Title: Expanding Access to Low-Cost Generics Act of 2021
Policy area: Health

Summary:
Expanding Access to Low-Cost Generics Act of 2021
This bill modifies provisions related to market exclusivity for a generic drug.
Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.
The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (4) no first applicant's application has been effectively approved on the date that all such conditions are met.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2910 Introduced in Senate (IS)]

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117th CONGRESS
  1st Session
                                S. 2910

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
          180-day exclusivity period, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 30, 2021

 Ms. Smith (for herself and Mr. Braun) 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 with respect to the 
          180-day exclusivity period, and for other purposes.

    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 ``Expanding Access to Low-Cost 
Generics Act of 2021''.

SEC. 2. 180-DAY EXCLUSIVITY PERIOD.

    (a) In General.--Section 505(j)(5)(B)(iv) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended--
            (1) in subclause (I), by inserting before the period at the 
        end the following: ``or an applicant whose application was 
        approved pursuant to subclause (III). If an applicant described 
        in subclause (III) is eligible for effective approval on the 
        same day a tentatively approved first applicant who has 
        requested final approval is determined by the Secretary to be 
        eligible for effective approval by meeting all the approval 
        requirements of this subsection, such applicant may not receive 
        effective approval until 180 days after the first applicant 
        begins commercial marketing of the drug.''; and
            (2) by adding at the end the following new subclause:
                    ``(III) Applicant approval.--The Secretary may 
                approve an application containing a certification 
                described in paragraph (2)(A)(vii)(IV) that is for a 
                drug for which a first applicant has submitted an 
                application containing such a certification, 
                notwithstanding the eligibility of a first applicant 
                for the 180-day exclusivity period described in 
                subclause (II)(aa), if each of the following conditions 
                is met:
                            ``(aa) The approval of such application 
                        could be made effective, but for the 
                        eligibility of a first applicant for 180-day 
                        exclusivity under this clause.
                            ``(bb) At least 30 months have passed since 
                        the date of submission of an application for 
                        the drug by at least one first applicant.
                            ``(cc) Approval of an application for the 
                        drug submitted by at least one first applicant 
                        is not precluded under clause (iii).
                            ``(dd) No application for the drug 
                        submitted by any first applicant is effectively 
                        approved on the date that the conditions under 
                        items (aa), (bb), and (cc) are all met, 
                        regardless of whether such application is 
                        subsequently approved.''.
    (b) Applicability.--The amendments made by subsection (a) shall 
apply only with respect to an application filed under section 505(j) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the 
date of enactment of this Act that identifies a listed drug for which 
no certification under paragraph (2)(A)(vii)(IV) of such section was 
made before such date of enactment.
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