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Title II — Reducing the Prices of Prescription Drugs

S. 1895 · 116th Congress · Jun 19, 2019 · Lineage

II Reducing the Prices of Prescription Drugs

Sec. 201 Biological product patent transparency

(a)
In general— Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding at the end the following:

“(o) Additional requirements with respect to patents

“(1) Approved application holder listing requirements

“(A) In general—Beginning on the date of enactment of the Lower Health Care Costs Act, within 60 days of approval of an application under subsection (a) or (k), the holder of such approved application shall submit to the Secretary a list of each patent required to be disclosed (as described in paragraph (3)).

“(B) Previously approved or licensed biological products

“(i) Products licensed under section 351 of the PHSA—Not later than 30 days after the date of enactment of the Lower Health Care Costs Act, the holder of a biological product license that was approved under subsection (a) or (k) before the date of enactment of such Act shall submit to the Secretary a list of each patent required to be disclosed (as described in paragraph (3)).

“(ii) Products approved under section 505 of the FFDCA—Not later than 30 days after March 23, 2020, the holder of an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act that is deemed to be a license for the biological product under this section on March 23, 2020, shall submit to the Secretary a list of each patent required to be disclosed (as described in paragraph (3)).

“(C) Updates—The holder of a biological product license that is the subject of an application under subsection (a) or (k) shall submit to the Secretary a list that includes—

“(i) any patent not previously required to be disclosed (as described in paragraph (3)) under subparagraph (A) or (B), as applicable, within 30 days of the earlier of—

“(I) the date of issuance of such patent by the United States Patent and Trademark Office; or

“(II) the date of approval of a supplemental application for the biological product; and

“(ii) any patent, or any claim with respect to a patent, included on the list pursuant to this paragraph, that the Patent Trial and Appeal Board of the United States Patent and Trademark Office determines in a decision to be invalid or unenforceable, within 30 days of such decision.

“(2) Publication of information

“(A) In general—Within 1 year of the date of enactment of the Lower Health Care Costs Act, the Secretary shall publish and make available to the public a single, easily searchable, list that includes—

“(i) the official and proprietary name of each biological product licensed under subsection (a) or (k), and of each biological product application approved under section 505 of the Federal Food, Drug, and Cosmetic Act and deemed to be a license for the biological product under this section on March 23, 2020;

“(ii) with respect to each biological product described in clause (i), each patent submitted in accordance with paragraph (1);

“(iii) the date of approval and application number for each such biological product;

“(iv) the marketing status, dosage form, route of administration, strength, and, if applicable, reference product, for each such biological product;

“(v) the licensure status for each such biological product, including whether the license at the time of listing is approved, withdrawn, or revoked;

“(vi) with respect to each such biological product, any period of any exclusivity under paragraph (6), (7)(A), or (7)(B) of subsection (k) of this section or section 527 of the Federal Food, Drug, and Cosmetic Act, and any extension of such period in accordance with subsection (m) of this section, for which the Secretary has determined such biological product to be eligible, and the date on which such exclusivity expires;

“(vii) information regarding any determination of biosimilarity or interchangeability for each such biological product; and

“(viii) information regarding approved indications for each such biological product, in such manner as the Secretary determines appropriate.

“(B) Updates—Every 30 days after the publication of the first list under subparagraph (A), the Secretary shall revise the list to include—

“(i)

“(I) each biological product licensed under subsection (a) or (k) during the 30-day period; and

“(II) with respect to each biological product described in subclause (I), the information described in clauses (i) through (viii) of subparagraph (A); and

“(ii) any updates to information previously published in accordance with subparagraph (A).

“(C) Noncompliance—Beginning 18 months after the date of enactment of the Lower Health Care Costs Act, the Secretary, in consultation with the Director of the United States Patent and Trademark Office, shall publish and make available to the public a list of any holders of biological product licenses, and the corresponding biological product or products, that failed to submit information as required under paragraph (1), including any updates required under paragraph (1)(C), in such manner and format as the Secretary determines appropriate. If information required under paragraph (1) is submitted following publication of such list, the Secretary shall remove such holders of such biological product licenses from the public list in a reasonable period of time.

“(3) Patents required to be disclosed—In this section, a patent required to be disclosed is any patent for which the holder of a biological product license approved under subsection (a) or (k), or a biological product application approved under section 505 of the Federal Food, Drug, and Cosmetic Act and deemed to be a license for a biological product under this section on March 23, 2020, believes a claim of patent infringement could reasonably be asserted by the holder, or by a patent owner that has granted an exclusive license to the holder with respect to the biological product that is the subject of such license, if a person not licensed by the holder engaged in the making, using, offering to sell, selling, or importing into the United States of the biological product that is the subject of such license.”

(b)
Disclosure of patents— Section 351(l)(3)(A)(i) of the Public Health Service Act (42 U.S.C. 262(l)(3)(A)(i)) is amended by inserting “included in the list provided by the reference product sponsor under subsection (o)(1)” after “a list of patents”.
(c)
Review and Report on Noncompliance— Not later than 30 months after the date of enactment of this Act, the Secretary shall—
(1)
solicit public comments regarding appropriate remedies, in addition to the publication of the list under subsection (o)(2)(C) of section 351 of the Public Health Service Act (42 U.S.C. 262), as added by subsection (a), with respect to holders of biological product licenses who fail to timely submit information as required under subsection (o)(1) of such section 351, including any updates required under subparagraph (C) of such subsection (o)(1); and
(2)
submit to Congress an evaluation of comments received under paragraph (1) and the recommendations of the Secretary concerning appropriate remedies.
(d)
Regulations— The Secretary of Health and Human Services may promulgate regulations to carry out subsection (o) of section 351 of the Public Health Service Act (42 U.S.C. 262), as added by subsection (a).
(e)
Rule of construction— Nothing in this Act, including an amendment made by this Act, shall be construed to require or allow the Secretary of Health and Human Services to delay the licensing of a biological product under section 351 of the Public Health Service Act (42 U.S.C. 262).

Sec. 202 Orange book modernization

(a)
Submission of patent information for brand name drugs—
(1)
In general— Paragraph (1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended to read as follows:

“(b)

“(1)

“(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—

“(i) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use;

“(ii) a full list of the articles used as components of such drug;

“(iii) a full statement of the composition of such drug;

“(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;

“(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;

“(vi) specimens of the labeling proposed to be used for such drug;

“(vii) any assessments required under section 505B; and

“(viii) the patent number and expiration date, of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug, and that—

“(I) claims the drug for which the applicant submitted the application and is a drug substance patent or a drug product patent; or

“(II) claims the method of using the drug for which approval is sought or has been granted in the application.

“(B) If an application is filed under this subsection for a drug, and a patent of the type described in subparagraph (A)(viii) that claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include such patent information.

“(C) Upon approval of the application, the Secretary shall publish the information submitted under subparagraph (A)(viii).”

(2)
Guidance— The Secretary of Health and Human Services shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required under subsection (b)(1)(A)(i) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by paragraph (1).
(b)
Conforming changes to requirements for subsequent submission of patent information— Section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended—
(1)
by inserting before the first sentence the following: “Not later than 30 days after the date of approval of an application under subsection (b), the holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subclause (I) or (II) of subsection (b)(1)(A)(viii), except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application. The holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subclause (I) or (II) of subsection (b)(1)(A)(viii) that is issued after the date of approval of the application, not later than 30 days of the date of issuance of the patent, except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application.”;
(2)
by inserting after “the patent number and the expiration date of any patent which” the following: “fulfills the criteria in subsection (b) and”;
(3)
by inserting after the third sentence (as amended by paragraph (1)) the following: “Patent information that is not the type of patent information required by subsection (b)(1)(A)(viii) shall not be submitted under this paragraph.”; and
(4)
by inserting after “could not file patent information under subsection (b) because no patent ” the following: “of the type required to be submitted in subsection (b)”.
(c)
Listing of exclusivities— Subparagraph (A) of section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at the end the following:

“(iv) For each drug included on the list, the Secretary shall specify any exclusivity period that is applicable, for which the Secretary has determined the expiration date, and for which such period has not yet expired under—

“(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E) of this section;

“(II) clause (iv) or (v) of paragraph (5)(B) of this subsection;

“(III) clause (ii), (iii), or (iv) of paragraph (5)(F) of this subsection;

“(IV) section 505A;

“(V) section 505E;

“(VI) section 527(a); or

“(VII) section 505(u)”

(d)
Orange book updates with respect to invalidated patents—
(1)
In general—
(A)
Amendments— Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)), as amended by subsection (c), is further amended by adding at the end the following:

“(v) In the case of a listed drug for which the list under clause (i) includes a patent or patent claim for the drug, or a patent or a patent claim for the use of such drug, and where the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office has canceled any claim of the patent relating to such drug or such use pursuant to a decision by the Patent Trial and Appeal Board in an inter partes review conducted under chapter 31 of title 35, United States Code, or a post-grant review conducted under chapter 32 of that title, and from which no appeal has been taken, or can be taken, the holder of the applicable approved application shall notify the Secretary, in writing, within 14 days of such cancellation, and, if the patent has been deemed wholly inoperative or invalid, or if a patent claim has been canceled, the revisions required under clause (iii) shall include striking the patent or information regarding such patent claim from the list with respect to such drug.”

(B)
Application— The amendment made by subparagraph (A) shall not apply with respect to any determination with respect to a patent or patent claim that is made prior to the date of enactment of this Act.
(2)
No effect on first applicant exclusivity period— Section 505(j)(5)(B)(iv)(I) is amended by adding at the end the following: “This subclause shall apply even if a patent is stricken from the list under paragraph (7)(A), pursuant to paragraph (7)(A)(v), provided that, at the time that the first applicant submitted an application under this subsection containing a certification described in paragraph (2)(A)(vii)(IV), the patent that was the subject of such certification was included in such list with respect to the listed drug.”.

Sec. 203 Ensuring timely access to generics

Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)) 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”

(iii)
by striking the second sentence and inserting the following:

“(ii) Primary purpose of delaying

“(I) In general—For purposes of this subparagraph, a petition or supplement to a petition may be considered to be submitted with the primary purpose of delaying an application under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act, if the petitioner has the purpose of setting aside, delaying, rescinding, withdrawing, or preventing submission, review, or the approval of such an application.

“(II) Factors—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 or reasonably should have known the relevant information relied upon to form the basis of such petition.

“(bb) Whether the petitioner has submitted multiple or serial petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions.

“(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.

“(dd) Whether the petition was submitted without any relevant data or information in support of the scientific positions forming the basis of such petition.

“(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.

“(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 applicable to the listed drug, reference product, or petitioner’s version of the same drug.

“(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.

“(hh) Other relevant and appropriate factors, which the Secretary shall describe in guidance.

“(III) Guidance—The Secretary may issue or update guidance, as appropriate, to describe factors the Secretary considers in accordance with subclause (II).”

(C)
by adding at the end the following:

“(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 and an opportunity for judicial review after the issuance of an order by the Federal Trade Commission.”

(D)
by striking subparagraph (F);
(E)
by redesignating subparagraphs (G) through (I) as subparagraphs (F) through (H), respectively; and
(F)
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 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.”

(C)
in subparagraph (C), as so redesignated, by—
(i)
in the heading, striking “within 150 days”;
(ii)
in clause (i), striking “during the 150-day period referred to in paragraph (1)(F),”; and
(iii)
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 issued a final response to any such petition submitted, the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.”

(E)
in subparagraph (E), as so redesignated—
(i)
in clause (ii), by striking “, if issued”; and
(ii)
in clause (iii), by striking “final agency action as defined under subparagraph (2)(A)” and inserting “the final response to the petitioner”; and
(3)
in paragraph (4)—
(A)
by striking “Exceptions” 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.

Sec. 204 Protecting access to biological products

Section 351(k)(7) of the Public Health Service Act (42 U.S.C. 262(k)(7)) is amended by adding at the end the following:

“(D) Deemed licenses

“(i) No additional exclusivity through deeming—An approved application that is deemed to be a license for a biological product under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a) for purposes of subparagraphs (A) and (B).

“(ii) Limitation on exclusivity—Subparagraph (C) shall apply to any reference product, without regard to whether—

“(I) such product was first licensed under subsection (a); or

“(II) the approved application for such product was deemed to be a license for a biological product as described in clause (i).

“(iii) Applicability—Any unexpired period of exclusivity under section 527 or section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act with respect to a biological product shall continue to apply to such biological product after an approved application for the biological product is deemed to be a license for the biological product as described in clause (i).”

Sec. 205 Preventing blocking of generic drugs

Section 505(j)(5)(B)(iv)(I) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)(I)) is amended—
(1)
by striking “180 days after the date” and inserting “180 days after the earlier of the following:

“(aa) The date”

(2)
by adding at the end the following:

“(bb) The date on which all of the following conditions are first met:

“(AA) An application for the drug submitted by an applicant other than a first applicant could receive approval, if no first applicant were eligible for 180-day exclusivity under this clause.

“(BB) Thirty-three months have passed since the date of submission of an application for the drug by one first applicant, if there is only one first applicant, or, in the case of more than one first applicant, 33 months have passed since the date of submission of all such applications.

“(CC) Approval of an application for the drug submitted by at least one first applicant would not be precluded under clause (iii).

“(DD) No application for the drug submitted by any first applicant is approved at the time the conditions under subitems (AA), (BB), and (CC) are all met, regardless of whether such an application is subsequently approved.”

Sec. 206 Education on biological products

Subpart 1 of part F of title III of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended by adding at the end the following:

“352A. Education on biological products

“(a) Internet website

“(1) In general—The Secretary may establish, maintain, and operate an internet website to provide educational materials for health care providers, patients, and caregivers, regarding the meaning of the terms, and the standards for review and licensing of, biological products, including biosimilar biological products and interchangeable biosimilar biological products.

“(2) Content—Educational materials provided under paragraph (1) may include explanations of—

“(A) key statutory and regulatory terms, including biosimilar and interchangeable, and clarification regarding the appropriate use of interchangeable biosimilar biological products;

“(B) information related to development programs for biological products, including biosimilar biological products and interchangeable biosimilar biological products and relevant clinical considerations for prescribers, which may include, as appropriate and applicable, information related to the comparability of such biological products;

“(C) the process for reporting adverse events for biological products, including biosimilar biological products and interchangeable biosimilar biological products; and

“(D) the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under section 351(k) and reference products (as defined in section 351(i)), including the standards for review and licensing of each such type of biological product.

“(3) Format—The educational materials provided under paragraph (1) may be—

“(A) in formats such as webinars, continuing medical education modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats as appropriate and applicable; and

“(B) tailored for the unique needs of health care providers, patients, caregivers, and other audiences, as the Secretary determines appropriate.

“(4) Other information—In addition to the information described in paragraph (2), the internet website established under paragraph (1) shall include the following information, as a single, searchable database:

“(A) The action package of each biological product licensed under subsection (a) or (k), within 30 days of licensure, or, in the case of a biological product licensed before the date of enactment of the Lower Health Care Costs Act, not later than 1 year after such date of enactment.

“(B) The summary review of each biological product licensed under subsection (a) or (k), within 7 days of licensure, except where such materials require redaction by the Secretary, or, in the case of a biological product licensed before the date of enactment of the Lower Health Care Costs Act, not later than 1 year after such date of enactment.

“(5) Confidential and trade secret information—This subsection does not authorize the disclosure of any trade secret, confidential commercial or financial information, or other matter described in section 552(b) of title 5.

“(b) Continuing medical education—The Secretary shall advance education and awareness among health care providers regarding biological products, including biosimilar biological products and interchangeable biosimilar biological products, as appropriate, including by developing or improving continuing medical education programs that advance the education of such providers on the prescribing of, and relevant clinical considerations with respect to biological products, including biosimilar biological products and interchangeable biosimilar biological products.”

Sec. 207 Biological product innovation

Section 351(j) of the Public Health Service Act (42 U.S.C. 262(j)) is amended—
(1)
by striking “except that a product” and inserting “except that—

“(1) a product”

(2)
by striking “Act.” and inserting “Act; and”; and
(3)
by adding at the end the following:

“(2) no requirement under such Act regarding an official compendium (as defined in section 201(j) of such Act), or other reference in such Act to an official compendium (as so defined), shall apply with respect to a biological product subject to regulation under this section.”

Sec. 208 Clarifying the meaning of new chemical entity

Chapter V of the Federal Food, Drug, and Cosmetic Act is amended—
(1)
in section 505 (21 U.S.C. 355)—
(A)
in subsection (c)(3)(E)—
(i)
in clause (ii), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and
(ii)
in clause (iii), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;
(B)
in subsection (j)(5)(F)—
(i)
in clause (ii), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and
(ii)
in clause (iii), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;
(C)
in subsection (l)(2)(A)(i), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;
(D)
in subsection (s), in the matter preceding paragraph (1), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and
(E)
in subsection (u)(1), in the matter preceding subparagraph (A)—
(i)
by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and
(ii)
by striking “same active ingredient” and inserting “same active moiety”;
(2)
in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F))—
(A)
in clause (i), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;
(B)
in clause (ii), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and
(C)
in clause (v), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;
(3)
in section 524(a)(4)(C) (21 U.S.C. 360n(a)(4)(C)), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;
(4)
in section 529(a)(4)(A)(ii) (21 U.S.C. 360ff(a)(4)(A)(ii)), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”; and
(5)
in section 565A(a)(4)(D) (21 U.S.C. 360bbb–4a(a)(4)(D)), by striking “active ingredient (including any ester or salt of the active ingredient)” and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”.

Sec. 209 Streamlining the transition of biological products

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) is amended by adding at the end the following: “With respect to an application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) with a filing date that is not later than September 23, 2019, the Secretary shall continue to review and approve such application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), even if such review and approval process continues after March 23, 2020. Effective on the later of March 23, 2020, or the date of approval of such application under such section 505, such approved application shall be deemed to be a license for the biological product under section 351 of the Public Health Service Act.”.

Sec. 210 Orphan drug clarification

Section 527(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc(c)) is amended by adding at the end the following:

“(3) Applicability—This subsection applies to any drug designated under section 526 that was approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act after the date of enactment of the FDA Reauthorization Act of 2017, regardless of the date of on which such drug was designated under section 526.”

Sec. 211 Prompt approval of drugs related to safety information

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:

“(z) Prompt Approval of Drugs When safety information Is Added to Labeling

“(1) General rule—A drug for which an application has been submitted or approved under subsection (b)(2) or (j) shall not be considered ineligible for approval under this section or misbranded under section 502 on the basis that the labeling of the drug omits safety information, including contraindications, warnings, precautions, dosing, administration, or other information pertaining to safety, when the omitted safety information is protected by exclusivity under clause (iii) or (iv) of subsection (j)(5)(F), clause (iii) or (iv) of subsection (c)(3)(E), or section 527(a), or by an extension of such exclusivity under section 505A or 505E.

“(2) Labeling—Notwithstanding clauses (iii) and (iv) of subsection (j)(5)(F), clauses (iii) and (iv) of subsection (c)(3)(E), or section 527, the Secretary shall require that the labeling of a drug approved pursuant to an application submitted under subsection (b)(2) or (j) that omits safety information described in paragraph (1) include a statement of any appropriate safety information that the Secretary considers necessary to assure safe use.

“(3) Availability and scope of exclusivity—This subsection does not affect—

“(A) the availability or scope of exclusivity or an extension of exclusivity described in subparagraph (A) or (B) of section 505A(o)(3);

“(B) the question of the eligibility for approval under this section of any application described in subsection (b)(2) or (j) that omits any other aspect of labeling protected by exclusivity under—

“(i) clause (iii) or (iv) of subsection (j)(5)(F);

“(ii) clause (iii) or (iv) of subsection (c)(3)(E); or

“(iii) section 527(a); or

“(C) except as expressly provided in paragraphs (1) and (2), the operation of this section or section 527.”

Sec. 212 Conditions of use for biosimilar biological products

Section 351(k)(2)(A)(iii) of the Public Health Service Act (42 U.S.C. 262(k)(2)(A)(iii)) is amended—
(1)
in subclause (I), by striking “; and” and inserting a semicolon;
(2)
in subclause (II), by striking the period and inserting “; and”; and
(3)
by adding at the end the following:

“(III) may include information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product.”

Sec. 213 Modernizing the labeling of certain generic drugs

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503C the following:

“503D. Process to update labeling for certain drugs

“(a) Definitions—For purposes of this section:

“(1) The term covered drug means a drug approved under section 505(c)—

“(A) for which there are no unexpired patents included in the list under section 505(j)(7) and no unexpired period of market exclusivity;

“(B) for which the approval of the application has been withdrawn for reasons other than safety or effectiveness; and

“(C) for which, with respect to the labeling—

“(i) new scientific evidence is available regarding the conditions of use of the drug;

“(ii) there is a relevant accepted use in clinical practice that is not reflected in the approved labeling; or

“(iii) the labeling of such drug does not reflect current legal and regulatory requirements.

“(2) The term period of market exclusivity, with respect to a drug approved under section 505(c), means any period of market exclusivity under clause (ii), (iii), or (iv) of section 505(c)(3)(E), clause (ii), (iii), or (iv) of section 505(j)(5)(F), or section 505A, 505E, or 527.

“(3) The term generic version means a drug approved under section 505(j) whose reference drug is a covered drug.

“(4) The term relevant accepted use means a use for a drug in clinical practice that is supported by scientific evidence that appears to the Secretary to meet the standards for approval under section 505.

“(5) The term selected drug means a covered drug for which the Secretary has determined through the process under subsection (c) that the labeling should be changed.

“(b) Identification of covered drugs—The Secretary may identify covered drugs for which labeling updates would provide a public health benefit. To assist in identifying covered drugs, the Secretary may do one or both of the following:

“(1) Enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning such drugs.

“(2) Seek public input concerning such drugs, including input on whether there is a relevant accepted use in clinical practice that is not reflected in the approved labeling of such drugs or whether new scientific evidence is available regarding the conditions of use for such drug, by—

“(A) holding one or more public meetings;

“(B) opening a public docket for the submission of public comments; or

“(C) other means, as the Secretary determines appropriate.

“(c) Selection of drugs for updating—If the Secretary determines, with respect to a covered drug, that the available scientific evidence meets the standards under section 505 for adding or modifying information to the labeling or providing supplemental information to the labeling regarding the use of the covered drug, the Secretary may initiate the process under subsection (d).

“(d) Initiation of the process of updating—If the Secretary determines that labeling changes are appropriate for a selected drug pursuant to subsection (c), the Secretary shall provide notice to the holders of approved applications for a generic version of such drug that—

“(1) summarizes the findings supporting the determination of the Secretary that the available scientific evidence meets the standards under section 505 for adding or modifying information or providing supplemental information to the labeling of the covered drug pursuant to subsection (c);

“(2) provides a clear statement regarding the additional, modified, or supplemental information for such labeling, according to the determination by the Secretary (including, as applicable, modifications to add the relevant accepted use to the labeling of the drug as an additional indication for the drug); and

“(3) states whether the statement under paragraph (2) applies to the selected drug as a class of covered drugs or only as to a specific drug product.

“(e) Response to notification—Within 30 days of receipt of notification provided by the Secretary pursuant to subsection (d), the holder of an approved application for a generic version of the selected drug shall—

“(1) agree to change the approved labeling to reflect the additional, modified, or supplemental information the Secretary has determined to be appropriate; or

“(2) notify the Secretary that the holder of the approved application does not believe that the requested labeling changes are warranted and submit a statement detailing the reasons why such changes are not warranted.

“(f) Review of application holder's response

“(1) In general—Upon receipt of the application holder’s response, the Secretary shall promptly review each statement received under subsection (e)(2) and determine which labeling changes pursuant to the Secretary's notice under subsection (d) are appropriate, if any. If the Secretary disagrees with the reasons why such labeling changes are not warranted, the Secretary shall provide opportunity for discussions with the application holders to reach agreement on whether the labeling for the covered drug should be updated to reflect current scientific evidence, and if so, the content of such labeling changes.

“(2) Changes to labeling—After considering all responses from the holder of an approved application under paragraph (1) or (2) of subsection (e), and any discussion under paragraph (1), the Secretary may order such holder to make the labeling changes the Secretary determines are appropriate. Such holder of an approved application shall—

“(A) update its paper labeling for the drug at the next printing of that labeling;

“(B) update any electronic labeling for the drug within 30 days; and

“(C) submit the revised labeling through the form, “Supplement—Changes Being Effected”.

“(g) Violation—If the holder of an approved application for the generic version of the selected drug does not comply with the requirements of subsection (f)(2), such generic version of the selected drug shall be deemed to be misbranded under section 502.

“(h) Limitations; generic drugs

“(1) In general—With respect to any labeling change required under this section, the generic version shall be deemed to have the same conditions of use and the same labeling as a reference drug for purposes of clauses (i) and (v) of section 505(j)(2)(A). Any labeling change so required shall not have any legal effect for the applicant that is different than the legal effect that would have resulted if a supplemental application had been submitted and approved to conform the labeling of the generic version to a change in the labeling of the reference drug.

“(2) Supplemental applications—Changes to labeling made in accordance with this paragraph shall not be eligible for an exclusivity period under this Act.

“(i) Drug product classes—In the case of a selected drug for which the labeling changes ordered by the Secretary under subsection (d)(2) are required for a class of covered drugs, such labeling changes shall be made for generic versions of such drug in that class.

“(j) Rules of construction

“(1) Approval standards—This section shall not be construed as altering the applicability of the standards for approval of an application under section 505. No order shall be issued under this subsection unless the evidence supporting the changed labeling meets the standards for approval applicable to any change to labeling under section 505.

“(2) Removal of information—Nothing in this section shall be construed to give the Secretary additional authority to remove approved indications for drugs, other than the authority to remove certain indications from the labels of certain covered drugs, as described in this section.

“(k) Reports—Not later than 4 years after the date of the enactment of the Lower Health Care Costs Act and every 4 years thereafter, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report that—

“(1) describes the actions of the Secretary under this section, including—

“(A) the number of covered drugs and description of the types of drugs the Secretary has selected for labeling changes and the rationale for such recommended changes; and

“(B) the number of times the Secretary entered into discussions concerning a disagreement with an application holder or holders and a summary of the decision regarding a labeling change, if any; and

“(2) includes any recommendations of the Secretary for modifying the program under this section.”