Diagnostic Testing, Disease Preparedness Bills Introduced in Congress

Jun 11, 2023

NEW YORK –Two bipartisan bills introduced this week in Congress seek to better prepare the US for potential pandemics and other public health emergencies.

US Reps. Greg Pence (R-Indiana), Larry Bucshon (R-Indiana), Andre Carson (D-Indiana), and Kim Schrier (D-Washington) on Monday introduced a bill to help develop, scale, and distribute diagnostic tests during public health emergencies.

The bill is intended to facilitate the development of diagnostics for use with respect when there is a novel chemical, biological, radiological, or nuclear threat or an emerging infectious disease, according to the text of the Diagnostic Testing Preparedness Plan Act. It includes high-throughput laboratory tests, point-of-care tests, and rapid at-home or point-of-care tests.

The bipartisan bill would direct the US Secretary of Health and Human Services, through the Assistant Secretary for Preparedness and Response (ASPR), to work with other relevant agencies to develop a plan for the rapid development, approval, scaling, procurement, and distribution of diagnostics during a public health emergency. It would direct the ASPR to develop a plan for public and private sector coordination on national diagnostic testing and direct the HHS Secretary and the ASPR to make the plan publicly available within one year of enactment and updated every three years, Pence's office said in a statement. Private sector stakeholders include clinical and diagnostic laboratories, diagnostic manufacturers, healthcare product distributors, and research laboratories, according to the bill.

It would also direct the HHS Secretary and the ASPR to submit an after-action assessment and evaluation report to Congress within one year of the plan being activated.

"Diagnostics are essential for successful disease outbreak containment and response," Pence said in a statement. "It is important the HHS have a blueprint for communicating and collaborating with the private and public sectors to ensure diagnostics are readily available. In order to avoid issues during future public health emergencies, it is crucial for the HHS to be prepared with a plan for diagnostic testing in advance."

"One of the lessons learned from the pandemic is that we need to have a comprehensive plan in place that allows private sector innovators and the federal government to work together so that we can rapidly develop and distribute the diagnostic tools needed," Bucshon added.

Meanwhile, also on Monday, a bipartisan group of representatives introduced the Disease X Act of 2023 into the House of Representatives. The bill would establish a program at BARDA to "develop medical countermeasures for viral threats with pandemic potential," including the development of diagnostic tests, therapies, and vaccines.

Introduced by Reps. Lori Trahan (D-Massachusetts), Michael Burgess (R-Texas), Dan Crenshaw (R-Texas), and Susie Lee (D-Nevada) the bill would amend the Public Health Service Act to provide for "identification and development of platform manufacturing technologies" needed to develop and produce medical countermeasures for viruses and families of viruses with pandemic potential.