What did the committee decide?
BP-157, a synthetic 15-amino acid peptide sometimes used to treat ulcerative colitis, and KPV, which is used for inflammatory conditions, were the first peptides considered on July 23 for addition to the 503A bulks list. Both were approved.
On BP-157, eight members of the committee voted yes, six voted no, and one abstained. The “yes” votes were largely from committee members who represent or advise telehealth companies, which broadly stand to benefit financially from the widespread adoption of peptides. Many of the people who voted “yes” said they wanted compounding pharmacies to dispense peptides because the alternative—patients getting the drug in the gray market—was worse.
“As a physician, I have to make sure that I’m keeping patients as safe as possible. That’s my mandate, right? Do no harm,” said Dr. Haleem Mohammed, chief medical officer of Gameday Men’s Health, a telehealth firm, during the hearing. “So when I look at something like saying no to this and pushing it to the gray market, am I doing greater harm? And that’s why I lose sleep at night.”