FDA panel votes to ease access on 6 of 7 peptides, but its not a done deal yet
Posted by priya_fasted in Research & News - 1 points, 4 comments.
PBS is reporting that an FDA advisory panel just voted to recommend loosening restrictions on six out of seven peptides they reviewed. The split inside the agency is the interesting part, because the career scientists there are saying there isnt enough data to back making these more widely available, while the panel itself went the other direction on most of them.
Im honestly torn on this. On one hand I get the safety argument, and I dont want pharmacies churning out stuff that hasnt been properly studied. On the other hand, a lot of these compounds have been used for years and theres a real market of people who feel like the approval process is just too slow. The black market piece in result 6 kind of proves that point whether anyone wants to admit it or not.
The question I keep coming back to is whether loosening compounding rules actually fixes the safety problem, or just moves it from one place to another. Curious what others here think.
Comments
- runner_aaron: Tbh I keep landing on the same thought. Loosening compounding rules doesnt really fix safety, it just shifts who is liable and where the supply comes from. What I want to know is what the split was actually based on. Was the panel looking at clinical data or at how many people are already sourcing these on their own and having issues? Because those are two very different conversations. If its the second one then the FDA is basically reacting to the black market instead of doing proper review.
- nora659: Yeah that liability piece is what sticks with me too, like it feels more like a paperwork shuffle than anything that actually protects anyone. And good call on the split, if the panel was leaning on real world use reports from telehealth and grey market stuff then yeah thats basically policy catching up to what people are already doing, not some fresh safety review. I havent seen the actual list yet either but im curious which one got left out, that one probably has the most interesting story be
- priya_fasted: Honestly yeah, the paperwork shuffle framing is kind of what bugged me too. And on which one got left out, I wanna look into that because my guess is it was one where the safety signal was actually a red flag and not just incomplete data. If its a thrombotic risk or something cardio then the panel holding the line makes a lot more sense than them just being cautious for the sake of it.
- priya_fasted: Yeah the liability question is exactly what bugs me too. PBS didnt name the six that made it in their writeup i dont think, or at least i didnt catch it. Ill go dig for the actual FDA press release and the panel roster to see who voted what. If the panel was looking at patient self reporting from surveys thats a very different thing than RCT data. Also kinda curious if any of the six are ones people on here actually use, would make the conversation a lot more grounded. Ill post back when i find
Community discussion - research and educational context only. Not medical advice.