APC to Makary: Reverse that DTE ban

This week, APC sent an unambiguous letter to FDA Commissioner Marty Makary — one demanding that the agency rescind its reclassification of desiccated thyroid extract (DTE) and similar products as “biological.”

In case you missed it, it recently came to light that among other decisions, the agency’s planned DTE ban was allegedly part of a personal vendetta on the part of George Tidmarsh, the former head of the agency’s drug division. (Former, as he resigned from the agency on Nov. 2 after the news broke.)

So, as we put it bluntly in the letter, “[T]he timing and context of the FDA’s biologic reclassification of animal-derived thyroid products [...] heighten concern that such alleged conduct by Dr. Tidmarsh may have influenced policy in a manner inconsistent with FDA’s own guidance and statutory framework.”

Pointing out — again! — the various policy and scientific issues with the decision, we asked that FDA reverse its position that DTE products are biologicals, and stop any enforcement actions while it irons out the contradictions in its policies.

These accusations against Tidmarsh appear to be credible. If true — it goes a long way to explaining that illogical, out-of-nowhere FDA ban on DTE.