Harshbarger asks for peptide enforcement discretion

Rep. Diana Harshbarger's office this week sent a letter to the FDA that, if you're interested in peptides, you gotta read.

It asks the agency to use its enforcement discretion and allow pharmacies to compound using certain peptide APIs until they could be reevaluated by the Pharmacy Compounding Advisory Committee using updated criteria.

Harshbarger’s argument — one made by both APC and, recently, Senator Tommy Tuberville (AL) — is that the FDA should focus on safety data, not efficacy data, to determine if a particular API can be used in compounded preparations. If it’s safe, let prescribers use their judgment to prescribe it and determine if it’s effective for their patient.  

For the time being, though, these peptides do not meet the criteria for compounding. We’ll of course keep you updated if (when?) this changes. Anyhow, we're grateful to Congresswoman Harshbarger for her support of this important issue.