Sec. 2. Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition
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Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505E the following: The Secretary shall designate a drug as a drug approved for a new indication to prevent, diagnose, or treat a rare disease or condition for purposes of granting the extensions under subsection
(b)if— prior to approval of an application or supplemental application for the new indication, the drug was approved or licensed for marketing under section 505(c) of this Act or section 351(a) of the Public Health Service Act, but was not so approved or licensed for the new indication; the sponsor of the approved or licensed drug files an application or a supplemental application for approval of the new indication for use of the drug to prevent, diagnose, or treat the rare disease or condition; and the Secretary approves the application or supplemental application; and the application or supplemental application for the new indication contains the consent of the applicant to notice being given by the Secretary under paragraph
(4)respecting the designation of the drug. Except as provided in subparagraph (B), a designation under this subsection shall not be revoked for any reason. The Secretary may revoke a designation of a drug under paragraph
(1)if the Secretary finds that the application or supplemental application resulting in such designation contained an untrue statement of material fact. A designation of a drug under paragraph
(1)shall be subject to the condition that the sponsor of the drug will notify the Secretary of any discontinuance of the production of the drug for solely commercial reasons at least one year before such discontinuance. Notice respecting the designation of a drug under paragraph
(1)shall be made available to the public. If the Secretary designates a drug as a drug approved for a new indication for a rare disease or condition, as described in subsection (a)(1)— the 4-, 5-, and 7 ½ -year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year periods described in clauses
(iii)and
(iv)of subsection (c)(3)(E) and clauses
(iii)and
(iv)of subsection (j)(5)(F) of section 505, and the 7-year period described in section 527, as applicable, shall be extended by 6 months; or the 4- and 12-year periods described in subparagraphs
(A)and
(B)of section 351(k)(7) of the Public Health Service Act and the 7-year period described in section 527, as applicable, shall be extended by 6 months; and if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 or a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of 6 months after the date the patent expires (including any patent extensions); or if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of 6 months after the date the patent expires (including any patent extensions). Any extension under subsection
(b)of a period shall be in addition to any extension of the periods under sections 505A and 505E of this Act and section 351(m) of the Public Health Service Act, as applicable, with respect to the drug. The extension described in subsection
(b)shall not apply if the drug designated under subsection (a)(1) has previously received an extension by operation of subsection (b). In this section, the term rare disease or condition has the meaning given to such term in section 526(a)(2). . Section 505F of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only with respect to a drug for which an application or supplemental application described in subsection (a)(1)(B)(i) of such section 505F is first approved under section 505(c) of such Act ( 21 U.S.C. 355(c) ) or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) on or after the date of the enactment of this Act. Section 505A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a ) is amended— in subsection (b), by adding at the end the following: Notwithstanding the references in subsection (b)(1) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in subsection (b)(1) shall be in addition to any extensions under section 505F. ; and in subsection (c), by adding at the end the following: Notwithstanding the references in subsection (c)(1) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in subsection (c)(1) shall be in addition to any extensions under section 505F. . Subsection
(b)of section 505E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355f ) is amended— by amending the subsection heading to read as follows: ; and Relation to pediatric exclusivity and exclusivity for a drug approved for a new indication for a rare disease or condition by striking any extension of the period under section 505A and inserting any extension of the periods under sections 505A and 505F, as applicable, . Section 351(m) of the Public Health Service Act ( 42 U.S.C. 262(m) ) is amended by adding at the end the following: Notwithstanding the references in paragraphs (2)(A), (2)(B), (3)(A), and (3)(B) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in such paragraphs shall be in addition to any extensions under section 505F. .
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Sec. 2
Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition
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