117 S1462 IS: Simplifying the Generic Drug Application Process Act U.S. Senate 2021-04-29 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II117th CONGRESS1st SessionS. 1462IN THE SENATE OF THE UNITED STATESApril 29, 2021Mr. Cassidy (for himself and Ms. Smith) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo amend the Federal Food, Drug, and Cosmetic Act to simplify the generic drug application process.

1.

Short title

This Act may be cited as the Simplifying the Generic Drug Application Process Act.

2.

Submission for suitability

Subparagraph (C) of section 505(j)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)) is amended to read as follows:(C)

Submission for suitability determinations

(i)

In general

A person may submit an abbreviated application for a new drug that has a different dosage form or strength from that of a listed drug.(ii)

Secretary's determination on submission

The Secretary shall approve or disapprove the submission of such an abbreviated application during the course of its determination whether to receive the application pursuant to section 314.101 of title 21, Code of Federal Regulations (or any successor regulations).(iii)

Approval of submission

The Secretary shall approve the submission of such an abbreviated application, provided the application is otherwise determined to be eligible to be received, unless the Secretary finds that—(I)clinical investigations are required to be conducted to show the safety and effectiveness of the drug or of any of its dosage forms or strengths which differ from the listed drug; or(II)any of the proposed changes from the listed drug would jeopardize the safe or effective use of the product so as to necessitate significant labeling changes to address the newly introduced safety or effectiveness problem.(iv)

Disapproval of submission

If the Secretary disapproves the submission of an abbreviated application under this subparagraph, the application shall be considered not to have been received within the meaning of paragraph (5)(A)..