September 20, 2024

Settlement reached in Evexias suit against FDA

A settlement has been reached in a lawsuit brought by Evexias et al against FDA over the agency’s 2023 addition of a number of substances to Category 2 of the 503A bulks list.

Almost a year ago, the FDA announced that it had updated the list of bulk drug substances nominated for use under section 503A. Notably, several peptides were added to Category 2 “because FDA has identified significant safety risks with [those] substances,” the agency said.

That raised alarms from some prescribers and pharmacy compounders, who were concerned that patient access to what they say are legitimate therapies that are clinically effective was taken away and that FDA did not substantiate the “safety risks” it says it identified related to those substances.

APC agreed that in not showing its work on the evidence of safety risk, FDA once again failed to document its action. “Trust us” is not a sufficient explanation for agency actions. APC wrote a letter last year to Gail Bormel, director of FDA’s Office of Compounding Quality and Compliance, calling for transparency regarding the addition of substances to category 2.

Evexias Medical Group and Farmakeio Outsourcing sued FDA for that lack of transparency in placing more than a dozen peptides in category 2 of the 503A interim bulks list. 

One result of this week’s settlement is the publishing of a Federal Register notice for two upcoming meetings of the Pharmacy Compounding Advisory Committee, in which it will review four of those peptides and their nomination for inclusion on the FDA Bulks list. The two PCAC meetings are scheduled for October 29 and December 4. 

This settlement is a win in that it reiterates that FDA must go through proper notice and rulemaking process — including PCAC review — before taking action to categorize any API. It also gives stakeholders the chance to present evidence surrounding the patient use and benefits of the peptides in question. 

“The best way to have the Pharmacy Compounding Advisory Committee consider and recommend substances for inclusion in category 1 of the bulks list — which means they can be compounded — is to make a compelling case for clinical efficacy and submit it to FDA,” said APC’s Chief Advocacy Officer Tenille Davis, PharmD. “Such a case would need to rely on rigorous science, credible research, and potent patient outcome data. If you have that evidence, this is your chance to offer it.” 

Evexias’ lawyers are also looking for data on the number of prescriptions dispensed for compounded peptides (the information submitted will not be shared). Pharmacies who want to support Evexias’ legal efforts can do that at peptidelegalfund.com.