I read two articles today that made me wonder what the next year will look like for enforcement activity in the compounding arena. First was an article by Peter Pitts published in RealClear Health (here) titled “The Compounding Loophole Has Become a Business Model”. The second is a report in the Pink Sheet written by Sue Sutter titled “Ex-Justice Department Official Clint Narver Takes Over US FDA Compounding Compliance Office” (here, subscription required). Both articles seem to point to a potential increase in enforcement activity for compounding pharmacies under 503A and outsourcing pharmacies under 503B of the Act.
Putting the issue regarding drug shortages aside, Pitts also discusses the recent public meeting and advisory committee meeting regarding whether certain peptides should be made available for compounding by 503B outsourcing facilities. It will be interesting to see how the FDA ultimately approaches this issue, particularly in light of the August appointment of Clint Narver, whose background may suggest a more enforcement-oriented approach.
But the bigger picture may be how the FDA handles compounding in general due to the position that Secretary Kennedy appears to favor at least regarding the peptide issue. How will the guardrails for prescription drug compounding and FDA regulatory enforcement authority ultimately play out? How will the Agency respond to the requirement that copies of approved products should not be compounded unless there is a bona fide patient-specific need that cannot be met by the approved drug product? These are important questions. As Pitts describes it, some in the industry appear to favor opening the door to compounding more widely. At the same time, FDA must balance public health needs and patient access with the safety and efficacy concerns that traditionally fall within the Agency’s purview. Where that line will ultimately be drawn may become clearer once FDA makes a final decision on the peptide issue. Recent court decisions appear to support FDA’s position on the shortage issue, and the recent increase in warning letters to compounders suggests that the Agency may already be taking a more enforcement-oriented approach.
