119-hr1051

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1051 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 1051

 To amend the Federal Food, Drug, and Cosmetic Act to allow for the 
 approval of an abbreviated new drug application submitted by a 
 subsequent applicant in the case of a failure by a first applicant to 
 commence commercial marketing within a certain period, and for other 
 purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 February 6, 2025

Ms. Budzinski 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 allow for the 
 approval of an abbreviated new drug application submitted by a 
 subsequent applicant in the case of a failure by a first applicant to 
 commence commercial marketing within a certain 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. 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 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 Forfeiture 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 by adding at the end the following:
 ``
            (v) Special forfeiture rule for certain 
 subsequent applicants.--
 ``
            (I) In general.--Except as 
 specified in subclause
            (II) , 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) beginning on the day 
 after the end of the 75-day period 
 specified in item

    (bb) of such 
 subclause
            (III) if the applicant fails 
 to commence commercial marketing as 
 required under such item.
 ``
            (II) Opportunity to cure.--
 ``

    (aa) In general.--If the 
 applicant of an application 
 approved pursuant to subclause
            (III) of subparagraph
        (B)
            (iv) submits, pursuant to item

    (bb) of such subclause, a 
 notification that it can no 
 longer commence commercial 
 marketing within the 75-day 
 period specified in such item, 
 such application is deemed to 
 be tentatively approved and to 
 no longer be effectively 
 approved beginning on the date 
 that such a notification is 
 received.
 ``

    (bb) Ineligibility for 
 subsequent effective 
 approval.--If an applicant 
 described in item

    (aa) does not 
 commence commercial marketing 
 within such 75-day period, the 
 applicant shall not be eligible 
 for a subsequent effective 
 approval for the application 
 involved under subclause
            (III) of subparagraph
        (B)
            (iv) unless, 
 in addition to meeting each of 
 the conditions in such 
 subclause
            (III) , the applicant 
 submits a certification to its 
 abbreviated new drug 
 application that--

 ``

    (AA) an event 
 that could not have 
 been reasonably 
 foreseen by the 
 applicant prevented it 
 from commencing 
 commercial marketing; 
 and

 ``

    (BB) it has fully 
 resolved any issues 
 preventing such 
 commercial marketing 
 from commencing as a 
 result of such event.

 ``
            (cc) Timing for 
 submission.--An applicant 
 described in item

    (aa) shall, 
 not later than one business day 
 after commencing marketing of 
 the drug that is the subject of 
 the application described in 
 such item, submit a 
 notification to the abbreviated 
 new drug application confirming 
 that such applicant has 
 commenced commercial marketing 
 of the drug.''.
            (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 was made before such date of enactment.
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