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# FDA Responsibilities in New Preparedness Bill
- URL: https://www.fdaweb.com/fda-responsibilities-in-new-preparedness-bill/
- Published: 2022-01-26T12:00:00.000Z
- Updated: 2026-09-14T17:30:08.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5151004

FDA would have many responsibilities in the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) released 1/25 by Sens. **Patty Murray** (D-WA) and **Richard Burr** (R-NC), the chair and ranking member of the Senate HELP Committee. Murray and Burr released a discussion [draft](https://www.help.senate.gov/chair/newsroom/press/murray-and-burr-release-discussion-draft-of-bipartisan-pandemic-and-public-health-preparedness-and-response-bill?ref=fdaweb.com) of the legislation that they say is “focused on strengthening the nation’s public health and medical preparedness and response systems in the wake of the Covid-19 pandemic.”

An [overview](https://www.help.senate.gov/imo/media/doc/PREVENT%20Pandemics%20discussion%20draft%20sxs%20final.pdf?ref=fdaweb.com) says the legislation would, among other provisions: 

- require FDA to issue three guidances to modernize and improve clinical trials;
- codify FDA’s successful Coronavirus Treatment Acceleration Program;
- clarify FDA authority to consult with third parties to evaluate and make recommendations on the validity, accuracy, and reliability of *in vitro* diagnostic tests for use during a public health emergency;
- require FDA to issue or revise guidance on using real-world data and real-world evidence to support regulatory decision-making;
- require FDA to issue guidance on the implementation of a new advanced platform technology designation;
- give FDA authority to share more safety and effectiveness information with the public about products authorized for emergency use;
- require FDA to publish a report on the agency’s best practices for communicating with medical product sponsors and other stakeholders and a plan for implementing the best practices;
- direct the Government Accountability Office to issue a report assessing FDA’s hiring, recruiting, and retention practices, policies, and processes and their impact on its ability to carry out its public health mission;
- require FDA to conduct a pilot program to increase the conduct of unannounced inspections of foreign drug facilities;
- strengthen FDA enforcement authority against and increase the penalties for selling counterfeit medical devices, including personal protective equipment; and
- authorize FDA to request from medical device manufacturers, in addition to drug manufacturers, certain records in advance of or in place of an inspection and require the agency to provide drug and device manufacturers with a rationale for its request for such records.

 Sens. Murray and Burr say they are continuing to work with their colleagues to develop additional provisions for the bill and hope to have committee mark-up in the coming weeks.