[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1067 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 107
118th CONGRESS
  1st Session
                                S. 1067

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                           citizen petitions.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 29, 2023

  Mrs. Shaheen (for herself, Ms. Collins, Mr. Bennet, Mr. Rubio, Ms. 
 Baldwin, 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 
                           citizen petitions.

    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 ``Ensuring Timely Access to 
Generics Act of 2023''.</DELETED>

<DELETED>SEC. 2. ENSURING TIMELY ACCESS TO GENERICS.</DELETED>

<DELETED>    Section 505(q) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(q)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1)--</DELETED>
                <DELETED>    (A) in subparagraph (A)(i), by inserting 
                ``, 10.31,'' after ``10.30'';</DELETED>
                <DELETED>    (B) in subparagraph (E)--</DELETED>
                        <DELETED>    (i) by striking ``application 
                        and'' and inserting ``application 
                        or'';</DELETED>
                        <DELETED>    (ii) by striking ``If the 
                        Secretary'' and inserting the 
                        following:</DELETED>
                        <DELETED>    ``(i) In general.--If the 
                        Secretary'';</DELETED>
                        <DELETED>    (iii) by striking the second 
                        sentence and inserting the following:</DELETED>
                        <DELETED>    ``(ii) Primary purpose of 
                        delaying.--</DELETED>
                                <DELETED>    ``(I) In general.--In 
                                determining whether a petition was 
                                submitted with the primary purpose of 
                                delaying an application, the Secretary 
                                may consider the following 
                                factors:</DELETED>
                                        <DELETED>    ``(aa) Whether the 
                                        petition was submitted in 
                                        accordance with paragraph 
                                        (2)(B), based on when the 
                                        petitioner knew or reasonably 
                                        should have known the relevant 
                                        information relied upon to form 
                                        the basis of such 
                                        petition.</DELETED>
                                        <DELETED>    ``(bb) Whether the 
                                        petitioner has submitted 
                                        multiple or serial petitions or 
                                        supplements to petitions 
                                        raising issues that reasonably 
                                        could have been known to the 
                                        petitioner at the time of 
                                        submission of the earlier 
                                        petition or 
                                        petitions.</DELETED>
                                        <DELETED>    ``(cc) Whether the 
                                        petition was submitted close in 
                                        time to a known, first date 
                                        upon which an application under 
                                        subsection (b)(2) or (j) of 
                                        this section or section 351(k) 
                                        of the Public Health Service 
                                        Act could be 
                                        approved.</DELETED>
                                        <DELETED>    ``(dd) Whether the 
                                        petition was submitted without 
                                        relevant data or information in 
                                        support of the scientific 
                                        positions forming the basis of 
                                        such petition.</DELETED>
                                        <DELETED>    ``(ee) Whether the 
                                        petition raises the same or 
                                        substantially similar issues as 
                                        a prior petition to which the 
                                        Secretary has responded 
                                        substantively already, 
                                        including if the subsequent 
                                        submission follows such 
                                        response from the Secretary 
                                        closely in time.</DELETED>
                                        <DELETED>    ``(ff) Whether the 
                                        petition requests changing the 
                                        applicable standards that other 
                                        applicants are required to 
                                        meet, including requesting 
                                        testing, data, or labeling 
                                        standards that are more onerous 
                                        or rigorous than the standards 
                                        the Secretary has determined to 
                                        be applicable to the listed 
                                        drug, reference product, or 
                                        petitioner's version of the 
                                        same drug.</DELETED>
                                        <DELETED>    ``(gg) The 
                                        petitioner's record of 
                                        submitting petitions to the 
                                        Food and Drug Administration 
                                        that have been determined by 
                                        the Secretary to have been 
                                        submitted with the primary 
                                        purpose of delay.</DELETED>
                                        <DELETED>    ``(hh) Other 
                                        relevant and appropriate 
                                        factors, which the Secretary 
                                        shall describe in 
                                        guidance.</DELETED>
                                <DELETED>    ``(II) Guidance.--The 
                                Secretary may issue or update guidance, 
                                as appropriate, to describe factors the 
                                Secretary considers in accordance with 
                                subclause (I).''; and</DELETED>
                        <DELETED>    (iv) by adding at the end the 
                        following:</DELETED>
                        <DELETED>    ``(iii) Referral to the federal 
                        trade commission.--The Secretary shall 
                        establish procedures for referring to the 
                        Federal Trade Commission any petition or 
                        supplement to a petition that the Secretary 
                        determines was submitted with the primary 
                        purpose of delaying approval of an application. 
                        Such procedures shall include notification to 
                        the petitioner by the Secretary.'';</DELETED>
                <DELETED>    (C) by striking subparagraph 
                (F);</DELETED>
                <DELETED>    (D) by redesignating subparagraphs (G) 
                through (I) as subparagraphs (F) through (H), 
                respectively; and</DELETED>
                <DELETED>    (E) in subparagraph (H), as so 
                redesignated, by striking ``submission of this 
                petition'' and inserting ``submission of this 
                document'';</DELETED>
        <DELETED>    (2) in paragraph (2)--</DELETED>
                <DELETED>    (A) by redesignating subparagraphs (A) 
                through (C) as subparagraphs (C) through (E), 
                respectively;</DELETED>
                <DELETED>    (B) by inserting before subparagraph (C), 
                as so redesignated, the following:</DELETED>
                <DELETED>    ``(A) In general.--A person shall submit a 
                petition to the Secretary under paragraph (1) before 
                filing a civil action in which the person seeks to set 
                aside, delay, rescind, withdraw, or prevent submission, 
                review, or approval of an application submitted under 
                subsection (b)(2) or (j) of this section or section 
                351(k) of the Public Health Service Act. Such petition 
                and any supplement to such a petition shall describe 
                all information and arguments that form the basis of 
                the relief requested in any civil action described in 
                the previous sentence.</DELETED>
                <DELETED>    ``(B) Timely submission of citizen 
                petition.--A petition and any supplement to a petition 
                shall be submitted within 60 days after the person 
                knew, or reasonably should have known, the information 
                that forms the basis of the request made in the 
                petition or supplement.'';</DELETED>
                <DELETED>    (C) in subparagraph (C), as so 
                redesignated--</DELETED>
                        <DELETED>    (i) in the heading, by striking 
                        ``within 150 days'';</DELETED>
                        <DELETED>    (ii) in clause (i), by striking 
                        ``during the 150-day period referred to in 
                        paragraph (1)(F),''; and</DELETED>
                        <DELETED>    (iii) by amending clause (ii) to 
                        read as follows:</DELETED>
                        <DELETED>    ``(ii) on or after the date that 
                        is 151 days after the date of submission of the 
                        petition, the Secretary approves or has 
                        approved the application that is the subject of 
                        the petition without having made such a final 
                        decision.'';</DELETED>
                <DELETED>    (D) by amending subparagraph (D), as so 
                redesignated, to read as follows:</DELETED>
                <DELETED>    ``(D) Dismissal of certain civil 
                actions.--</DELETED>
                        <DELETED>    ``(i) Petition.--If a person files 
                        a civil action against the Secretary in which a 
                        person seeks to set aside, delay, rescind, 
                        withdraw, or prevent submission, review, or 
                        approval of an application submitted under 
                        subsection (b)(2) or (j) of this section or 
                        section 351(k) of the Public Health Service Act 
                        without complying with the requirements of 
                        subparagraph (A), the court shall dismiss 
                        without prejudice the action for failure to 
                        exhaust administrative remedies.</DELETED>
                        <DELETED>    ``(ii) Timeliness.--If a person 
                        files a civil action against the Secretary in 
                        which a person seeks to set aside, delay, 
                        rescind, withdraw, or prevent submission, 
                        review, or approval of an application submitted 
                        under subsection (b)(2) or (j) of this section 
                        or section 351(k) of the Public Health Service 
                        Act without complying with the requirements of 
                        subparagraph (B), the court shall dismiss with 
                        prejudice the action for failure to timely file 
                        a petition.</DELETED>
                        <DELETED>    ``(iii) Final response.--If a 
                        civil action is filed against the Secretary 
                        with respect to any issue raised in a petition 
                        timely filed under paragraph (1) in which the 
                        petitioner requests that the Secretary take any 
                        form of action that could, if taken, set aside, 
                        delay, rescind, withdraw, or prevent 
                        submission, review, or approval of an 
                        application submitted under subsection (b)(2) 
                        or (j) of this section or section 351(k) of the 
                        Public Health Service Act before the Secretary 
                        has taken final agency action on the petition 
                        within the meaning of subparagraph (C), the 
                        court shall dismiss without prejudice the 
                        action for failure to exhaust administrative 
                        remedies.''; and</DELETED>
                <DELETED>    (E) in clause (iii) of subparagraph (E), 
                as so redesignated, by striking ``as defined under 
                subparagraph (2)(A)'' and inserting ``within the 
                meaning of subparagraph (C)''; and</DELETED>
        <DELETED>    (3) in paragraph (4)--</DELETED>
                <DELETED>    (A) by striking ``Exceptions'' in the 
                paragraph heading and all that follows through ``This 
                subsection does'' and inserting ``Exceptions.--This 
                subsection does'';</DELETED>
                <DELETED>    (B) by striking subparagraph (B); 
                and</DELETED>
                <DELETED>    (C) by redesignating clauses (i) and (ii) 
                as subparagraphs (A) and (B), respectively, and 
                adjusting the margins accordingly.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Ensuring Timely Access to Generics 
Act of 2023''.

SEC. 2. ENSURING TIMELY ACCESS TO GENERICS.

    Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(q)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)(i), by inserting ``, 
                10.31,'' after ``10.30'';
                    (B) in subparagraph (E)--
                            (i) by striking ``application and'' and 
                        inserting ``application or'';
                            (ii) by striking ``If the Secretary'' and 
                        inserting the following:
                            ``(i) In general.--If the Secretary''; and
                            (iii) by striking the second sentence and 
                        inserting the following:
                            ``(ii) Primary purpose of delaying.--
                                    ``(I) In general.--In determining 
                                whether a petition was submitted with 
                                the primary purpose of delaying an 
                                application, the Secretary may consider 
                                the following factors:
                                            ``(aa) Whether the petition 
                                        was submitted in accordance 
                                        with paragraph (2)(B), based on 
                                        when the petitioner knew the 
                                        relevant information relied 
                                        upon to form the basis of such 
                                        petition.
                                            ``(bb) When the petition 
                                        was submitted in relation to 
                                        when the petitioner reasonably 
                                        should have known the relevant 
                                        information relied upon to form 
                                        the basis of such petition.
                                            ``(cc) Whether the 
                                        petitioner has submitted 
                                        multiple or serial petitions or 
                                        supplements to petitions 
                                        raising issues that reasonably 
                                        could have been known to the 
                                        petitioner at the time of 
                                        submission of the earlier 
                                        petition or petitions.
                                            ``(dd) Whether the petition 
                                        was submitted close in time to 
                                        a known, first date upon which 
                                        an application under subsection 
                                        (b)(2) or (j) of this section 
                                        or section 351(k) of the Public 
                                        Health Service Act could be 
                                        approved.
                                            ``(ee) Whether the petition 
                                        was submitted without relevant 
                                        data or information in support 
                                        of the scientific positions 
                                        forming the basis of such 
                                        petition.
                                            ``(ff) Whether the petition 
                                        raises the same or 
                                        substantially similar issues as 
                                        a prior petition to which the 
                                        Secretary has responded 
                                        substantively already, 
                                        including if the subsequent 
                                        submission follows such 
                                        response from the Secretary 
                                        closely in time.
                                            ``(gg) Whether the petition 
                                        requests changing the 
                                        applicable standards that other 
                                        applicants are required to 
                                        meet, including requesting 
                                        testing, data, or labeling 
                                        standards that are more onerous 
                                        or rigorous than the standards 
                                        the Secretary has determined to 
                                        be applicable to the listed 
                                        drug, reference product, or 
                                        petitioner's version of the 
                                        same drug.
                                            ``(hh) The petitioner's 
                                        record of submitting petitions 
                                        to the Food and Drug 
                                        Administration that have been 
                                        determined by the Secretary to 
                                        have been submitted with the 
                                        primary purpose of delay.
                                            ``(ii) Other relevant and 
                                        appropriate factors, which the 
                                        Secretary shall describe in 
                                        guidance.
                                    ``(II) Guidance.--The Secretary may 
                                issue or update guidance, as 
                                appropriate, to describe factors the 
                                Secretary considers in accordance with 
                                subclause (I).'';
                    (C) by striking subparagraph (F);
                    (D) by redesignating subparagraphs (G) through (I) 
                as subparagraphs (F) through (H), respectively; and
                    (E) in subparagraph (H), as so redesignated, by 
                striking ``submission of this petition'' and inserting 
                ``submission of this document'';
            (2) in paragraph (2)--
                    (A) by redesignating subparagraphs (A) through (C) 
                as subparagraphs (C) through (E), respectively;
                    (B) by inserting before subparagraph (C), as so 
                redesignated, the following:
                    ``(A) In general.--A person shall submit a petition 
                to the Secretary under paragraph (1) before filing a 
                civil action in which the person seeks to set aside, 
                delay, rescind, withdraw, or prevent submission, 
                review, or approval of an application submitted under 
                subsection (b)(2) or (j) of this section or section 
                351(k) of the Public Health Service Act. Such petition 
                and any supplement to such a petition shall describe 
                all information and arguments that form the basis of 
                the relief requested in any civil action described in 
                the previous sentence.
                    ``(B) Timely submission of citizen petition.--A 
                petition and any supplement to a petition shall be 
                submitted within 180 days after the person knew the 
                information that forms the basis of the request made in 
                the petition or supplement.'';
                    (C) in subparagraph (C), as so redesignated--
                            (i) in the heading, by striking ``within 
                        150 days'';
                            (ii) in clause (i), by striking ``during 
                        the 150-day period referred to in paragraph 
                        (1)(F),''; and
                            (iii) by amending clause (ii) to read as 
                        follows:
                            ``(ii) on or after the date that is 151 
                        days after the date of submission of the 
                        petition, the Secretary approves or has 
                        approved the application that is the subject of 
                        the petition without having made such a final 
                        decision.'';
                    (D) by amending subparagraph (D), as so 
                redesignated, to read as follows:
                    ``(D) Dismissal of certain civil actions.--
                            ``(i) Petition.--If a person files a civil 
                        action against the Secretary in which a person 
                        seeks to set aside, delay, rescind, withdraw, 
                        or prevent submission, review, or approval of 
                        an application submitted under subsection 
                        (b)(2) or (j) of this section or section 351(k) 
                        of the Public Health Service Act without 
                        complying with the requirements of subparagraph 
                        (A), the court shall dismiss without prejudice 
                        the action for failure to exhaust 
                        administrative remedies.
                            ``(ii) Timeliness.--If a person files a 
                        civil action against the Secretary in which a 
                        person seeks to set aside, delay, rescind, 
                        withdraw, or prevent submission, review, or 
                        approval of an application submitted under 
                        subsection (b)(2) or (j) of this section or 
                        section 351(k) of the Public Health Service Act 
                        without complying with the requirements of 
                        subparagraph (B), the court shall dismiss with 
                        prejudice the action for failure to timely file 
                        a petition.
                            ``(iii) Final response.--If a civil action 
                        is filed against the Secretary with respect to 
                        any issue raised in a petition timely filed 
                        under paragraph (1) in which the petitioner 
                        requests that the Secretary take any form of 
                        action that could, if taken, set aside, delay, 
                        rescind, withdraw, or prevent submission, 
                        review, or approval of an application submitted 
                        under subsection (b)(2) or (j) of this section 
                        or section 351(k) of the Public Health Service 
                        Act before the Secretary has taken final agency 
                        action on the petition within the meaning of 
                        subparagraph (C), the court shall dismiss 
                        without prejudice the action for failure to 
                        exhaust administrative remedies.''; and
                    (E) in clause (iii) of subparagraph (E), as so 
                redesignated, by striking ``as defined under 
                subparagraph (2)(A)'' and inserting ``within the 
                meaning of subparagraph (C)''; and
            (3) in paragraph (4)--
                    (A) by striking ``Exceptions'' in the paragraph 
                heading and all that follows through ``This subsection 
                does'' and inserting ``Exceptions.--This subsection 
                does'';
                    (B) by striking subparagraph (B); and
                    (C) by redesignating clauses (i) and (ii) as 
                subparagraphs (A) and (B), respectively, and adjusting 
                the margins accordingly.
                                                       Calendar No. 107

118th CONGRESS

  1st Session

                                S. 1067

_______________________________________________________________________

                                 A BILL

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                           citizen petitions.

_______________________________________________________________________

                             June 22, 2023

                       Reported with an amendment