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PREPP initiative: FDA’s COVID-19 response and the path forward

Posted 15 January 2021 | By Mary Ellen Schneider 

PREPP initiative: FDA’s COVID-19 response and the path forward

The US Food and Drug Administration (FDA) has adapted in its response to the COVID-19 pandemic, from increasing transparency of its risk-benefit analyses for emergency use authorizations (EUAs) to providing guidance on vaccine development, according to a summary report of the agency’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative.
The report catalogues the agency’s work during the pandemic, noting that it has published and revised more than 65 industry guidance documents related to COVID-19, reviewed more than 2,300 EUA requests and issued over 600 EUAs, and reviewed and conducted inspection activities related to nearly 400 therapeutic candidates.
The report, which was prepared by an external third party with input from FDA staff and stakeholder groups, also provides several recommendations for how to continue or expand the current regulatory flexibility beyond the public health emergency.
But the report’s recommendations are not a “to-do” list, FDA Commissioner Stephen M. Hahn, MD, and FDA deputy commissioner for medical and scientific affairs Anand Shah, MD, said in a statement.
“The agency will need to carefully consider the relevance and implementation feasibility associated with the ideas as it decides the appropriate courses of action in the continually evolving COVID-19 response and recovery,” they wrote.
Accelerating immediate response
The report outlines the steps the FDA took to immediately respond to the pandemic, including issuing guidance on developing drugs and biologics for treatment or prevention of COVID-19, a policy on diagnostic tests, and emergency use authorizations for vaccines. The agency also produced EUA templates for industry. The report notes that agency engaged in greater transparency around its decision making by publishing risk-benefit analyses related to several EUA decisions and live streaming advisory committee meetings.  
Going forward, the summary report includes some potential actions for the agency, including letting sponsors know how it plans to approach marketing applications for therapeutics and vaccines currently under development for COVID-19.
“The agency could communicate these plans to individual sponsors on a case-by-case or product class basis and/or through policy guidances,” according to the report. “Such communication could help sponsors plan for agency reviews, for example, and manufacturing scaleup of COVID-19 products.”
The report also calls for further digitizing and standardizing EUA data intake.
Scaling up innovation
The report identified several ways that the agency innovated its regulatory processes during 2020, such as taking a more iterative approach to creating guidance documents, releasing shorter and more focused guidance documents, and releasing Q&As. The agency also adapted its inspection protocols to allow for some remote records reviews and mutual recognition agreements with other regulatory bodies.
The PREPP summary report recommends that the agency build on guidance it issued in March 2020 on conducting clinical trials during COVID-19 to clarify how clinical trial guidance will change or continue after the pandemic. The report also calls on the agency to let developers know what other regulatory flexibilities will continue beyond the public health emergency.
“In the longer term, the agency could use the COVID-19 experience as a catalyst to define a broader agency-wide approach to encouraging sustained innovation in clinical trial conduct to drive efficiency and effectiveness in trial execution while improving patient experience and access,” the report states.
The report also called on FDA to incorporate the type of post-approval, real-world data collection that it has required during COVID-19 into the post-pandemic regulatory framework. “The feasibility of this action could depend, however, on broader adoption of the unique device identification system for medical devices sold in the US,” the report states.
Future pandemic preparedness
The agency has already begun to invest in preparing for future pandemics, according to the report. Specifically, the agency has expanded data access and analytical capabilities across its centers to more rigorously monitor supply chain risks related to drugs, foods, and medical devices. FDA has also been a part of the Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) consortia, which provides industry with guidance on clinical trial designs to speed the development of therapeutics and vaccines.
The report urges the agency to develop regulatory frameworks that encourage greater use of adaptive trials designs going forward. “FDA could undertake a review of potential regulatory barriers to broader adoption of master protocols and progress new guidance and industry engagement to address the identified barriers,” the report states. “FDA could also catalyze an industry-wide dialogue on data standards, analytical methods and clinical data exchange approaches (e.g., from electronic medical records) that facilitate consistent execution of pragmatic and adaptive designs.”
PREPP Initiative Report

Tags: coronavirus, FDA, US

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