Senate Bill 3872
116th Congress(2019-2020)
Promising Pathway Act
Introduced
Introduced
Introduced in Senate on Jun 3, 2020
Overview
Text
Sponsor
Introduced
Jun 3, 2020
Latest Action
Jun 3, 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
3872
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
Indiana
Arkansas
Mississippi
North Dakota
No Senate votes have been held for this bill.
Summary

Promising Pathway Act

This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable.

The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations.

During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis.

The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties.

A provisionally approved drug must be labeled as such.

If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded.

The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective.

Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.

Text (1)
Actions (2)
06/03/2020
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
06/03/2020
Introduced in Senate
Public Record
Created
Jun 4, 2020 4:27:07 AM
Updated
Jan 4, 2021 1:04:37 PM