In a letter issued on August 6, 2025, the FDA moved the deadline for manufacturers of NDT to secure approval from 2029 to August 2026. This abrupt change drastically reduces the time frame for compliance and puts patients at risk of losing access to the only treatment that works for them.
The FDA is attempting to reclassify NDT as a biologic, arguing that because it is derived from porcine thyroid glands and contains thyroglobulin protein, it meets the definition. Critics—including physicians, patient advocates, and most NDT manufacturers—dispute this reasoning, pointing out that biologics are typically injectable medications for autoimmune conditions, not oral thyroid tablets. Preparing a Biologics License Application (BLA) is a lengthy and prohibitively expensive process, and as of August 2025, no manufacturer has publicly filed one. Without approval, patients may be forced to switch to synthetic thyroid hormones such as levothyroxine, which many have already tried without success.
Beyond the looming deadline, the FDA’s reclassification will also ban compounded NDT prescriptions and likely prohibit imports from abroad. If NDT is eventually approved as a biologic, its price is expected to rise significantly—putting it out of reach for uninsured patients and those on Medicare, who are excluded from copay assistance programs.
“Thyroid patients deserve safe, reliable, and affordable access to the treatments that work best for them,” said Leigh Erin Connealy, MD, Medical Director of the Center for New Medicine. “For many, NDT is not just a preference—it is the only option that keeps them healthy and thriving. Cutting off this lifeline would be devastating.”
Patient advocacy groups, including Paloma Health, are mobilizing to resist the reclassification and accelerated timeline. They are encouraging patients and physicians to sign petitions, contact their legislators, and begin discussing contingency plans with their healthcare providers before the August 2026 deadline.
The Center for New Medicine stands with patients and providers in urging the FDA to reconsider this policy shift and allow continued access to NDT.
Sign the petition on Change.org.
About the Center for New Medicine
The Center for New Medicine, located in Irvine, California, is one of the largest integrative medical clinics in North America, specializing in functional medicine, oncology, chronic disease, and thyroid health. Led by Leigh Erin Connealy, MD, the center is committed to patient-centered care that combines the best of advanced technology and evidence-informed natural medicine.
