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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2415 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2415

   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
          establishment of a streamlined data review program.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 19, 2015

Mr. Burgess (for himself and Mr. Engel) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
          establishment of a streamlined data review program.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. STREAMLINED DATA REVIEW PROGRAM.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 505F of such Act (21 U.S.C. 
355f) the following:

``SEC. 505F. STREAMLINED DATA REVIEW PROGRAM.

    ``(a) In General.--The Secretary shall establish a streamlined data 
review program under which a holder of an approved application 
submitted under section 505(b)(1) or under section 351(a) of the Public 
Health Service Act may, to support the approval or licensure (as 
applicable) of the use of the drug that is the subject of such approved 
application for a new qualified indication, submit qualified data 
summaries.
    ``(b) Eligibility.--In carrying out the streamlined data review 
program under subsection (a), the Secretary may authorize the holder of 
the approved application to include one or more qualified data 
summaries described in subsection (a) in a supplemental application 
if--
            ``(1) the drug has been approved under section 505(c) of 
        this Act or licensed under section 351(a) of the Public Health 
        Service Act for one or more indications, and such approval or 
        licensure remains in effect;
            ``(2) the supplemental application is for approval or 
        licensure (as applicable) under such section 505(c) or 351(a) 
        of the use of the drug for a new qualified indication under 
        such section 505(c) or 351(a);
            ``(3) there is an existing database acceptable to the 
        Secretary regarding the safety of the drug developed for one or 
        more indications of the drug approved under such section 505(c) 
        or licensed under such section 351(a);
            ``(4) the supplemental application incorporates or 
        supplements the data submitted in the application for approval 
        or licensure referred to in paragraph (1); and
            ``(5) the full data sets used to develop the qualified data 
        summaries are submitted, unless the Secretary determines that 
        the full data sets are not required.
    ``(c) Public Availability of Information on Program.--The Secretary 
shall post on the public website of the Food and Drug Administration 
and update annually--
            ``(1) the number of applications reviewed under the 
        streamlined data review program;
            ``(2) the average time for completion of review under the 
        streamlined data review program versus other review of 
        applications for new indications; and
            ``(3) the number of applications reviewed under the 
        streamlined data review program for which the Food and Drug 
        Administration made use of full data sets in addition to the 
        qualified data summary.
    ``(d) Definitions.--In this section:
            ``(1) The term `qualified indication' means--
                    ``(A) an indication for the treatment of cancer, as 
                determined appropriate by the Secretary; or
                    ``(B) such other types of indications as the 
                Secretary determines to be subject to the streamlined 
                data review program under this section.
            ``(2) The term `qualified data summary' means a summary of 
        clinical data intended to demonstrate safety and effectiveness 
        with respect to a qualified indication for use of a drug.''.
    (b) Sense of Congress.--It is the sense of Congress that the 
streamlined data review program under section 505F of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a), should enable the 
Food and Drug Administration to make approval decisions for certain 
supplemental applications based on qualified data summaries (as defined 
in such section 505F).
    (c) Guidance; Regulations.--The Commissioner of Food and Drugs--
            (1) shall--
                    (A) issue final guidance for implementation of the 
                streamlined data review program established under 
                section 505F of the Federal Food, Drug, and Cosmetic 
                Act, as added by subsection (a), not later than 24 
                months after the date of enactment of this Act; and
                    (B) include in such guidance the process for 
                expanding the types of indications to be subject to the 
                streamlined data review program, as authorized by 
                section 505F(c)(1)(B) of such Act; and
            (2) in addition to issuing guidance under paragraph (1), 
        may issue such regulations as may be necessary for 
        implementation of the program.
                                 <all>
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