Title: Simplifying the Generic Drug Application Process Act
Policy area: Health

Summary:
Simplifying the Generic Drug Application Process Act
This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug.
Currently, if an applicant wishes to submit an abbreviated application (i.e., the type of application typically used to get market approval for a generic drug) for a drug that has a different dosage form or strength from an already-approved drug, the applicant must first petition the FDA for permission to submit the application. Under this bill, an applicant is no longer required to petition the FDA for permission in these instances.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1462 Introduced in Senate (IS)]

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117th CONGRESS
  1st Session
                                S. 1462

   To amend the Federal Food, Drug, and Cosmetic Act to simplify the 
                   generic drug application process.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 29, 2021

Mr. Cassidy (for himself and Ms. Smith) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to simplify the 
                   generic drug application process.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Simplifying the Generic Drug 
Application Process Act''.

SEC. 2. SUBMISSION FOR SUITABILITY.

    Subparagraph (C) of section 505(j)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(2)) is amended to read as follows:
    ``(C) Submission for Suitability Determinations.--
            ``(i) In general.--A person may submit an abbreviated 
        application for a new drug that has a different dosage form or 
        strength from that of a listed drug.
            ``(ii) Secretary's determination on submission.--The 
        Secretary shall approve or disapprove the submission of such an 
        abbreviated application during the course of its determination 
        whether to receive the application pursuant to section 314.101 
        of title 21, Code of Federal Regulations (or any successor 
        regulations).
            ``(iii) Approval of submission.--The Secretary shall 
        approve the submission of such an abbreviated application, 
        provided the application is otherwise determined to be eligible 
        to be received, unless the Secretary finds that--
                    ``(I) clinical investigations are required to be 
                conducted to show the safety and effectiveness of the 
                drug or of any of its dosage forms or strengths which 
                differ from the listed drug; or
                    ``(II) any of the proposed changes from the listed 
                drug would jeopardize the safe or effective use of the 
                product so as to necessitate significant labeling 
                changes to address the newly introduced safety or 
                effectiveness problem.
            ``(iv) Disapproval of submission.--If the Secretary 
        disapproves the submission of an abbreviated application under 
        this subparagraph, the application shall be considered not to 
        have been received within the meaning of paragraph (5)(A).''.
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