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* Correspondence: Nannan Shi, [email protected]

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Seeking to amend the federal Food, Drug, and Cosmetic Act (FDCA), the bills sponsors frame the proposed legislation as essential to protect patients from untested, unapproved, and potentially dangerous mass compounded drugs. The bill was immediately referred to the House Committee on Energy and Commerce

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Precedent comes from the Cell and Gene Therapy Access Model, which requires participating states to meet coverage and prior authorization standards to get negotiated prices for sickle cell therapies