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

A patient who has used desiccated thyroid extract (DTE) since the 1970s 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 the ability of compounding pharmacies to provide the treatment.

Jennifer Beeman, a patient, opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. She argues that this change will create barriers to access, increase costs, and eliminate the ability of compounding pharmacies to provide a vital treatment for patients who do not respond well to synthetic medicines.

A functional medicine practitioner opposes the reclassification of Desiccated Thyroid Extract (DTE) as a biologic. They argue that this change will restrict patient access to tailored, compounded thyroid medications that are essential for managing specific health conditions.

A patient who suffers from severe allergies to synthetic pharmaceuticals opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate the ability of compounding pharmacies to provide a vital treatment option.

The commenter, who is a patient and an office manager for a medical practitioner, opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They argue that this change will restrict patient access to an effective treatment, increase costs, and undermine clinical judgment by removing DTE from the compounding pharmacy supply chain.

J. Michael McClendon, a private individual and patient, opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. He argues that this change will create barriers to access, increase costs, and eliminate the ability of compounding pharmacies to provide a treatment that has been effective for him and his family for years.

A physician who has treated thyroid disease patients for over 10 years opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. The commenter argues that this change will restrict patient access to an essential therapy, increase costs, and undermine clinical judgment by removing DTE from the compounding pharmacy supply chain.

Diane Murphy, a patient with a thyroid condition, 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 will lead to higher costs and fewer treatment options for patients who rely on DTE.

Michael Freund, a patient, opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. He argues that this change will create barriers to access, increase costs, and eliminate the ability of compounding pharmacies to provide this essential treatment to patients who do not respond well to synthetic medicines.

Tonia Biggs, a patient who relies on desiccated thyroid extract (DTE), opposes the FDA's reclassification of DTE as a biologic. She argues that this change will create barriers to access, increase costs, and eliminate the ability of compounding pharmacies to provide the treatment.