42 U.S.C. § 263–1 — Education on biological products

(a) Internet website. The Secretary may maintain and run a website with educational materials for health care providers, patients, and caregivers, explaining what the relevant terms mean and how biological products — including biosimilar biological products and interchangeable biosimilar biological products — are reviewed and licensed. That content may include: explanations of key legal and regulatory terms, including "biosimilar" and "interchangeable," and clarification about how interchangeable biosimilars can be used; information about the development programs for these products and relevant clinical considerations for prescribers, which may include information about how comparable a biosimilar is to its reference product; an explanation of how to report adverse events for these products; and an explanation of how biosimilar and interchangeable biosimilar products licensed under section 262(k) relate to their "reference products" (defined in section 262(i)), including how each type of product is reviewed and licensed. These materials may take the form of webinars, continuing-education modules, videos, fact sheets, infographics, toolkits for stakeholders, or other formats the Secretary finds appropriate, and may be tailored to the different needs of providers, patients, caregivers, and other audiences. On top of this, the Secretary must keep publishing, for each biological product licensed under section 262(a) or 262(k), either the product's action package or its summary review. Nothing in this subsection allows the Secretary to disclose trade secrets, confidential commercial or financial information, or other material protected under section 552(b) of title 5. (b) Continuing education. The Secretary must work to advance education and awareness among health care providers about biological products — including biosimilar and interchangeable biosimilar biological products — as appropriate, including by developing or improving continuing-education programs that help providers learn about prescribing these products and the clinical considerations involved.