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H. Rept. 116-52 1 (2019-05-10)

handle is hein.congrecreports/crptxacim0001 and id is 1 raw text is: AUTHENTICATE
U.S. GOVERNMENT
INFORMATION
       GPO













                    116TH CONGRESS 1.1REPT. 116 52
                        1st Session    HOUSE OF REPRESENTATIVES              Part 1







                        PROTECTING CONSUMER ACCESS TO GENERIC DRUGS
                                               ACT OF 2019



                      MAY 10, 2019.-Committed to the Committee of the Whole House on the State of
                                        the Union and ordered to be printed



                       Mr. PALLONE, from the Committee on Energy and Commerce,
                                          submitted the following


                                              REPORT

                                            [To accompany H.R. 1499]

                              [Including cost estimate of the Congressional Budget Office]

                      The Committee on Energy and Commerce, to whom was referred
                    the bill (H.R. 1499) to prohibit brand name drug manufacturers
                    from compensating generic drug manufacturers to delay the entry
                    of a generic drug into the market, and to prohibit biological product
                    manufacturers from compensating biosimilar and interchangeable
                    product manufacturers to delay entry of biosimilar and inter-
                    changeable products, and for other purposes, having considered the
                    same, report   favorably  thereon   with  an  amendment    and   rec-
                    ommend that the bill as amended do pass.

                                                 CONTENTS
                                                                                     Page
                    Purpose and Sum m ary  ...........................................................................................  6
                    Background and Need for the  Legislation  .............................................................  6
                    Com m ittee  H earings  ................................................................................................  7
                    Com m ittee  Consideration  ........................................................................................  8
                    C om m ittee  V otes  ......................................................................................................  8
                    Oversight Findings  .................................................................................................  8
                    New Budget Authority, Entitlement Authority, and Tax Expenditures .............     8
                    Congressional Budget Office  Estimate   ...................................................................  8
                    Federal M andates  Statem ent  .................................................................................  12
                    Statement of General Performance Goals and Objectives ....................................  12
                    Duplication  of Federal Program s  ............................................................................  12
                    Com m ittee  Cost  Estim ate  .......................................................................................  12
                    Earmarks, Limited Tax Benefits, and Limited Tariff Benefits ...........................  12
                    Advisory Com m ittee  Statem ent  ..............................................................................  12
                    Applicability  to  Legislative  Branch  ........................................................................  12
                    Section-by-Section  Analysis of the  Legislation  ......................................................  13
                    Changes in Existing Law Made by the Bill, as Reported .....................................  15
                        89-006

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