---
title: Carter, Harshbarger call out FDA on DTE
description: A big APC thanks to Reps. Buddy Carter and Diana Harshbarger for the joint letter they sent to FDA Commissioner Marty Makary about DTE.
---

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# [Carter, Harshbarger call out FDA on DTE](https://a4pc.org/news/carter-harshbarger-call-out-fda-on-dte)

 Written by [Andrew](https://a4pc.org/news/author/andrew) | Oct 23, 2025

A big APC thanks to Reps. Buddy Carter and Diana Harshbarger — we knew we had their support in the fight to get the FDA to reverse its decision on DTE, and now they’ve shown that support directly. [They sent a joint letter](https://a4pc.org/hubfs/PDFs/2025-10-17_Carter-Harshbarger-DTE-Letter-FDA.pdf) to FDA Commissioner Marty Makary not just expressing their concern about the agency’s decision, but clearly explaining why it was wrong both scientifically and in terms of agency precedent: “By FDA’s own long-standing guidance, a drug product that contains a protein only as an inactive ingredient is not considered a ‘biological product’.”

And then they pointed out the practical side — that “This requirement is unworkable and could result in only one manufacturer achieving licensure, creating a monopoly, driving up costs, and jeopardizing supply.”

Combined with [our ongoing, multi-pronged campaign](https://www.compounding.com/thyroid) to reverse the FDA’s decision (you are helping with that, right?) we’ve got a good feeling that the pressure will build and Makary and the agency will realize their mistake and reverse their decision … sooner rather than later.

[View full post](https://a4pc.org/news/carter-harshbarger-call-out-fda-on-dte)

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