Bill Sponsor
Senate Bill 3545
116th Congress(2019-2020)
Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Co­ro­na­vi­rus Patients Act of 2020
Introduced
Introduced
Introduced in Senate on Mar 19, 2020
Overview
Text
Sponsor
Introduced
Mar 19, 2020
Latest Action
Mar 19, 2020
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
3545
Congress
116
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
Texas
Republican
Indiana
Senate Votes (0)
House Votes (0)
No Senate votes have been held for this bill.
Summary

Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020

This bill establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country for the treatment or prevention of COVID-19 (i.e., coronavirus disease 2019) and there is an unmet need relative to certain diseases.

Specifically, the bill requires the product's sponsor to demonstrate, among other things, that

  • the product has been approved for the treatment or prevention of COVID-19 or another disease of epidemic potential,
  • the approval is in one of the specified countries,
  • the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and
  • there is a public health or unmet medical need for the product.

The FDA may only decline approval if the FDA determines that the product is not safe or effective. The FDA must make such a determination not later than 30 days after receiving a request.

Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.

Text (1)
March 19, 2020
Actions (2)
03/19/2020
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
03/19/2020
Introduced in Senate
Public Record
Record Updated
Feb 8, 2022 11:23:05 PM