A regulatory roundup published by RAPS reports that a drug safety group has filed a citizen petition asking FDA to stop the compounding of certain peptides, days after the HHS secretary said the administration wants to open a state-regulated marketplace for them.

Compounding is the practice of a pharmacy making a drug to order rather than buying it finished from a manufacturer. The peptides in question are not FDA-approved products, and the fight is over whether 503A compounding pharmacies, the small-scale patient-specific kind, should be allowed to make them at all.

The six on the list

Over the summer an FDA advisory committee recommended adding six peptides to the 503A compounding list: BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. That is a notable set of names, because most of them have spent the last several years circulating entirely outside any regulated channel.

HHS and FDA have submitted an interim access policy to the Office of Management and Budget that would temporarily let specialized compounding pharmacies produce these peptides while permanent rules are written.

Two arguments, same safety word

HHS Secretary Robert F. Kennedy Jr. said Tuesday that routing access through 503A compounders would offer additional safety protections for consumers who might otherwise buy from unregulated gray- or black-market sellers, according to Inside Health Policy as cited in the roundup. The Partnership for Safe Medicines, which filed the citizen petition, argues the opposite: that compounding these peptides is illegal and poses safety risks.

Both sides are claiming the safety ground, which is usually the sign of a question that is really about jurisdiction. Nobody in this dispute is arguing about efficacy data, and that absence is worth noticing.

Elsewhere at the agency

The same week brought the Faster Clinical Trials Act, introduced by Reps. Jake Auchincloss and Morgan Griffith, which would simplify trial participation, shorten startup times and advance human-based models and artificial intelligence as alternatives to animal testing. It would also create a Center for Clinical Trial Innovation inside CDER, tasked with standing up at least three trial networks in its first year.

Bottom line

The interim policy is at OMB and the petition is filed, so FDA now has to answer both. Until it does, the six peptides sit in the same unregulated place they already occupied.