Irvine, CA – The Cancer Center for Healing is sounding the alarm over the Food and Drug Administration’s (FDA) recent decision to shorten the approval timeline for Natural Desiccated Thyroid (NDT) medications—a move that could leave countless thyroid patients without access to the therapy they depend on.
On August 6, 2025, the FDA announced that manufacturers must now secure approval for NDT by August 2026 rather than the previously established 2029 deadline. This sudden three-year cutback has created widespread concern, as no manufacturer has yet filed the required Biologics License Application (BLA). Without approved products on the market, patients may be forced onto alternatives like levothyroxine, which many have already tried unsuccessfully.
The FDA’s justification centers on classifying NDT as a “biologic” because it comes from porcine thyroid glands and contains thyroglobulin protein. However, experts point out that biologics are traditionally injectable treatments for conditions such as autoimmune disorders—not oral thyroid tablets. Preparing a BLA is not only technically complex but also extremely expensive, and the accelerated deadline leaves little realistic opportunity for manufacturers to comply.
This decision also carries additional consequences. If NDT is treated as a biologic, compounded versions will be prohibited, importation from other countries will likely cease, and pricing could rise to levels that place the medication out of reach—especially for uninsured patients and seniors on Medicare, who are barred from using copay assistance programs.
“Patients with thyroid disease often spend years searching for the right treatment, and for many, NDT is the only therapy that restores their quality of life,” said Leigh Erin Connealy, MD, founder of the Cancer Center for Healing. “This regulatory shift could take away their most effective option, leaving them vulnerable to worsening health and unnecessary suffering.”
Patient advocates, including organizations such as Paloma Health, are urging individuals to act now by contacting legislators, signing petitions, and working closely with their doctors to prepare for possible shortages. The Cancer Center for Healing joins these efforts, calling for the FDA to reconsider its decision and to prioritize patient access and safety over regulatory reclassification.
Sign the petition on Change.org.
About the Cancer Center for Healing
The Cancer Center for Healing in Irvine, California, is the largest integrative oncology clinic in North America. Under the leadership of Leigh Erin Connealy, MD, the center offers comprehensive, whole-person cancer care and advanced therapies for chronic conditions, including thyroid disorders. Its mission is to provide patients with access to the safest and most effective treatments available—conventional and natural alike.
