Bill Sponsor
House Bill 6258
116th Congress(2019-2020)
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020
Introduced
Introduced
Introduced in House on Mar 12, 2020
Overview
Text
Sponsor
Introduced
Mar 12, 2020
Latest Action
Mar 12, 2020
Origin Chamber
House
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
6258
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
House Votes (0)
Senate Votes (0)
No House votes have been held for this bill.
Summary

Reciprocity Ensures Streamlined Use of Lifesaving Treatments 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 and there is an unmet need.

Specifically, the bill requires the product's sponsor to demonstrate, among other things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.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 12, 2020
Actions (2)
03/12/2020
Referred to the House Committee on Energy and Commerce.
03/12/2020
Introduced in House
Public Record
Record Updated
Feb 8, 2022 11:17:30 PM