Congressman Michael Rulli (R-OH) has introduced the Protecting Equal Access to Thyroid (PEAT) Act of 2026 – a bill that would directly address the FDA’s controversial reclassification of desiccated thyroid extract as a biologic. The legislation would amend the Public Health Service Act to prohibit treating a product as a biological product based solely on the presence of a protein that is a clinically inactive component – which is precisely the argument against the FDA's DTE classification. As we've covered extensively, that reclassification would effectively ban compounding of DTE, cutting off access for potentially millions of patients who rely on it when synthetic alternatives haven't worked for them.
The bill builds on a letter Congresswoman Diana Harshbarger and Congressman Earl "Buddy" Carter sent to FDA Commissioner Makary last October, making the same core argument: thyroglobulin, the protein FDA is using to justify the biologic classification, is an inactive ingredient in DTE – not its active component. The clinical benefit comes from two well-understood small molecule hormones, levothyroxine and liothyronine. FDA's own long-standing guidance supports that distinction.
For the millions of patients whose access to compounded DTE hangs on how this classification question is resolved, the PEAT Act is a meaningful step in the right direction. It's also one of the primary talking points at PCCA's upcoming ACT Legislative Conference in Washington, D.C. – a great opportunity for compounders to take this message directly to lawmakers. Worth checking out if you're looking for a way to put your voice to work on this issue.