The "Deemed To Be a License" Provision of the BPCI Act; Questions and Answers; Guidance for Industry

A patient who relies on desiccated thyroid extract (DTE) for their health opposes the FDA's reclassification of DTE as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options from compounding pharmacies, potentially harming patients who do not respond well to synthetic medicines.

A patient who relies on desiccated thyroid extract (DTE) for their health opposes the FDA's reclassification of DTE as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options from compounding pharmacies, potentially harming patients who do not respond well to synthetic medicines.

A patient who relies on desiccated thyroid extract (DTE) for their health opposes the FDA's reclassification of DTE as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options from compounding pharmacies, potentially harming patients who do not respond well to synthetic medicines.

A patient who relies on desiccated thyroid extract (DTE) for their health opposes the FDA's reclassification of DTE as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options from compounding pharmacies, potentially harming patients who do not respond well to synthetic medicines.

A patient who relies on desiccated thyroid extract (DTE) for their health opposes the FDA's reclassification of DTE as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options from compounding pharmacies, potentially harming patients who do not respond well to synthetic medicines.

A patient who relies on desiccated thyroid extract (DTE) for their health opposes the FDA's reclassification of DTE as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options from compounding pharmacies, potentially harming patients who do not respond well to synthetic medicines.

A patient who relies on desiccated thyroid extract (DTE) for their health opposes the FDA's reclassification of DTE as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options from compounding pharmacies, potentially harming patients who do not respond well to synthetic medicines.

Tanya Galbavy Stern, a patient, opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. She argues that this change creates unnecessary barriers to access, threatens the role of compounding pharmacies, and prioritizes corporate profits over patient needs.

A patient who relies on desiccated thyroid extract (DTE) for their health opposes the FDA's reclassification of DTE as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options from compounding pharmacies, potentially harming patients who do not respond well to synthetic medicines.

A patient who relies on desiccated thyroid extract (DTE) for their health opposes the FDA's reclassification of DTE as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options from compounding pharmacies, potentially harming patients who do not respond well to synthetic medicines.