Competitive generic therapies
In general
Designation process
Request
Timing
Criteria
Designation
Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may—
determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and
if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy.
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:
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.
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.
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.
Assign a cross-disciplinary project lead—
to facilitate an efficient review of the development program and application, including manufacturing inspections; and
to serve as a scientific liaison between the review team and the applicant.
Reporting requirement
Definitions
In this section:
The term “generic drug” means a drug that is approved pursuant to section 355(j) of this title.
The term “inadequate generic competition” means, with respect to a drug, there is not more than one approved drugs 1
the reference listed drug; or
a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.
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.
Source
(June 25, 1938, ch. 675, § 506H, as added Pub. L. 115–52, title VIII, § 803(a),Notes
Statutory Notes and Related Subsidiaries
Guidance; Amended Regulations
In general.—
Issuance.—
The Secretary of Health and Human Services shall—
not later than 18 months after the date of enactment of this Act [
not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such section 506H.
Contents.—
The guidance issued under this paragraph shall—
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);
specify the actions the Secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and
include good review management practices for competitive generic therapies.
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 [