Sec. 391. Protecting access to biological products
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Section 351(k)(7) of the Public Health Service Act ( 42 U.S.C. 262(k)(7) ) is amended by adding at the end the following: An approved application that is deemed to be a license for a biological product under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection
(a)for purposes of subparagraphs
(A)and (B). Subparagraph
(C)shall apply with respect to a reference product referred to in such subparagraph that was the subject of an approved application that was deemed to be a license pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009. The exclusivity periods described in section 527, section 505A(b)(1)(A)(ii), and section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act shall continue to apply to a biological product after an approved application for the biological product is deemed to be a license for the biological product under subsection
(a)pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009. .
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Sec. 391
Protecting access to biological products
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