PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 943
construed as affecting the authority of the Secretary of Health and Human Services to request pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act or to require such studies under section 505B of such Act. SEC. 902. ENFORCEMENT.
(a) MISBRANDING.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following: ‘‘(y) If it is a drug subject to an approved risk evaluation and mitigation strategy pursuant to section 505(p) and the responsible person (as such term is used in section 505–1) fails to comply with a requirement of such strategy provided for under subsection (d), (e), or (f) of section 505–1. ‘‘(z) If it is a drug, and the responsible person (as such term is used in section 505(o)) is in violation of a requirement established under paragraph (3) (relating to postmarket studies and clinical trials) or paragraph (4) (relating to labeling) of section 505(o) with respect to such drug.’’. (b) CIVIL PENALTIES.—Section 303(f) of the Federal Food, Drug, and Cosmetic Act, as amended by section 801(b), is amended— (1) by inserting after paragraph (3), as added by section 801(b)(2), the following: ‘‘(4)(A) Any responsible person (as such term is used in section 505–1) that violates a requirement of section 505(o), 505(p), or 505–1 shall be subject to a civil monetary penalty of— ‘‘(i) not more than $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or ‘‘(ii) in the case of a violation that continues after the Secretary provides written notice to the responsible person, the responsible person shall be subject to a civil monetary penalty of $250,000 for the first 30-day period (or any portion thereof) that the responsible person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. ‘‘(B) In determining the amount of a civil penalty under subparagraph (A)(ii), the Secretary shall take into consideration whether the responsible person is making efforts toward correcting the violation of the requirement of section 505(o), 505(p), or 505– 1 for which the responsible person is subject to such civil penalty.’’; and (2) in paragraph (5), as redesignated by section 801(b)(2)(A), by striking ‘‘paragraph (1), (2), or (3)’’ each place it appears and inserting ‘‘paragraph (1), (2), (3), or (4)’’. SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.
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Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended by adding at the end the following: ‘‘The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under section 505– 1(g)(2)(D).’’.
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