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Full Text of this Amendment
At the end of section 505 of the Federal Food, Drug, and Cosmetic Act, as amended by section 251 of the bill, add the following:
``(r) Certification of Information.--
``(A) REQUIREMENT.--When submitting information in support of a new drug application or a supplemental new drug application, the sponsor shall certify, in writing, that the information submitted to the Food and Drug Administration complies with the requirements of this Act and that such information is not false or misleading.
``(B) FAILURE TO SUBMIT.--If the sponsor fails to provide a certification as required under subparagraph (A), the Secretary shall transmit to such sponsor a notice stating that such sponsor shall submit the certification by a date determined by the Secretary. If, by the date specified by the Secretary in the notice under this subparagraph, the Secretary has not received the certification, the Secretary, after providing the opportunity for a hearing, shall order such sponsor to pay a civil
monetary penalty of $10,000 for each day after such date that such certification is not submitted.
``(C) ADDITIONAL CIVIL MONETARY PENALTY.--If the Secretary determines, after notice and opportunity for a hearing, that a sponsor knew or should have known that the information submitted in support of a new drug application or a supplemental new drug application was false or inaccurate, the Secretary shall order such sponsor to pay a civil monetary penalty of not less than $100,000, but not to exceed $2,000,000.
``(2) REQUIRED STATEMENT.--The certification under paragraph (1) shall include a statement that all clinical trials, federally or privately funded, whether conducted within or outside the United States, related to the safety or efficacy of the drug under review, have been submitted to the Food and Drug Administration.
``(3) CLINICAL COMPARISON STUDIES.--
``(A) IN GENERAL.--The Secretary shall deposit funds collected under paragraph (1) into an account and use such funds shall be used, after consultation with the Director of the Agency for Healthcare Research and Quality, to fund studies that compare the clinical effectiveness of 2 or more treatments for similar diseases or conditions.
``(B) PRIORITY LIST.--The Secretary shall award funding under subparagraph (A) based on a priority list established, not later than 6 months after the date of enactment of this Act, by the Director of the Agency for Healthcare Research and Quality and periodically updated as determined appropriate by the Director.
``(4) DRUG CONSULTATIONS.--Not later than 90 days after the date of the completion of a written consultation on a drug concerning the drug's safety, as conducted by the Office of Surveillance and Epidemiology, regardless of whether such consultation was initiated by such Office or by an entity outside of the Office, the Commissioner of Food and Drugs shall make available to the public a full copy of such consultation.
``(5) RULE OF CONSTRUCTION.--Nothing in this subsection shall be construed to alter or amend section 301(j) of this Act or section 1905 of title 18, United States Code.''.
(As printed in the Congressional Record for the Senate on May 1, 2007.)