| Two days’ worth of debate among FDA advisory committee members and agency staff over whether compounding pharmacies should be able to make seven different peptides left me with some big questions. |
| In a world where gray- and black-market peptides have entered the mainstream, is the committee's mandate to recommend for compounding only drugs that actually work and won’t harm patients? Or is it to recommend certain drugs because that’s potentially safer than the alternative — in this case, a market where anyone can purchase research-grade chemicals sans prescription? |
| Proponents of peptides seem to think it’s the latter. An argument that was made repeatedly by public hearing speakers and advisory committee members is that a “no” vote wouldn’t eliminate the huge demand for peptides, used today for various health, wellness and longevity goals. Rather, it would continue sending consumers to overseas suppliers of dubious quality. Allowing them to be made by compounders would help ensure patients get safer products. |
| And surprisingly, some speakers argued that the advisory committee shouldn’t even be concerned with whether a drug works. FDA staff scientists who recommended against lifting restrictions on the peptides erred when judging them through that lens, said peptide advocates during the public hearing and on the committee. Ultimately, the committee voted in favor of allowing compounding pharmacies to make six of the seven peptides under consideration. |
| After the meeting, Shawn Hodges, CEO of Revelation Pharma, a network of compounding pharmacies, explained to me that there’s fear that by weighing efficacy, the committee adopts the same thinking as it would when considering a new drug through the formal FDA approval process. Compounding pharmacies just don’t have the resources to invest in clinical studies, especially for peptides that aren’t patentable, he said. |
| Hodges is “cautiously optimistic” that the FDA will follow the advisory committee’s recommendation and allow compounding pharmacies to make the peptides. That will set off a bunch of changes in the supply chain that could improve what’s available to the masses. Right now, he hasn't seen a whole lot of peptide suppliers that stand up to the FDA’s good manufacturing practice standards. But he expects that as compounders press them to, suppliers will start to upgrade their facilities, training, quality and testing processes. |
| “It’s time to sunset the research-grade mindset,” Hodges told me. |
| But it’s tough for me to see how the FDA and its advisors could turn a blind eye to a lack of efficacy data, particularly from rigorous trials, when determining what’s allowed to be compounded. Patients look to the FDA to tell them that what’s on the market is not only not going to kill them, but will do what sellers claim. Anything less will allow snake oil to flourish. |
| - Shelby |
