US Codex
Pub. L.
Notes

Title VIII — Improving Generic Drug Access

115th Congress · Approved Aug 18, 2017 · 131 Stat. 1005

TITLE VIII Improving Generic Drug Access

SEC. 801. Priority Review of Generic Drugs.

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

“(11)

(A) Subject to subparagraph (B), the Secretary shall prioritize the review of, and act within 8 months of the date of the submission of, an original abbreviated new drug application submitted for review under this subsection that is for a drug—

“(i) for which there are not more than 3 approved drug products listed under paragraph (7) and for which there are no blocking patents and exclusivities; or

“(ii) that has been included on the list under section 506E.

“(B) To qualify for priority review under this paragraph, not later than 60 days prior to the submission of an application described in subparagraph (A) or that the Secretary may prioritize pursuant to subparagraph (D), the applicant shall provide complete, accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application, including facilities in corresponding Type II active pharmaceutical ingredients drug master files referenced in an application and sites or organizations involved in bioequivalence and clinical studies used to support the application, to enable the Secretary to make a determination regarding whether an inspection of a facility is necessary. Such information shall include the relevant (as determined by the Secretary) sections of such application, which shall be unchanged relative to the date of the submission of such application, except to the extent that a change is made to such information to exclude a facility that was not used to generate data to meet any application requirements for such submission and that is not the only facility intended to conduct one or more unit operations in commercial production. Information provided by an applicant under this subparagraph shall not be considered the submission of an application under this subsection.

“(C) The Secretary may expedite an inspection or reinspection under section 704 of an establishment that proposes to manufacture a drug described in subparagraph (A).

“(D) Nothing in this paragraph shall prevent the Secretary from prioritizing the review of other applications as the Secretary determines appropriate.

“(12) The Secretary shall publish on the internet website of the Food and Drug Administration, and update at least once every 6 months, a list of all drugs approved under subsection (c) for which all patents and periods of exclusivity under this Act have expired and for which no application has been approved under this subsection.”

SEC. 802. Enhancing Regulatory Transparency to Enhance Generic Competition.

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 801, is further amended by adding at the end the following:

“(13) Upon the request of an applicant regarding one or more specified pending applications under this subsection, the Secretary shall, as appropriate, provide review status updates indicating the categorical status of the applications by each relevant review discipline.”

SEC. 803. Competitive Generic Therapies.

(a)
In General.— Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506G the following:

“SEC. 506H. COMPETITIVE GENERIC THERAPIES.

“(a) In General.—The Secretary may, at the request of an applicant of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of an abbreviated new drug application under section 505(j) for such drug.

“(b) Designation Process.—

“(1) Request.—The applicant may request the Secretary to designate the drug as a competitive generic therapy.

“(2) Timing.—A request under paragraph (1) may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under section 505(j).

“(3) Criteria.—A drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition.

“(4) Designation.—Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may—

“(A) determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and

“(B) if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy.

“(c) Actions.—In expediting the development and review of an application under subsection (a), the Secretary may, as requested by the applicant, take actions including the following:

“(1) Hold meetings with the applicant and the review team throughout the development of the drug prior to submission of the application for such drug under section 505(j).

“(2) Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable.

“(3) Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to drug-device combination products and other complex products.

“(4) Assign a cross-disciplinary project lead—

“(A) to facilitate an efficient review of the development program and application, including manufacturing inspections; and

“(B) to serve as a scientific liaison between the review team and the applicant.

“(d) Reporting Requirement.—Not later than one year after the date of the approval of an application under section 505(j) with respect to a drug for which the development and review is expedited under this section, the sponsor of such drug shall report to the Secretary on whether the drug has been marketed in interstate commerce since the date of such approval.

“(e) Definitions.—In this section:

“(1) The term ‘generic drug’ means a drug that is approved pursuant to section 505(j).

“(2) The term ‘inadequate generic competition’ means, with respect to a drug, there is not more than one approved drugs on the list of drugs described in section 505(j)(7)(A) (not including drugs on the discontinued section of such list) that is—

“(A) the reference listed drug; or

“(B) a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.

“(3) The term ‘reference listed drug’ means the listed drug (as such term is used in section 505(j)) for the drug involved.”

(b)
Guidance; Amended Regulations.—
(1)
In general.—
(A)
Issuance.— The Secretary of Health and Human Services shall—
(i)
not later than 18 months after the date of enactment of this Act, issue draft guidance on section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); and
(ii)
not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such section 506H.
(B)
Contents.— The guidance issued under this paragraph shall—
(i)
specify the process and criteria by which the Secretary makes a designation under section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);
(ii)
specify the actions the Secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and
(iii)
include good review management practices for competitive generic therapies.
(2)
Amended regulations.— The Secretary of Health and Human Services shall issue or revise any regulations as may be necessary to carry out this section not later than 2 years after the date of enactment of this Act.

SEC. 804. Accurate Information About Drugs with Limited Competition.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506H, as added by section 803, the following:

“SEC. 506I. PROMPT REPORTS OF MARKETING STATUS.

“(a) Notification of Withdrawal.—The holder of an application approved under subsection (c) or (j) of section 505 shall notify the Secretary in writing 180 days prior to withdrawing the approved drug from sale, or if 180 days is not practicable as soon as practicable but not later than the date of withdrawal. The holder shall include with such notice the—

“(1) National Drug Code;

“(2) identity of the drug by established name and by proprietary name, if any;

“(3) new drug application number or abbreviated application number;

“(4) strength of the drug;

“(5) date on which the drug is expected to no longer be available for sale; and

“(6) reason for withdrawal of the drug.

“(b) Notification of Drug Not Available for Sale.—The holder of an application approved under subsection (c) or (j) shall notify the Secretary in writing within 180 calendar days of the date of approval of the drug if the drug will not be available for sale within 180 calendar days of such date of approval. The holder shall include with such notice the—

“(1) identity of the drug by established name and by proprietary name, if any;

“(2) new drug application number or abbreviated application number;

“(3) strength of the drug;

“(4) date on which the drug will be available for sale, if known; and

“(5) reason for not marketing the drug after approval.

“(c) Additional One-time Report.—Within 180 days of the date of enactment of this section, all holders of applications approved under subsection (c) or (j) of section 505 shall review the information in the list published under subsection 505(j)(7)(A) and shall notify the Secretary in writing that—

“(1) all of the application holder’s drugs in the active section of the list published under subsection 505(j)(7)(A) are available for sale; or

“(2) one or more of the application holder’s drugs in the active section of the list published under subsection 505(j)(7)(A) have been withdrawn from sale or have never been available for sale, and include with such notice the information required pursuant to subsection (a) or (b), as applicable.

“(d) Failure to Meet Requirements.—If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may move the application holder’s drugs from the active section of the list published under subsection 505(j)(7)(A) to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with subsection 505(j)(7)(C) drugs the Secretary determines have been withdrawn from sale for reasons of safety of effectiveness.

“(e) Updates.—The Secretary shall update the list published under subsection 505(j)(7)(A) based on the information provided under subsections (a), (b), and (c) by moving drugs that are not available for sale from the active section to the discontinued section of the list, except that drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness shall be removed from the list in accordance with subsection 505(j)(7)(C). The Secretary shall make monthly updates to the list based on the information provided pursuant to subsections (a) and (b), and shall update the list based on the information provided under subsection (c) as soon as practicable.

“(f) Limitation on Use of Notices.—Any notice submitted under this section shall not be made public by the Secretary and shall be used solely for the purpose of the updates described in subsection (e).”

SEC. 805. Suitability Petitions.

(a)
In General.— It is the sense of Congress that the Food and Drug Administration shall meet the requirement under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(C)) and section 314.93(e) of title 21, Code of Federal Regulations, of responding to suitability petitions within 90 days of submission.
(b)
Report.— The Secretary of Health and Human Services shall include in the annual reports under section 807—
(1)
the number of pending petitions under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(C)); and
(2)
the number of such petitions pending a substantive response for more than 180 days from the date of receipt.

SEC. 806. Inspections.

Within 6 months of the date of enactment of this Act, the Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374). Such protocol shall—
(1)
apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)—
(A)
for which the approval is dependent upon remediation of conditions identified in the report;
(B)
for which concerns related to observations from an inspection under such section 704 are the only barrier to approval; and
(C)
where the drug that is the subject of the application is a drug—
(i)
for which there are not more than 3 other approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that reference the same listed drug and for which there are less than 6 abbreviated new drug applications tentatively approved; or
(ii)
that is included on the list under section 506E of such Act (21 U.S.C. 356e);
(2)
address expedited re-inspection of facilities, as appropriate; and
(3)
establish a 6-month timeline for completion of review of such responses to such reports.

SEC. 807. Reporting on Pending Generic Drug Applications and Priority Review Applications.

Not later than 180 calendar days after the date of enactment of this Act, and quarterly thereafter until October 1, 2022, the Secretary of Health and Human Services shall post on the internet website of the Food and Drug Administration a report that provides, with respect to the months covered by the report—
(1)
with respect to applications filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that, during the most recent calendar year, were subject to priority review under paragraph (11) of such section 505(j) (as added by section 801) or expedited development and review under section 506H of the Federal Food, Drug, and Cosmetic Act (as added by section 803), the numbers of such applications (with denotation of such applications that were filed prior to October 1, 2014) that are—
(A)
awaiting action by the applicant;
(B)
awaiting action by the Secretary; and
(C)
approved by the Secretary;
(2)
the number of applications filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) and prior approval supplements withdrawn in each month;
(3)
the mean and median approval and tentative approval times and the number of review cycles for such applications;
(4)
the number and type of meetings requested and held under such section 506H (as added by section 803); and
(5)
the number of such applications on which the Secretary has taken action pursuant to subsection (c) of such section 506H (as added by section 803) and any effect such section 506H may have on the length of time for approval of applications under such section 505(j) and the number of review cycles for such approvals.

SEC. 808. Incentivizing Competitive Generic Drug Development.

Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is amended—
(1)
in subparagraph (B), by adding at the end the following:

“(v) 180-day exclusivity period for competitive generic therapies.—

“(I) Effectiveness of application.—Subject to subparagraph (D)(iv), if the application is for a drug that is the same as a competitive generic therapy for which any first approved applicant has commenced commercial marketing, the application shall be made effective on the date that is 180 days after the date of the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant.

“(II) Limitation.—The exclusivity period under subclause (I) shall not apply with respect to a competitive generic therapy that has previously received an exclusivity period under subclause (I).

“(III) Definitions.—In this clause and subparagraph (D)(iv):

“(aa) The term ‘competitive generic therapy’ means a drug—

“(AA) that is designated as a competitive generic therapy under section 506H; and

“(BB) for which there are no unexpired patents or exclusivities on the list of products described in section 505(j)(7)(A) at the time of submission.

“(bb) The term ‘first approved applicant’ means any applicant that has submitted an application that—

“(AA) is for a competitive generic therapy that is approved on the first day on which any application for such competitive generic therapy is approved;

“(BB) is not eligible for a 180-day exclusivity period under clause (iv) for the drug that is the subject of the application for the competitive generic therapy; and

“(CC) is not for a drug for which all drug versions have forfeited eligibility for a 180-day exclusivity period under clause (iv) pursuant to subparagraph (D).”

; and

(2)
in subparagraph (D), by adding at the end the following:

“(iv) Special forfeiture rule for competitive generic therapy.—The 180-day exclusivity period described in subparagraph (B)(v) shall be forfeited by a first approved applicant if the applicant fails to market the competitive generic therapy within 75 days after the date on which the approval of the first approved applicant’s application for the competitive generic therapy is made effective.”

SEC. 809. Gao Study of Issues Regarding First Cycle Approvals of Generic Medicines.

(a)
Study by GAO.— The Comptroller General of the United States shall conduct a study to determine the following:
(1)
The rate of first cycle approvals and tentative approvals for applications submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) during the period beginning on October 1, 2012, and ending on September 30, 2017. The rate of first cycle approvals and tentative approvals shall be determined and reported per each GDUFA cohort year during this period.
(2)
If the rate determined pursuant to paragraph (1) for any GDUFA cohort year is lower than 20 percent, the reasons contributing to the relatively low rate of first cycle approvals and tentative approvals for generic drug applications shall be itemized, assessed, and reported. In making the assessment required by this paragraph, the Comptroller General shall consider, among other things, the role played by—
(A)
the Food and Drug Administration’s implementation of approval standards for generic drug applications;
(B)
the extent to which those approval standards are communicated clearly to industry and applied consistently during the review process;
(C)
the procedures for reviewing generic drug applications, including timelines for review activities by the Food and Drug Administration;
(D)
the extent to which those procedures are followed consistently (and those timelines are met) by the Food and Drug Administration;
(E)
the processes and practices for communication between the Food and Drug Administration and sponsors of generic drug applications; and
(F)
the completeness and quality of original generic drug applications submitted to the Food and Drug Administration.
(3)
Taking into account the determinations made pursuant to paragraphs (1) and (2) and any review process improvements implemented pursuant to this Act, whether there are ways the review process for generic drugs could be improved to increase the rate of first cycle approvals and tentative approvals for generic drug applications. In making this determination, the Comptroller General shall consider, among other things, options for increasing review efficiency and communication effectiveness.
(b)
Completion Date.— Not later than the expiration of the 2-year period beginning on the date of enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit a report describing the findings and conclusions of the study to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate.
(c)
Definitions.— For purposes of this section:
(1)
The term “GDUFA cohort year” means a fiscal year.
(2)
The term “generic drug” means a drug that is approved or is seeking approval under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
(3)
The term “generic drug application” means an abbreviated new drug application for the approval of a generic drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
(4)
The term “Secretary” means the Secretary of Health and Human Services.
(5)
(A)
The term “first cycle approvals and tentative approvals” means the approval or tentative approval of a generic drug application after the Food and Drug Administration’s complete review of the application and without issuance of one or more complete response letters.
(B)
For purposes of this paragraph, the term “complete response letter” means a written communication to the sponsor of a generic drug application or holder of a drug master file from the Food and Drug Administration describing all of the deficiencies that the Administration has identified in the generic drug application (including pending amendments) or drug master file that must be satisfactorily addressed before the generic drug application can be approved.