[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1114 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 108
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

                             June 22, 2023

               Reported by Mr. Sanders, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Expanding Access to Low-
Cost Generics Act of 2023''.</DELETED>

<DELETED>SEC. 2. 180-DAY EXCLUSIVITY PERIOD.</DELETED>

<DELETED>    (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--
</DELETED>
        <DELETED>    (1) in subclause (I)--</DELETED>
                <DELETED>    (A) by inserting ``and subclause (III)'' 
                after ``subparagraph (D)''; and</DELETED>
                <DELETED>    (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</DELETED>
        <DELETED>    (2) by adding at the end the following new 
        subclause:</DELETED>
                <DELETED>    ``(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:</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(cc) At least 33 months have 
                        passed since the date of submission of an 
                        application for the drug by at least one first 
                        applicant.</DELETED>
                        <DELETED>    ``(dd) Approval of an application 
                        for the drug submitted by at least one first 
                        applicant is not precluded under clause 
                        (iii).</DELETED>
                        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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:</DELETED>
                <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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.</DELETED>

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) shall 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 its 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.

SEC. 3. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.

    (a) In General.--Section 505(j)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the 
following:
    ``(H)(i) Upon request (in controlled correspondence or an analogous 
process) by a person that has submitted or intends to submit an 
abbreviated application under this subsection for a drug that is 
required by regulation to contain one or more of the same inactive 
ingredients in the same concentration as the listed drug referred to, 
or for which the Secretary determines there is a scientific 
justification for an approach that is in vitro, in whole or in part, to 
be used to demonstrate bioequivalence for a drug if such a drug 
contains one or more of the same inactive ingredients in the same 
concentration as the listed drug referred to, or on the Secretary's own 
initiative during the review of an application under this subsection 
for such a drug, the Secretary shall inform the person whether such 
drug is qualitatively and quantitatively the same as the listed drug.
    ``(ii) Notwithstanding section 301(j), if the Secretary determines 
that such drug is not qualitatively or quantitatively the same as the 
listed drug, the Secretary shall identify and disclose to the person--
            ``(I) the ingredient or ingredients that cause the drug not 
        to be qualitatively or quantitatively the same as the listed 
        drug; and
            ``(II) for any ingredient for which there is an identified 
        quantitative deviation, the amount of such deviation.
    ``(iii) If the Secretary determines that such drug is qualitatively 
and quantitatively the same as the listed drug, the Secretary shall not 
change or rescind such determination after the submission of an 
abbreviated application for such drug under this subsection unless--
            ``(I) the formulation of the listed drug has been changed 
        and the Secretary has determined that the prior listed drug 
        formulation was withdrawn for reasons of safety or 
        effectiveness; or
            ``(II) the Secretary makes a written determination that the 
        prior determination must be changed because an error has been 
        identified.
    ``(iv) If the Secretary makes a written determination described in 
clause (iii)(II), the Secretary shall provide notice and a copy of the 
written determination to the person making the request under clause 
(i).
    ``(v) Except as set forth in clauses (i) and (ii), nothing in this 
subparagraph shall be construed to authorize the disclosure of 
nonpublic qualitative or quantitative information about the ingredients 
in a listed drug, or to affect the status, if any, of such information 
as trade secret or confidential commercial information for purposes of 
section 301(j) of this Act, section 552 of title 5, United States Code, 
or section 1905 of title 18, United States Code.''.
    (b) Guidance.--
            (1) In general.--Not later than one year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall issue draft guidance, or update guidance, 
        describing how the Secretary will determine whether a drug is 
        qualitatively and quantitatively the same as the listed drug 
        (as such terms are used in section 505(j)(3)(H) of the Federal 
        Food, Drug, and Cosmetic Act, as added by subsection (a)), 
        including with respect to assessing pH adjusters.
            (2) Process.--In issuing guidance under this subsection, 
        the Secretary of Health and Human Services shall--
                    (A) publish draft guidance;
                    (B) provide a period of at least 60 days for 
                comment on the draft guidance; and
                    (C) after considering any comments received and not 
                later than one year after the close of the comment 
                period on the draft guidance, publish final guidance.
    (c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a), applies beginning on the 
date of enactment of this Act, irrespective of the date on which the 
guidance required by subsection (b) is finalized.
                                                       Calendar No. 108

118th CONGRESS

  1st Session

                                S. 1114

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                             June 22, 2023

                       Reported with an amendment