Expanding Access to Low-Cost Generics Act of 2023

Subjects: Health, Drug safety, medical device, and laboratory regulation, Prescription drugs


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1114 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                S. 1114

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 30, 2023

 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.

    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 2023''.

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)--
                    (A) by inserting ``and subclause (III)'' after 
                ``subparagraph (D)''; and
                    (B) 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 
                described in subclause (III) 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) The applicant of such application 
                        has submitted a certification to the 
                        abbreviated new drug application that there are 
                        no conditions that would prevent the applicant 
                        from commercial marketing within 75 days after 
                        the date of approval and that the applicant 
                        intends to so market the drug.
                            ``(cc) At least 33 months have passed since 
                        the date of submission of an application for 
                        the drug by at least one first applicant.
                            ``(dd) Approval of an application for the 
                        drug submitted by at least one first applicant 
                        is not precluded under clause (iii).
                            ``(ee) No application for the drug 
                        submitted by any first applicant is effectively 
                        approved on the date that the conditions under 
                        items (aa), (bb), (cc), and (dd) are all met 
                        and maintained.''.
    (b) Special Approval Status Rule for Certain Subsequent 
Applicants.--Section 505(j)(5)(D) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355 (j)(5)(D)) is amended at the end by adding 
the following:
                    ``(v) Special approval status rule for certain 
                subsequent applicants.--An application that is approved 
                pursuant to subclause (III) of subparagraph (B)(iv) is 
                deemed to be tentatively approved and to no longer have 
                an effective approval pursuant to such subclause (III) 
                on the date that is 76 days after the date on which the 
                approval has been made effective pursuant to such 
                subclause (III) if the applicant fails to commercially 
                market such drug within the 75-day period after the 
                date on which the approval is made effective. If the 
                applicant of an application approved pursuant to such 
                subclause (III) submits a notification that it can no 
                longer commence commercial marketing within 75 days 
                after the date of approval, as required under 
                subparagraph (B)(iv)(III)(bb), its application is 
                deemed to be tentatively approved and to no longer be 
                effectively approved on the date that such a 
                notification is received. If an applicant does not 
                commence commercial marketing within the 75-day period, 
                it shall not be eligible for a subsequent effective 
                approval for the application under subclause (III) of 
                subparagraph (B)(iv) unless, in addition to meeting 
                each of the conditions in such subclause (III), it 
                submits a certification to its abbreviated new drug 
                application that an event that could not have been 
                reasonably foreseen by the applicant prevented it from 
                commencing commercial marketing and that it has fully 
                resolved this issue. The applicant shall submit 
                notification to the abbreviated new drug application 
                confirming that such applicant has commenced commercial 
                marketing of the drug not later than one business day 
                after commencing such marketing.''.
    (c) Applicability.--The amendments made by subsections (a) and (b) 
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 505(j) was made before such date of enactment.
                                 &lt;all&gt;
</pre></body></html>