Next month, the Food and Drug Administration committee will consider easing restrictions on some peptides. Some influencers have claimed these injectables improve muscle growth, create better immune function and slow aging, among other things. However, there is very little evidence to support the benefits of many of these drugs in humans. At the same time, prescription peptides that are already on the market, such as GLP-1s like Ozempic, have seen increasing demand for off-label use.
Daniel Hartung is a professor of pharmacy at Oregon State University. He joins us to share more on the FDA processes and off-label prescriptions.
Note: The following transcript was transcribed digitally and validated for accuracy, readability and formatting by an OPB volunteer.
Dave Miller: From the Gert Boyle Studio at OPB this is Think Out Loud. I’m Dave Miller. Next month, a Food and Drug Administration Committee will consider easing restrictions on some peptide drugs. Some influencers and Health and Human Services Secretary RFK Jr. have claimed these injectables improve muscle growth, create better immune function, and slow aging, among other things. However, there is very little evidence to support these claims, and just three years ago, the FDA found that compounding pharmacies could not dispense 19 of these drugs because they’re too dangerous. Dan Hartung is a professor of pharmacy at Oregon State University. He joins us now with more details about the FDA. It’s great to have you back on the show.
Dan Hartung: Hi, good to be back.
Miller: So this FDA committee is going to be looking specifically at what drugs can be dispensed by compounding pharmacies. What are compounding pharmacies?
Hartung: Yes, so compounding pharmacies kind of play a small but important role in delivering prescription drugs for patients who may have specialty needs in terms of the way they’re administered, specific doses of drugs, just making sure that chemicals and drugs that are out there can be given to patients in ways that may not be available from traditional manufactured drugs from pharmaceutical companies.
Miller: So these compounding pharmacies have to do their own processing to various drugs that have been approved by the FDA but are not available in the kind of forms that patients might need?
Hartung: Correct, so yes, they’ll oftentimes purchase raw chemicals from approved bulk suppliers, or approved pharmaceuticals, and transform them into different types of formulations: making some things injectable, they could be topical formulations for certain patients, things of that nature.
Miller: What are peptide drugs? They’ve been around for a while, as I understand it, but they’ve gotten a lot more attention in recent years.
Hartung: Sure. Peptides are just simply kind of small chains of amino acids, which are kind of the building blocks of proteins in the body, and they serve a variety of purposes in the body to signal different processes. And there have been a variety of peptides that have been developed by pharmaceutical companies and turned into prescribed drugs that we know and use all the time, things like insulin. And then now in the last five years, some of the newer and increasingly used GLP-1 agonists are peptides as well. A lot of times they need to be injected because they’re larger molecules and they don’t do well when taken orally, so they’ll have to be injected most of the time.
Miller: I know that you don’t focus specifically on these particular peptide drugs that the FDA is going to be considering in the coming weeks, but in a general way, why did the FDA categorize 19 peptide drugs as too unsafe for compounders back in 2023?
Hartung: Right, so my sense of that, and my read of the kind of understanding of what the FDA did at that time was that there was concern that these products weren’t approved FDA drugs per se, developed by traditional drug companies, they were both products that there are concerns about immunogenicity and in fact efficacy and safety of these molecules, and so, I think it was kind of surrounding those issues about are they doing anything or are they essentially safe for patients?
Miller: One of the basic arguments I’ve seen from some of the companies who are making these peptide drugs is basically this: People are getting these on the gray market anyway, so you might as well give us the ability to sell these legally because compounding pharmacies at least are regulated and they’ve got better safety practices than just some random fly by night internet operation. What do you think of that argument?
Hartung: I think that there is some merit to that in terms of, people are sourcing these products from all sorts of different manufacturers overseas and there’s even less clarity and certainty about the potency and safety of those products, and that allowing compounders to access bulk products through more regulated sources does potentially improve the safety of it.
You can also read the alternative interpretation of that is that if some of these compounders are in fact pretty large businesses and it could accelerate the adoption of use of many of these peptides and frankly, a lot of these things we still don’t know what their efficacy or long term or even short or long term safety is, so it could just continue to accelerate their use in the population when we really don’t have good information and good evidence about what these things are actually doing for some of these agents.
Miller: I want to hear more about the standard process for actually getting regular FDA approval, but just to stick on the gray market piece for a second because this has confused me. How is it that people can get seemingly easy access to these injectable drugs — and we’re not talking here about supplements, we’re talking about drug injections. How can people get them if they haven’t gotten FDA approval?
Hartung: I think that many of these products are available and they’re kind of termed like research grade chemicals or compounds that if you are a lab and you are sensibly conducting research on these particular compounds you can access them, and that’s not within the purview, per se, of the FDA. And so a lot of it is kind of under that, and I don’t have a big presence online in various online communities that are offering channels to obtain these compounds, but I think a lot of it is coming in terms of research grade products that aren’t meant to be used kind of therapeutically.
Miller: So what is the standard process that drug makers have to go through before their products can get actual approval by the FDA?
Hartung: Right, so the FDA has set a bar historically that drug companies need to submit evidence of safety and efficacy before they’re approved by the agency and typically, historically, it’s been two controlled studies to demonstrate essentially that it meets that standard. Yeah.
Miller: How long might that take and how much money might it cost to meet that standard?
Hartung: Yeah, so that’s been a big question that’s been debated, how much does it take to bring a drug to market and some of the recent estimates that I’ve seen show that it could take in the upper hundreds of millions of dollars to a billion dollars to commercialize a drug. And I think, over the last decade or so, there’s been a push to bring more breakthrough therapies to market.
Some of those standards of efficacy and safety have been eroded a little bit. And many drugs now are brought to market with maybe only one controlled study. When I mean a controlled study, I mean, a study that randomizes patients to the investigational drug versus either placebo or what the standard of care is for that condition.
Miller: I’m talking with Dan Hartung right now. He is a professor of pharmacy at Oregon State University. Pharmaceutical companies have been directly marketing to potential customers for decades. If you spend any time watching broadcast television these days or for years now, it’s hard to get through any single commercial break without at least one ad watching happy images of people skipping around picnics or beaches and then ending by asking you to ask your doctor about something or other. How different are social media influencers with ties to non-approved compounds?
Hartung: No, that’s a great question and I think that that is really to some extent the wild west of how the FDA is reviewing kind of promotional material, both for approved and unapproved products. There have been, in the last, again, probably decade or so, there have been some lawsuits that have circulated through the court system that make promotion a little bit more permissive on the kind of First Amendment free speech grounds. So I think that companies and providers of both pharmaceuticals developed by drug companies as well as those vendors of some of these peptides may have a little bit more leeway in terms of promotion of these products on First Amendment free speech grounds.
Miller: Where does this leave pharmacists themselves, and it seems like you’re sort of caught between these two different pushes. On the one hand, patients who are saying we want these things and if we can’t get them from you, we might get them from other ways. Doctors who are doing all prescribing, sometimes off label, sometimes obviously on label. I’m just curious what this means for the practice of pharmacy.
Hartung: Yeah, I think that in terms of when you’re having conversations with your doctor or other clinician about different therapies that you’re considering to treat your condition it’s important to kind of always consider what the evidence is, that this product or this therapy, it will actually improve the condition you’re interested in taking and treating and what the safety is. And so for products that are either pharmaceutical grade drugs that you get from your pharmacy, or these online peptides, there’s kind of a slippery slope of both the evidence standard in terms of efficacy and certainly safety. If you’re sourcing peptides from research grade, freeze dried peptides out of China, I’d be real concerned about injecting those things in your body without some sort of quality assurance process for those particular products.
Miller: Have you seen a decrease in trust of pharmacists of your profession in the same way that I feel like we have seen a drop in faith in a lot of institutions that are part of the fabric of our lives?
Hartung: No, that’s a great point, and we could probably have another session about, I think that there’s quite a bit of a crisis in the pharmacy community right now in terms of pharmacies are under just enormous pressure to fill prescriptions for patients. And then also there’s been closures of pharmacies with a lot of the business practices of PBMs and things like that, that have put increasing pressure on pharmacies.
And I think that trickles down to the relationship between pharmacists and patients, and that pharmacists and pharmacies are under increasing stress and unable to provide the services that they once did to their patient populations. And I think, historically, you’ve looked at these trust surveys of who people trust in their community and pharmacy has always seemed to be high on those lists and I think we’ve taken that for granted and I think some of the business practices that have occurred in pharmacy may have led to an erosion of that trust.
Miller: Dan, thanks very much.
Hartung: You’re welcome.
Miller: Dan Hartung is a professor of pharmacy at Oregon State University.
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