November 11, 2022

Bormel says “DTE remains available.” But how?

One takeaway from compounding industry leaders’ meeting this past Wednesday with FDA officials about the reclassification of desiccated thyroid extract as a biologic: The agency is inconsistent about which substances it has reclassified and which products the reclassification affects.

“DTE remains available,” FDA OCQC Director Gail Bormel said in the meeting, noting that commercially available Thyroid USP remains on the market. APC leaders pointed out that while the manufactured DTE products continue to be available, the letter sent to NABP and ultimately to boards of pharmacy had caused some suppliers of DTE to stop selling the API to pharmacies, and some pharmacies are being told by their board inspectors that they can no longer compound DTE to meet the needs of their patients.

When asked what policy goal the agency was trying to address in reclassifying DTE as a biologic, Bormel indicated that the reclassification was always going to happen because of the BCPI Act (passed by Congress in 2010, with enforcement that began March 2020). APC leaders replied that Thyroid USP was never listed in any official notices regarding BCPI reclassification—unlike other substances like HCG—and also that thyroglobulin is not an active ingredient in Thyroid USP, and is not listed in its monograph, package insert or labeling.

“The agency seems to be focused on thyroglobulin based on research related to some old products that had listed it as an active ingredient, but which were taken off the market years ago,” said APC President Dave Miller after the meeting. “So they’re jumping to DTE, which contains thyroglobulin as a by-product, and they’re making no distinction that it’s not the active ingredient.”

The agency seemed quite interested in rough data APC provided citing at least 60,000 patients who are affected by the agency action restricting compounded DTE, and asked APC to submit those numbers – and its other arguments as well—via the docket the agency has established on this issue.

“We have heard a lot on this issue,” said Bormel. “The concerns are definitely on our radar.”

The virtual meeting had been requested by APC and was also attended by more than 30 representatives of FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, as well as APC-invited representatives from the National Association of Board of Pharmacy, American Pharmacists Association, National Community Pharmacists Association, and the Outsourcing Facilities Association. APC President Dave Miller, Board member Michelle Moser, member Matt Martin of PCCA, and CEO Scott Brunner enunciated APC’s concerns.

What can you do?

Submit written comments to the FDA docket and focus those comments in particular on the patient impacts of the reclass – including why compounded DTE is the best alternative for many patients. Your comments should be well reasoned and science-based, documented to the extent possible with citations supporting the research to which you may refer.

APC is considering issuing a call-to-action to DTE patients, and we’ll likely have more to share about that soon.