§356h — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary can speed up the review and development of a generic drug application if the drug is given a “competitive generic therapy” label at the applicant’s request. An applicant can ask for that label any time before or when they file their generic application. The Secretary has up to 60 calendar days to decide whether there is not enough generic competition and, if so, to give the label. If the label is given, the agency may hold meetings, give timely advice and interactive feedback, involve senior reviewers, and assign a cross-disciplinary project lead to help coordinate review steps (including inspections) and serve as a scientific contact. Within one year after approval, the drug sponsor must tell the Secretary whether the drug has been sold across state lines. Definitions: generic drug — a drug approved through the abbreviated generic pathway; inadequate generic competition — not more than one approved product on the official list for that drug (excluding discontinued products) that is either the brand-name listed drug or a generic using that same listed drug as its reference; reference listed drug — the listed brand product for the drug.

Title 21, §356h

Food and Drugs — Source: USLM XML via OLRC

(a)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 355(j) of this title for such drug.

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

(2)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 355(j) of this title.

(3)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)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)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 355(j) of this title.

(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)Not later than one year after the date of the approval of an application under section 355(j) of this title 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)In this section:

(1)The term “generic drug” means a drug that is approved pursuant to section 355(j) of this title.

(2)The term “inadequate generic competition” means, with respect to a drug, there is not more than one approved drugs 11 So in original. Probably should be “drug”. on the list of drugs described in section 355(j)(7)(A) of this title (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 355(j) of this title) for the drug involved.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Guidance; Amended

Regulations

Pub. L. 115–52, title VIII, § 803(b), Aug. 18, 2017, 131 Stat. 1071, provided that: “(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 [Aug. 18, 2017], issue draft guidance on section 506H of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356h], 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 [Aug. 18, 2017].”

§356h Competitive Generic Therapies

Summary

Title 21, §356h

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Regulations

Regulations

Regulations

Citations & Metadata