[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2476 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  2d Session
                                S. 2476

To amend the Federal Food, Drug, and Cosmetic Act to ensure that valid 
                  generic drugs may enter the market.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 28, 2018

   Ms. Smith 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 to ensure that valid 
                  generic drugs may enter the market.

    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 Generic 
Drugs Act''.

SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING FIRST APPLICANT 
              STATUS.

    (a) Amendments to Federal Food, Drug, and Cosmetic Act.--
            (1) In general.--Section 505(j)(5)(B) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) is amended--
                    (A) in clause (iv)(II)--
                            (i) by striking item (bb); and
                            (ii) by redesignating items (cc) and (dd) 
                        as items (bb) and (cc), respectively;
                    (B) by redesignating clause (v) as clause (ix); and
                    (C) by inserting after clause (iv) the following:
            ``(v) First applicant defined.--As used in this subsection, 
        the term `first applicant' means an applicant--
                    ``(I)(aa) that, on the first day on which a 
                substantially complete application containing a 
                certification described in paragraph (2)(A)(vii)(IV) is 
                submitted for approval of a drug, submits a 
                substantially complete application that contains and 
                lawfully maintains a certification described in 
                paragraph (2)(A)(vii)(IV) for the drug; and
                    ``(bb) that has not entered into a disqualifying 
                agreement described under clause (vii)(II); or
                    ``(II)(aa) for the drug that is not described in 
                subclause (I) and that, with respect to the applicant 
                and drug, each requirement described in clause (vi) is 
                satisfied; and
                    ``(bb) that has not entered into a disqualifying 
                agreement described under clause (vii)(II).
            ``(vi) Requirement.--The requirements described in this 
        clause are the following:
                    ``(I) The applicant described in clause (v)(II) 
                submitted and lawfully maintains a certification 
                described in paragraph (2)(A)(vii)(IV) or a statement 
                described in paragraph (2)(A)(viii) for each unexpired 
                patent for which a first applicant described in clause 
                (v)(I) had submitted a certification described in 
                paragraph (2)(A)(vii)(IV) on the first day on which a 
                substantially complete application containing such a 
                certification was submitted.
                    ``(II) With regard to each such unexpired patent 
                for which the applicant described in clause (v)(II) 
                submitted a certification described in paragraph 
                (2)(A)(vii)(IV), no action for patent infringement was 
                brought against such applicant within the 45-day period 
                specified in clause (iii); or if an action was brought 
                within such time period, such an action was withdrawn 
                or dismissed by a court (including a district court) 
                without a decision that the patent was valid and 
                infringed; or if an action was brought within such time 
                period and was not withdrawn or so dismissed, such 
                applicant has obtained the decision of a court 
                (including a district court) that the patent is invalid 
                or not infringed (including any substantive 
                determination that there is no cause of action for 
                patent infringement or invalidity, and including a 
                settlement order or consent decree signed and entered 
                by the court stating that the patent is invalid or not 
                infringed).
                    ``(III) If an applicant described in clause (v)(I) 
                has begun commercial marketing of such drug, the 
                applicant described in clause (v)(II) does not begin 
                commercial marketing of such drug until the date that 
                is 30 days after the date on which the applicant 
                described in clause (v)(I) began such commercial 
                marketing.''.
            (2) Conforming amendment.--Section 505(j)(5)(D)(i)(IV) of 
        such Act (21 U.S.C. 355(j)(5)(D)(i)(IV)) is amended by striking 
        ``The first applicant'' and inserting ``The first applicant, as 
        defined in subparagraph (B)(v)(I),''.
    (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)) to which 
the amendments made by section 1102(a) of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173) 
apply.

SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING AGREEMENTS TO 
              DEFER COMMERCIAL MARKETING.

    (a) Amendments to Federal Food, Drug, and Cosmetic Act.--
            (1) Limitations on agreements to defer commercial marketing 
        date.--Section 505(j)(5)(B) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(j)(5)(B)), as amended by section 2, 
        is further amended by adding at the end the following:
            ``(vii) Agreement by first applicant to defer commercial 
        marketing; limitation on acceleration of deferred commercial 
        marketing date.--
                    ``(I) Agreement to defer approval or commercial 
                marketing date.--An agreement described in this 
                subclause is an agreement between a first applicant and 
                the holder of the application for the listed drug or an 
                owner of one or more of the patents as to which any 
                applicant submitted a certification qualifying such 
                applicant for the 180-day exclusivity period whereby 
                that applicant agrees, directly or indirectly, (aa) not 
                to seek an approval of its application that is made 
                effective on the earliest possible date under this 
                subparagraph, subparagraph (F) of this paragraph, 
                section 505A, or section 527, (bb) not to begin the 
                commercial marketing of its drug on the earliest 
                possible date after receiving an approval of its 
                application that is made effective under this 
                subparagraph, subparagraph (F) of this paragraph, 
                section 505A, or section 527, or (cc) to both items 
                (aa) and (bb).
                    ``(II) Agreement that disqualifies applicant from 
                first applicant status.--An agreement described in this 
                subclause is an agreement between an applicant and the 
                holder of the application for the listed drug or an 
                owner of one or more of the patents as to which any 
                applicant submitted a certification qualifying such 
                applicant for the 180-day exclusivity period whereby 
                that applicant agrees, directly or indirectly, not to 
                seek an approval of its application or not to begin the 
                commercial marketing of its drug until a date that is 
                after the expiration of the 180-day exclusivity period 
                awarded to another applicant with respect to such drug 
                (without regard to whether such 180-day exclusivity 
                period is awarded before or after the date of the 
                agreement).
            ``(viii) Limitation on acceleration.--If an agreement 
        described in clause (vii)(I) includes more than 1 possible date 
        when an applicant may seek an approval of its application or 
        begin the commercial marketing of its drug--
                    ``(I) the applicant may seek an approval of its 
                application or begin such commercial marketing on the 
                date that is the earlier of--
                            ``(aa) the latest date set forth in the 
                        agreement on which that applicant can receive 
                        an approval that is made effective under this 
                        subparagraph, subparagraph (F) of this 
                        paragraph, section 505A, or section 527, or 
                        begin the commercial marketing of such drug, 
                        without regard to any other provision of such 
                        agreement pursuant to which the commercial 
                        marketing could begin on an earlier date; or
                            ``(bb) 180 days after another first 
                        applicant begins commercial marketing of such 
                        drug; and
                    ``(II) the latest date set forth in the agreement 
                on which that applicant can receive an approval that is 
                made effective under this subparagraph, subparagraph 
                (F) of this paragraph, section 505A, or section 527, or 
                begin the commercial marketing of such drug, without 
                regard to any other provision of such agreement 
                pursuant to which commercial marketing could begin on 
                an earlier date, shall be the date used to determine 
                whether an applicant is disqualified from first 
                applicant status pursuant to clause (vii)(II).''.
            (2) Notification of fda.--Section 505(j) of such Act (21 
        U.S.C. 355(j)) is amended by adding at the end the following:
    ``(14)(A) The holder of an abbreviated application under this 
subsection shall submit to the Secretary a notification that includes--
            ``(i)(I) the text of any agreement entered into by such 
        holder described under paragraph (5)(B)(vii)(I); or
            ``(II) if such an agreement has not been reduced to text, a 
        written detailed description of such agreement that is 
        sufficient to disclose all the terms and conditions of the 
        agreement; and
            ``(ii) the text, or a written detailed description in the 
        event of an agreement that has not been reduced to text, of any 
        other agreements that are contingent upon, provide a contingent 
        condition for, or are otherwise related to an agreement 
        described in clause (i).
    ``(B) The notification described under subparagraph (A) shall be 
submitted not later than 10 business days after execution of the 
agreement described in subparagraph (A)(i). Such notification is in 
addition to any notification required under section 1112 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
    ``(C) Any information or documentary material filed with the 
Secretary pursuant to this paragraph shall be exempt from disclosure 
under section 552 of title 5, United States Code, and no such 
information or documentary material may be made public, except as may 
be relevant to any administrative or judicial action or proceeding. 
Nothing in this paragraph is intended to prevent disclosure to either 
body of the Congress or to any duly authorized committee or 
subcommittee of the Congress.''.
            (3) Prohibited acts.--Section 301(e) of such Act (21 U.S.C. 
        331(e)) is amended by striking ``505 (i) or (k)'' and inserting 
        ``505 (i), (j)(14), or (k)''.
    (b) Infringement of Patent.--Section 271(e) of title 35, United 
States Code, is amended by adding at the end the following:
    ``(7) The exclusive remedy under this section for an infringement 
of a patent for which the Secretary of Health and Human Services has 
published information pursuant to subsection (b)(1) or (c)(2) of 
section 505 of the Federal Food, Drug, and Cosmetic Act shall be an 
action brought under this subsection within the 45-day period described 
in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the Federal 
Food, Drug, and Cosmetic Act.''.
    (c) Applicability.--
            (1) Limitations on acceleration of deferred commercial 
        marketing date.--The amendment made by subsection (a)(1) shall 
        apply only with respect to--
                    (A) an application filed under section 505(j) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(j)) to which the amendments made by section 1102(a) 
                of the Medicare Prescription Drug, Improvement, and 
                Modernization Act of 2003 (Public Law 108-173) apply; 
                and
                    (B) an agreement described under section 
                505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and 
                Cosmetic Act (as added by subsection (a)(1)) executed 
                after the date of enactment of this Act.
            (2) Notification of fda.--The amendments made by paragraphs 
        (2) and (3) of subsection (a) shall apply only with respect to 
        an agreement described under section 505(j)(5)(B)(vii)(I) of 
        the Federal Food, Drug, and Cosmetic Act (as added by 
        subsection (a)(1)) executed after the date of enactment of this 
        Act.
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