Page:United States Statutes at Large Volume 111 Part 3.djvu/221

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2309 "(k) REPORT.—The Secretary shall conduct a study and report to Congress not later than January 1, 2001, based on the experience under the program established under this section. The study and report shall examine all relevant issues, including— "(1) the effectiveness of the program in improving information about important pediatric uses for approved drugs; "(2) the adequacy of the incentive provided under this section; "(3) the economic impact of the program on taxpayers and consumers, including the impact of the lack of lower cost generic drugs on patients, including on lower income patients; and "(4) any suggestions for modification that the Secretary determines to be appropriate.". SEC. 112. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS. (a) IN GENERAL. —Chapter V (21 U.S.C. 351 et seq.), as amended by section 125, is amended by inserting before section 508 the following: "SEC. 506. FAST TRACK PRODUCTS. 21 USC 356. "(a) DESIGNATION OF DRUG AS A FAST TRACK PRODUCT. — "(1) IN GENERAL.—The Secretary shall, at the request of the sponsor of a new drug, facilitate the development and expedite the review of such drug if it is intended for the treatment of a serious or life-threatening condition and it demonstrates the potential to address unmet medical needs for such a condition. (In this section, such a drug is referred to as a 'fast track product'.) "(2) REQUEST FOR DESIGNATION.—The sponsor of a new drug may request the Secretary to designate the drug as a fast track product. A request for the designation may be made concurrently with, or at any time after, submission of an application for the investigation of the drug under section 505(i) or section 351(a)(3) of the Public Health Service Act. " (3) DESIGNATION.— Within 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a fast track product and shall take such actions as are appropriate to expedite the development and review of the application for approval of such product. "(b) APPROVAL OF APPLICATION FOR A FAST TRACK PRODUCT. — "(1) IN GENERAL.—The Secretary may approve an application for approval of a fast track product under section 505(c) or section 351 of the Public Health Service Act upon a determination that the product has an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict clinical benefit. "(2) LIMITATION.— Approval of a fast track product under this subsection may be subject to the requirements— "(A) that the sponsor conduct appropriate post-approval studies to validate the surrogate endpoint or otherwise confirm the effect on the clinical endpoint; and "(B) that the sponsor submit copies of all promotional materials related to the fast track product during the preapproval review period and, following approval and for such period thereafter as the Secretary determines to be

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