FDA Targets Five Actions for PREPP Initiative, Including Inspections and EUA Processes

The FDA has identified five main activities it will focus on for improving its COVID-19 Pandemic Recovery and Preparedness Plan (PREPP), including two on its reviews of  Emergency Use Authorization (EUA) processes and its approaches to inspections, public communications and supply-chain monitoring.

The PREPP initiative was launched in August 2020 to improve the FDA’s COVID-19 response but also prepare it for future public health crises.

Acting FDA Commissioner Janet Woodcock said that the agency intends to work on five main areas first identified in an independent third-party review of its PREPP initiative in January (DID, Jan. 19).

The agency intends to conduct a review of its EUA processes for COVID-19 medical products in order to pinpoint areas that can be made better, she said, noting that this combines two recommendations made by the independent reviewer.

“The objective is to ensure transparency and facilitate appropriate integration of these products including diagnostics, therapeutics and vaccines into medical care,” Woodcock said.

The report recommends that the agency bolster its EUA processes and tools through modernization and revamping, such as by further digitizing and standardizing its intake of EUA data, digitally upgrading workflow management and streamlining collaboration across its offices. It also suggested the agency further educate the public on its EUA pathway, such as by providing broader communication and selectively sharing scientific reviews.

The FDA will also assess the methods it’s employed for inspections during the pandemic in order to adapt to difficulties in conducting on-site activities. Woodcock said that the agency plans to evaluate its inspection approaches, including the use of virtual and video-enabled platforms, to increase its inspection capabilities.

The January report viewed the agency’s experiences during the pandemic as fuel for growing and optimizing its inspections operations even after the crisis is over. Enhancements could include the expansion and scaling of virtual tools, such as streaming technologies, the further utilization of risk-based assessments and accelerated efforts to increase collaboration with other regulators, among others, the report suggested.

In addition, Woodcock said the agency will evaluate its science-based communications to the public and perform an assessment of its current supply-chain tracking, monitoring and assessment systems to identify gaps and challenges.

Read the January report here: www.fdanews.com/01-18-21-FinalReport.pdf. — James Miessler