Modernizing Therapeutic Equivalence Rating Determination Act

Bill: 117-s-1463
Sponsor: full_name: Sen. Cassidy, Bill [R-LA]
Introduced: 2021-04-29
Policy area: Health
Subjects: Administrative remedies

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Government information and archives

Prescription drugs
Latest action: action_date: 2021-04-29
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2021-04-29
action_desc: Introduced in Senate
text: <p><strong>Modernizing Therapeutic Equivalence Rating Determination Act</strong></p> <p>This bill requires the Food and Drug Administration (FDA) to provide a therapeutic equivalence rating for certain new drug applications if the applicant requests such a rating. </p> <p>Upon request in the application, the FDA must provide such a rating for a new drug application that relies on information from studies not conducted by the applicant and that the applicant does not have a right to reference or use (commonly referred to as a 505(b)(2) application). The FDA must provide the rating no later than 30 days after the application's approval. </p> <p>(A drug is a therapeutic equivalent of another if they produce the same clinical effect and have the same safety profile. Typically, for certain generic drugs, the FDA rates the therapeutic equivalence of that generic drug to another drug, such as the brand name version. Currently, an applicant seeking approval of a drug through a 505(b)(2) application typically only receives an equivalence rating by requesting one from the FDA in a separate petition.)</p> <p><br> </p>

tv_txt: II 117th CONGRESS 1st Session S. 1463 IN THE SENATE OF THE UNITED STATES April 29, 2021 Mr. Cassidy (for himself and Ms. Smith ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act to modernize therapeutic equivalence rating determinations.

1. Short title This Act may be cited as the Modernizing Therapeutic Equivalence Rating Determination Act . 2. Therapeutic equivalence determinations Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7)(A) ) is amended by adding at the end the following: (v) (I) The Secretary shall make a determination under clause (i)(III)— (aa) with respect to an application submitted under this subsection, at the time of approval of such application or not later than 30 days after the date of such approval; or (bb) with respect to an application submitted under subsection (b)(2), at the time of approval of such application or not later than 30 days after the date of such approval, provided that the sponsor requests such a determination in the original application, in a form prescribed by the Secretary. (II) When the Secretary makes a determination under clause (i)(III), the Secretary shall, in revisions made to the list pursuant to clause (ii), include such information for such drug. (III) When the Secretary makes a determination under clause (i)(III) with respect to a drug, the Secretary shall, at the same time, make such a determination with respect to any other drug— (aa) whose application under subsection (b)(2) was approved; (bb) which references the same listed drug as the application for the first drug for which such determination is made; and (cc) for which there is a citizen petition pending requesting that the Secretary make a determination under clause (i)(III). .