Title: Modernizing Therapeutic Equivalence Rating Determination Act
Policy area: Health

Summary:
Modernizing Therapeutic Equivalence Rating Determination Act
This bill requires the Food and Drug Administration (FDA) to provide a therapeutic equivalence rating for certain new drug applications if the applicant requests such a rating.
Upon request in the application, the FDA must provide such a rating for a new drug application that relies on information from studies not conducted by the applicant and that the applicant does not have a right to reference or use (commonly referred to as a 505(b)(2) application). The FDA must provide the rating no later than 30 days after the application's approval.
(A drug is a therapeutic equivalent of another if they produce the same clinical effect and have the same safety profile. Typically, for certain generic drugs, the FDA rates the therapeutic equivalence of that generic drug to another drug, such as the brand name version. Currently, an applicant seeking approval of a drug through a 505(b)(2) application typically only receives an equivalence rating by requesting one from the FDA in a separate petition.)


[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1463 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 1463

    To amend the Federal Food, Drug, and Cosmetic Act to modernize 
             therapeutic equivalence rating determinations.


_______________________________________________________________________


                   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 modernize 
             therapeutic equivalence rating determinations.

    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 ``Modernizing Therapeutic Equivalence 
Rating Determination Act''.

SEC. 2. THERAPEUTIC EQUIVALENCE DETERMINATIONS.

    Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)(7)(A)) is amended by adding at the end the following:
    ``(v)(I) The Secretary shall make a determination under clause 
(i)(III)--
            ``(aa) with respect to an application submitted under this 
        subsection, at the time of approval of such application or not 
        later than 30 days after the date of such approval; or
            ``(bb) with respect to an application submitted under 
        subsection (b)(2), at the time of approval of such application 
        or not later than 30 days after the date of such approval, 
        provided that the sponsor requests such a determination in the 
        original application, in a form prescribed by the Secretary.
    ``(II) When the Secretary makes a determination under clause 
(i)(III), the Secretary shall, in revisions made to the list pursuant 
to clause (ii), include such information for such drug.
    ``(III) When the Secretary makes a determination under clause 
(i)(III) with respect to a drug, the Secretary shall, at the same time, 
make such a determination with respect to any other drug--
            ``(aa) whose application under subsection (b)(2) was 
        approved;
            ``(bb) which references the same listed drug as the 
        application for the first drug for which such determination is 
        made; and
            ``(cc) for which there is a citizen petition pending 
        requesting that the Secretary make a determination under clause 
        (i)(III).''.
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