Sec. 321. Limiting exclusivity periods for drugs treating rare diseases and conditions
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Subsection
(a)of section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ) is amended to read as follows: Except as provided in subsection (b), if the Secretary approves an application filed pursuant to section 505, or issues a license under section 351 of the Public Health Service Act, for a drug designated under section 526 for a rare disease or condition, the Secretary may not approve an application filed pursuant to section 505, or issue a license under section 351 of the Public Health Service Act, for the same drug for the same disease or condition for a person who is not the holder of such approved application or of such license until the expiration of the exclusivity period described in paragraph (2). The exclusivity period described in this paragraph, with respect to a drug designated under section 526 for a rare disease or condition, is— a single 7-year period of exclusivity with respect to the first designation of such drug under such section for that rare disease or condition; or in the case of a drug that has previously received a period of exclusivity under paragraph (1), a single 3-year period of exclusivity with respect to any subsequent designation of such drug under such section for any other rare disease or condition. In the case of a drug that has received two periods of exclusivity pursuant to paragraph (1), no additional exclusivity period under this section is available with respect to such drug, regardless of whether such drug has been designated under section 526 for a rare disease or condition that is distinct from the rare disease or condition for which such exclusivity periods were granted. . Section 505(j)(5)(B)(iv)(II)(dd)(AA) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ) is amended by striking 7-year period and inserting exclusivity period . Section 505A(b)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ) is amended by striking rather than seven years; and inserting , or three years and six months, rather than seven years or three years, respectively; . Section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ) is amended by striking rather than seven years; and inserting , or three years and six months, rather than seven years or three years, respectively; . Section 505E(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ) is amended by striking 7-year period and inserting exclusivity periods . Section 527(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ) is amended by striking the 7-year period and inserting any exclusivity period . Section 351(m)(2)(B) of the Public Health Service Act ( 42 U.S.C. 262 ) is amended by striking rather than 7 years and inserting or 3 years and 6 months, rather than 7 years or 3 years, respectively . Section 351(m)(3)(B) of the Public Health Service Act ( 42 U.S.C. 262 ) is amended by striking rather than 7 years and inserting or 3 years and 6 months, rather than 7 years or 3 years, respectively .
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Sec. 321
Limiting exclusivity periods for drugs treating rare diseases and conditions
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