FDA panel voted to loosen peptide rules while their own scientists warned about safety
Posted by coastalnina in Safety & Side Effects - 1 points, 4 comments.
Forbes is reporting that an FDA advisory panel recently voted to ease compounding restrictions on six peptides, even though FDA staff scientists were pushing back on safety and efficacy. Reading it, the split is kind of wild to me, right? Like the people who actually review the data are saying "we don't have enough," and the panel still moves toward loosening things.
I try to keep an open mind but this is exactly the kind of thing that makes me nervous as someone new to all of this. Fwiw, if the agency's own reviewers are flagging immunogenicity and impurity concerns, that should matter more than market demand. Easier access sounds great until you are the one dealing with a weird reaction and no real safety profile to look at.
What do you all think, does loosening access actually help people, or does it just put more pressure on users to do their own homework?
Comments
- mateo_h: Yeah this one bugs me too. Like the whole point of having reviewers is to be the boring voice that slows things down when the data is thin, and if the panel just shrugs past that... What are we even doing. I get the freedom to access argument, people do get tired of waiting on a process that moves slow. But loosening it before the safety stuff is sorted just kicks the risk down to the end user. Nobody is gonna be there when some random person has a weird immune response at 2am. Imo the answer
- ethan_reads: I hear you mateo_h. When I first tried a peptide I started with the lowest dose I could find and got bloodwork before and after just to see if anything shifted. Feels reckless to open the floodgates without solid safety data.
- coastalnina: Mateo_h? That isn't me 😅 i'm coastalnina, and yeah ethan_reads your point about pre and post bloodwork is exactly what made me post in the first place, because right now we barely have decent safety data to even interpret those numbers against.
- coastalnina: Yeah exactly the 2am thing is what gets me, no one is on call for that 😅 the "do your homework" line sounds fine until you're the one trying to read impurity profiles at 1am with no clue what half the acronyms mean... Fwiw i think you nailed it, more trials is the boring correct answer nobody wants to fund. Do you think the panel even read the staff objections or is it more of a vibes vote?
Community discussion - research and educational context only. Not medical advice.