people think," says Dr. Haleem Mohammed, chief medical officer for Gameday Men's Health, which operates health clinics that offer hormone optimization and peptides. "That's nowhere I want my patients getting their medications from."
Mohammed was one of the FDA panelists who voted in favor of these peptides. Like others in the industry, he argues that the agency's presentation during the meeting did not showcase the full breadth of evidence.
"This is not a rubber stamp," he told NPR. "This is about moving towards a regulated pathway for peptides that patients are already using."
The FDA's scientists raised numerous concerns about the lack of published human data for all seven of the peptides and recommended against allowing for their production.
Even defining each substance proved difficult because the common name for a peptide can cover many compounds with quite different chemical compositions in the scientific literature, they said.
Legitimizing these peptides for compounding doesn't require nearly the same degree of evidence as FDA drug approval, but the agency still has a "responsibility to ensure that there's some level of safety before they become widely available," explains Bernstein.
"Once the door is open, any pharmacy can compound these products," she says. "So it could have a huge presence in the marketplace."
If the FDA backs peptides, how will people get them?
These drugs will require a prescription, but you probably won't be able to pick them up from your local CVS or Walgreens anytime soon.
Instead, they'll be available from compounding pharmacies, which prepare the drugs to order rather than manufacturing them the way a pharmaceutical factory would.
And it's unlikely patients will be able to get any of these drugs immediately.
Pharmacies will need time to acquire the active ingredients so they can begin making them, says Scott Brunner, who leads the industry trade group, the Alliance for Pharmacy Compounding.
"It's going to create some chaos," he says. "It might take two months, it might take nine months, it depends on the substance."
It won't be difficult to find someone willing to prescribe them.
Major direct-to-consumer telehealth companies, med spas and high-end longevity medical practices alike are already marketing peptides and their potential.
But it's likely that many doctors practicing in traditional medical settings will be more wary of prescribing them.
Various professional organizations offer training and certifications on peptide medicine; however, there are no widely accepted, evidence-based guidelines from major medical associations on how to use them.
"I think the commercial enthusiasm is outpacing clinical science here," says Dr. Harmeet Narula, an endocrinologist at Banner Health in Arizona who regularly gets questions from his patients about peptides.
"It's important for folks to know that what happened does not mean these drugs are FDA approved."
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