117 STAT. 1938
PUBLIC LAW 108–155—DEC. 3, 2003 age group if the applicant certifies and the Secretary finds that— ‘‘(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) the drug or biological product— ‘‘(I) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in that age group; and ‘‘(II) is not likely to be used by a substantial number of pediatric patients in that age group; 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. ‘‘(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. ‘‘(b) MARKETED DRUGS AND BIOLOGICAL PRODUCTS.— ‘‘(1) IN GENERAL.—After providing notice in the form of a letter and an opportunity for written response and a meeting, which may include an advisory committee meeting, the Secretary may (by order in the form of a letter) require the holder of an approved application for a drug under section 505 or the holder of a license for a biological product under section 351 of the Public Health Service Act (42 U.S.C. 262) to submit by a specified date the assessments described in subsection (a)(2) if the Secretary finds that— ‘‘(A)(i) the drug or biological product is used for a substantial number of pediatric patients for the labeled indications; and ‘‘(ii) the absence of adequate labeling could pose significant risks to pediatric patients; or ‘‘(B)(i) there is reason to believe that the drug or biological product would represent a meaningful therapeutic benefit over existing therapies for pediatric patients for one or more of the claimed indications; and ‘‘(ii) the absence of adequate labeling could pose significant risks to pediatric patients. ‘‘(2) WAIVERS.— ‘‘(A) FULL WAIVER.—At the request of an applicant, the Secretary shall grant a full waiver, as appropriate, of the requirement to submit assessments under this subsection if the applicant certifies and the Secretary finds that— ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of
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