Help us do something about it.
FDA’s reclassification of Dessicated Thyroid Extract (DTE) as a biologic is unnecessary, scientifically
flawed, and demonstrably harmful to patients. It strips away choice, likely increases prices, and hands control of a
critical therapy to a single drugmaker.
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DTE has been prescribed and used safely for more than a hundred years to treat millions of Americans with hypothyroidism. Patients depend on it when synthetic options don’t work for them.
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Now, those patients will be left without a vital therapy.
We must push back against this unnecessary overreach by FDA so that patients are not collateral damage in a policy
change that in effect clears the field to create a monopoly for one drugmaker.
Tell FDA to:
- Keep DTE regulated as a small-molecule drug, consistent with science and decades of precedent.
- Reject a monopoly-driven reclassification that limits treatment options and drives up prices for patients.
- Protect patient/provider decision-making by preserving access to DTE alongside synthetic alternatives.
The implications are serious for patients who rely on this therapy.
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