Sec. 303. Rewarding innovative drug development
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Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5) ) is amended— in subparagraph (B)— in clause (i), by inserting except that such approval may not be made effective before the date that is 5 years after the date on which the drug to which the application refers was approved under subsection
(c)before the period; and in clause (ii), by inserting except that such approval may not be made effective before the date that is 5 years after the date on which the drug to which the application refers was approved under subsection
(c)before the period; and in subparagraph (F)(ii)— by striking expiration of five years and inserting expiration of 3 years ; by striking , except that such an application may be submitted under this subsection after the expiration of four years from the date of the approval of the subsection
(b)application if it contains a certification of patent invalidity or noninfringement described in subclause
(IV)of paragraph (2)(A)(vii) ; and by striking seven and one-half years and inserting 6 and one-half years . Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended— in subsection (v)(2)(A)(i)(II) of section 505, by inserting the 3-year exclusivity period referred to before under clause
(ii)of subsection (j)(5)(F) ; in subsections (b)(1)(A)(i)(I) and (c)(1)(A)(i)(I) of section 505A— by striking five years each place such term appears and inserting 3 years ; by striking seven and one-half years each place such term appears and inserting 6 and one-half years ; and by striking eight years each place such term appears and inserting 7 years ; and in section 505E, by striking the 4- and 5-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) and inserting the 4- and 5-year periods described in subsection (c)(3)(E)(ii) of section 505, the 3-year periods described in clauses
(iii)and
(iv)of subsection (c)(3)(E) and clauses (ii), (iii), and
(iv)of subsection (j)(5)(F) . Section 505(c)(3)(E)(iv) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E)(iv) ) is amended by inserting , and the supplement shows a significant clinical benefit over existing therapies manufactured by the applicant in the 5-year period preceding the submission of the application, before the Secretary . Section 351(k)(7)(A) of the Public Health Service Act ( 42 U.S.C. 262(k)(7)(A) ) is amended by striking 12 years and inserting 7 years . Paragraphs (2)(A) and (3)(A) of section 351(m) of the Public Health Service Act ( 42 U.S.C. 262(m) ) is amended by striking 12 years each place it appears and inserting 7 years . The amendments made by subsection
(a)apply only with respect to a drug or biological product for which the listed drug (as described in section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7) )) or reference product (as such term is used in section 351 of the Public Health Service Act ( 42 U.S.C. 262 )) is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or licensed under section 351(a) of the Public Health Service Act, as applicable, on or after the date of enactment of this Act. Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study and submit to Congress a report that includes— the number of requests for designation as a drug for a rare disease or condition under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb ) the Food and Drug Administration receives each year in the previous 10-year period; the number of such requests granted, denied, and pending; the names of all drugs receiving such designation during such period, including the date of approval and indication for which market exclusivity was granted; and any drugs for which such designation has been revoked or amended during such period; for each drug so designated as a drug for a rare disease or condition in the previous 10-year period, the total annual expenditures for such drugs under the Medicare program under title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq.) and the Medicaid program under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.), the number of Medicare and Medicaid beneficiaries who used each such drug each year during such time period, and any changes in price per unit during such time period; and for a sample of drugs (selected by the Comptroller General) so designated in the previous 10-year period, to the extent feasible— gross revenues of the manufacturers with respect to each such drug, and manufacturer spending for marketing and patient assistance programs; the average price per drug and how those prices changed over time for the selected drugs based on industry drug pricing benchmarks; and the indications that were the basis of such designation and other approved indications for the drugs, and the indications for which each drug has most commonly been used, including non-approved indications for which the drug may be recommended by external organizations such as physician or patient organizations.
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Sec. 303
Rewarding innovative drug development
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