121 STAT. 870
dkrause on GSDDPC44 with PUBLAW
Public information. Web site.
VerDate Aug 31 2005
08:41 Jul 13, 2009
PUBLIC LAW 110–85—SEPT. 27, 2007
‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of patients in that age group is so small or patients in that age group are geographically dispersed); ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in that age group; ‘‘(iii)(I) the drug or biological product— ‘‘(aa) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in that age group; and ‘‘(bb) is not likely to be used in a substantial number of pediatric patients in that age group; and ‘‘(II) the absence of adequate labeling could not pose significant risks to pediatric patients; or ‘‘(iv) the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age group have failed. ‘‘(C) PEDIATRIC FORMULATION NOT POSSIBLE.—If a waiver is granted on the ground that it is not possible to develop a pediatric formulation, the waiver shall cover only the pediatric groups requiring that formulation. An applicant seeking either a full or partial waiver shall submit to the Secretary documentation detailing why a pediatric formulation cannot be developed and, if the waiver is granted, the applicant’s submission shall promptly be made available to the public in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration. ‘‘(D) LABELING REQUIREMENT.—If the Secretary grants a full or partial waiver because there is evidence that a drug or biological product would be ineffective or unsafe in pediatric populations, the information shall be included in the labeling for the drug or biological product. ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code. ‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and paragraphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or biological product shall be considered to represent a meaningful therapeutic benefit over existing therapies if the Secretary determines that— ‘‘(1) if approved, the drug or biological product could represent an improvement in the treatment, diagnosis, or prevention of a disease, compared with marketed products adequately labeled for that use in the relevant pediatric population; or ‘‘(2) the drug or biological product is in a class of products or for an indication for which there is a need for additional options. ‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person fails to submit an assessment described in subsection (a)(2), or a request for approval of a pediatric formulation described in subsection (a) or (b), in accordance with applicable provisions of subsections (a) and (b)—
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