By Philip J. Schneider and Ronald P. Jordan
Patients deserve innovation, but they also deserve evidence. FDA should not allow pharmacy compound-ing to become a shortcut around safety and efficacy standards that protect the public. If compounding becomes an entry point for every substance that attracts an on-line following, the distinction between individualized patient care and mass production of unapproved, untested drugs begins to disappear.
The outcome of the FDA’s recent Pharmacy Compounding Advisory Committee (PCAC) meeting is about far more than a handful of peptides. It is about whether the country still has a functioning line between regulated medicine and unaccountable experimentation. At stake is whether pharmacy compounding will be reined back in as the narrow pathway for individual patient care it was designed to be — or whether the mass compounding of GLP-1s becomes the template, with peptides opening the next front in a scalable commercial pathway for selling experimental drugs that have never demonstrated they are safe or effective.