FDA panel with peptide industry ties votes to ease BPC-157, TB-500 restrictions
Posted by tiredmira in Safety & Side Effects - 1 points, 2 comments.
This NBC piece covers the recent FDA Pharmacy Compounding Advisory Committee vote, where four peptides got the green light to be compounded: BPC-157, KPV, TB-500 and MOTS-c. The other three, including emideltide and semax, got reviewed the next day.
What bothers me is the conflict of interest angle here. Panel members with ties to the peptide industry basically said the safety concerns don't matter much, and that's a huge problem when we're talking about substances with thin human safety data. Compounding pharmacies already operate with way less oversight than I'd like for something I'm injecting.
I get that patients want access and telehealth clinics have basically forced the FDA's hand by prescribing these things anyway. But I'd rather see real trials first. How does everyone else feel about this? Are you gonna be more comfortable using compounded BPC-157 after this vote, or are you sticking with research suppliers?
Comments
- shay_hrv: Ngl the conflict of interest thing is what jumps out to me too. When a panel with industry ties is voting on safety of stuff that already has thin human data, that's a yellow flag regardless of how the vote goes. I'm not gonna be more comfortable just because of this. Compounding pharmacies do have less oversight than 503B outsourcing facilities, and "expert panel said it's probably fine" isn't the same as a real safety trial. For me, the bar stays the same. Real human data, not votes. Also ki
- tiredmira: Yeah exactly, "expert panel said it's probably fine" is doing a lot of heavy lifting there 😅 The 503B vs regular compounding distinction is a good callout, I didn't dig into that angle much. For me the bar hasn't moved either, basically I still want to see actual PK data and longer term safety stuff before I'm comfortable injecting any of these regularly. The telehealth forcing their hand part is what I keep coming back to though, feels like the FDA is reacting to market pressure instead of l
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