Sec. 809. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF GENERIC MEDICINES
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## SEC. 809 GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF GENERIC MEDICINES ###
(a)Study by GAO The Comptroller General of the United States shall conduct a study to determine the following: ####
(1)The rate of first cycle approvals and tentative approvals for applications submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) during the period beginning on October 1, 2012, and ending on September 30, 2017. The rate of first cycle approvals and tentative approvals shall be determined and reported per each GDUFA cohort year during this period. ####
(2)If the rate determined pursuant to paragraph
(1)for any GDUFA cohort year is lower than 20 percent, the reasons contributing to the relatively low rate of first cycle approvals and tentative approvals for generic drug applications shall be itemized, assessed, and reported. In making the assessment required by this paragraph, the Comptroller General shall consider, among other things, the role played by— #####
(A)the Food and Drug Administration’s implementation of approval standards for generic drug applications; #####
(B)the extent to which those approval standards are communicated clearly to industry and applied consistently during the review process; #####
(C)the procedures for reviewing generic drug applications, including timelines for review activities by the Food and Drug Administration; #####
(D)the extent to which those procedures are followed consistently (and those timelines are met) by the Food and Drug Administration; #####
(E)the processes and practices for communication between the Food and Drug Administration and sponsors of generic drug applications; and #####
(F)the completeness and quality of original generic drug applications submitted to the Food and Drug Administration. ####
(3)Taking into account the determinations made pursuant to paragraphs
(1)and
(2)and any review process improvements implemented pursuant to this Act, whether there are ways the review process for generic drugs could be improved to increase the rate of first cycle approvals and tentative approvals for generic drug applications. In making this determination, the Comptroller General shall consider, among other things, options for increasing review efficiency and communication effectiveness. ###
(b)Completion Date Not later than the expiration of the 2-year period beginning on the date of enactment of this Act, the Comptroller General shall complete the study under subsection
(a)and submit a report describing the findings and conclusions of the study to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate. ###
(c)Definitions For purposes of this section: ####
(1)The term “GDUFA cohort year” means a fiscal year. ####
(2)The term “generic drug” means a drug that is approved or is seeking approval under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)). ####
(3)The term “generic drug application” means an abbreviated new drug application for the approval of a generic drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)). ####
(4)The term “Secretary” means the Secretary of Health and Human Services. ####
(5)#####
(A)The term “first cycle approvals and tentative approvals” means the approval or tentative approval of a generic drug application after the Food and Drug Administration’s complete review of the application and without issuance of one or more complete response letters. #####
(B)For purposes of this paragraph, the term “complete response letter” means a written communication to the sponsor of a generic drug application or holder of a drug master file from the Food and Drug Administration describing all of the deficiencies that the Administration has identified in the generic drug application (including pending amendments) or drug master file that must be satisfactorily addressed before the generic drug application can be approved. # TITLE IX ADDITIONAL PROVISIONS
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Sec. 809
GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF GENERIC MEDICINES
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