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

(a)

Internet website

(1)

In general

The Secretary may maintain and operate an internet website to provide educational materials for health care providers, patients, and caregivers, regarding the meaning of the terms, and the standards for review and licensing of, biological products, including biosimilar biological products and interchangeable biosimilar biological products.

(2)

Content

Educational materials provided under paragraph (1) may include—

(A)

explanations of key statutory and regulatory terms, including “biosimilar” and “interchangeable”, and clarification regarding the use of interchangeable biosimilar biological products;

(B)

information related to development programs for biological products, including biosimilar biological products and interchangeable biosimilar biological products and relevant clinical considerations for prescribers, which may include, as appropriate and applicable, information related to the comparability of such biological products;

(C)

an explanation of the process for reporting adverse events for biological products, including biosimilar biological products and interchangeable biosimilar biological products; and

(D)

section 262(k) of this title section 262(i) of this title an explanation of the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under and reference products (as defined in ), including the standards for review and licensing of each such type of biological product.

(3)

Format

The educational materials provided under paragraph (1) may be—

(A)

in formats such as webinars, continuing education modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats as appropriate and applicable; and

(B)

tailored for the unique needs of health care providers, patients, caregivers, and other audiences, as the Secretary determines appropriate.

(4)

Other information

In addition to the information described in paragraph (2), the Secretary shall continue to publish—

(A)

section 262 of this title the action package of each biological product licensed under subsection (a) or (k) of ; or

(B)

section 262 of this title the summary review of each biological product licensed under subsection (a) or (k) of .

(5)

Confidential and trade secret information

section 552(b) of title 5This subsection does not authorize the disclosure of any trade secret, confidential commercial or financial information, or other matter described in .

(b)

Continuing education

The Secretary shall advance education and awareness among health care providers regarding biological products, including biosimilar biological products and interchangeable biosimilar biological products, as appropriate, including by developing or improving continuing education programs that advance the education of such providers on the prescribing of, and relevant clinical considerations with respect to, biological products, including biosimilar biological products and interchangeable biosimilar biological products.

July 1, 1944, ch. 373 Pub. L. 117–8, § 2Apr. 23, 2021135 Stat. 254(, title III, § 352A, as added , , .)