Bill Sponsor
Senate Bill 1463
117th Congress(2021-2022)
Modernizing Therapeutic Equivalence Rating Determination Act
Introduced
Introduced
Introduced in Senate on Apr 29, 2021
Overview
Text
Introduced
Apr 29, 2021
Latest Action
Apr 29, 2021
Origin Chamber
Senate
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
1463
Congress
117
Policy Area
Health
Health
Primary focus of measure is science or practice of the diagnosis, treatment, and prevention of disease; health services administration and funding, including such programs as Medicare and Medicaid; health personnel and medical education; drug use and safety; health care coverage and insurance; health facilities. Measures concerning controlled substances and drug trafficking may fall under Crime and Law Enforcement policy area.
Sponsorship by Party
Republican
Louisiana
Democrat
Minnesota
Senate Votes (0)
House Votes (0)
No Senate votes have been held for this bill.
Summary

Modernizing Therapeutic Equivalence Rating Determination Act

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.

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.

(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.)


Text (1)
April 29, 2021
Actions (2)
04/29/2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
04/29/2021
Introduced in Senate
Public Record
Record Updated
Mar 8, 2023 8:26:14 PM