Sec. 103. Promoting the development of innovative diagnostics
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The manufacturer or sponsor of a medicine may request the Secretary to determine that— a diagnostic test has been developed by, or with the participation of, the manufacturer or sponsor of the medicine; and use of the diagnostic test, as demonstrated through valid scientific information such as peer-reviewed literature— provides for or improves the identification of a patient population for which the medicine will or will not be used in accordance with its approved indications; provides for or improves the determination of the most appropriate treatment option for a patient population with the medicine in accordance with its approved indications; or provides for the detection of a qualifying pathogen (as defined in section 505E(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(f) ).
Not later than 30 days after the submission of a request under paragraph (1), the Secretary, shall— make the requested determination and publish a notice of such determination and any extension under this section resulting from such determination; or provide an explanation to the manufacturer or sponsor submitting the request of why the determination is not warranted. For purposes of subsections
(c)and (d), the applicable extension period is— with respect to a diagnostic test developed (as described in subsection (a)(1)(A)) contemporaneously with the development of the medicine involved, 12 months; and with respect to a diagnostic test developed otherwise, 6 months. If, at the request of the manufacturer or sponsor of a drug, the Secretary makes the determination described in subsection (a)(1) with respect to such drug and a diagnostic test, then— the four- and five-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), the three-year periods described in clauses
(iii)and
(iv)of subsection (c)(3)(E) and clauses
(iii)and
(iv)of subsection (j)(5)(F) of such section 505, or the seven-year period described in section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ), as applicable, shall be extended by the applicable extension period; 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 such section 505; or a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of such section 505, then the period during which an application may not be approved under subsection (c)(3) or (j)(5)(B) of such section 505 shall be extended by the applicable extension period after the date the patent expires (including any patent extensions); and 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 such 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 subsection (c)(3) or (j)(5)(B) of such section 505 shall be extended by the applicable extension period after the date the patent expires (including any patent extension). If, at the request of the manufacturer or sponsor of a biological product, the Secretary makes the determination described in subsection (a)(1) with respect to such biological product and a diagnostic test, then the 12-year period described in subsection (k)(7)(A) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), the 4-year period described in subsection (k)(7)(B) of such section 351, and the 7-year period described in section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ), as applicable, shall be extended by the applicable extension period. Any extension under subsection
(c)or
(d)of a period shall be in addition to any extension of the period under section 505A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a ) with respect to the medicine. Extensions under this section may apply— not more than twice with respect to the same medicine; and not more than once with respect to the same indication to be treated by the same medicine.
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Sec. 103
Promoting the development of innovative diagnostics
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