House Bill 6080
116th Congress(2019-2020)
Preventing Drug Shortages Act
Introduced
Introduced
Introduced in House on Mar 4, 2020
Overview
Text
Introduced
Mar 4, 2020
Latest Action
Mar 4, 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
6080
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
California
California
New York
North Carolina
Pennsylvania
No House votes have been held for this bill.
Summary

Preventing Drug Shortages Act

This bill expands existing manufacturer reporting requirements related to shortages of life-saving drugs and contains other related provisions.

The bill requires a manufacturer of an active pharmaceutical ingredient of a life-saving drug to notify the Food and Drug Administration (FDA) of an interruption that is likely to lead to a meaningful disruption in the ingredient's supply, whereas under current law this requirement generally applies only to the manufacturer of a life-saving drug that faces a supply disruption.

The notification must contain specified information, including any alternative sources for the ingredient.

The bill also requires a manufacturer of a life-saving drug or an active pharmaceutical ingredient for such a drug to include in its annual product registration the specific facilities where the drug or ingredient is manufactured. The FDA may also require the manufacturer to conduct periodic risk assessments to address vulnerabilities in its supply chain.

The Government Accountability Office shall report to Congress on the FDA's intra-agency coordination in assessing drug shortage risks.

Text (1)
March 4, 2020
Actions (2)
03/04/2020
Referred to the House Committee on Energy and Commerce.
03/04/2020
Introduced in House
Public Record
Created
Mar 5, 2020 8:12:15 AM
Updated
Jan 28, 2021 3:15:13 PM