Increased use of virtual tools, optimized inspectional activities, & enhanced supply chain oversight

The future of inspections under FDA’s COVID-19 PREPP initiative

The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due to the pandemic, FDA has been forced to pilot new inspectional initiatives, including increased use of records requests under 21 USC 374(a)(4) and increased reliance other health authorities’ inspections under the Mutual Reliance Initiative (MRI).

On January 13, FDA published a summary report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative, which was launched internally in April 2020 and announced publicly in August 2020. According to the summary report, the PREPP initiative is aimed at strengthening FDA’s ongoing COVID-19 response and building the agency’s resilience to respond to future emergencies, including by identifying several “broad cross-cutting ‘Action Areas’ that reflect ongoing and potential prospective actions.” Notably, these action areas include “continu[ing] to evolve and optimize inspectional operations, building on the COVID-19 experience as a catalyst” and “strengthen[ing] supply chain surveillance for regulated products,” suggesting that several of FDA’s COVID-related inspection pilot projects will continue into the future.

Virtual inspection tools and optimizing inspection activities

The summary report identifies “continu[ing] to evolve and optimize inspectional operations, building on the COVID-19 experience as a catalyst for improvements” as a priority recommendation. In addition to the actions already taken, including increased use of records requests under 21 USC 347(a)(4) and increased reliance on other health authorities’ inspections under MRI, the report recommends that FDA “build on its experiences using diversified inspectional approaches in the pandemic to shape and pursue a longer-term, more thorough “optimization” of inspectional operations.” This could include:

  • expanding and scaling, as appropriate, the use of virtual tools such as read-only access to sponsor databases for the Bioresearch Monitoring program;

  • using supportive technologies such as increased bandwidth and/or streaming capabilities for facility assessment;

  • taking a more consistent and dynamic approach to assessing risk-based resource allocation to inspectional activities;

  • transitioning to more continuous, stakeholder-centric engagement with regulated industry; and

  • accelerating efforts to cultivate a convergence of approaches with other competent authorities around the world.

The purposes of such a “comprehensive” optimization roadmap could include increasing the effectiveness of inspectional operations and using the program’s resources more efficiently.

The report also recommends that FDA consider establishing virtual meetings to facilitate transfer of records before onsite inspections, which would allow FDA to “deploy FDA resources to sites with the greatest needs” and also allow investigators to focus on specific, pre-identified issues during on-site inspections.

Supply chain oversight

The summary report also identifies increased supply chain surveillance as an action area. The report cites CDER’s cross-functional Supply Chain Surveillance Task Force as an example of how the various offices across FDA can work together to implement an integrative supply chain surveillance data analytics platform to mitigate and address specific drug shortages. Accordingly, the report recommends that FDA consider “enhancing its supply chain surveillance capabilities, including those related to data and analytics.”

The report further recommends that FDA encourage the use of process technology innovations to mitigate supply chain risks. This could include, for example, “continuous manufacturing and improved automation, digital technologies and advanced analytics such as machine learning, digital twin, and AI for operations management and delivering quality controls, assurance and compliance.” Notably, the report specifically recommends that FDA consider promulgating guidance on the use of “artificial intelligence and machine learning in the Good Manufacturing Practice (GMP) environment.”

Our thoughts

The PREPP summary report suggests that FDA does not plan to return to business as usual at the end of the pandemic, at least from an inspectional perspective. Rather, we expect FDA to use its records request authority and newly piloted virtual inspection tools in addition to the agency’s traditional on-site activities to allow for more targeted on-site inspections. For example, in some circumstances FDA investigators will not need to spend days in facility conference rooms combing through documents; rather, this will be done remotely and in advance of the inspection, allowing the investigators to focus on specific issues during on-site inspections.

In addition, FDA’s focus on the pharmaceutical supply chain will likely mean enhanced scrutiny for manufacturers of critical medicines and manufacturers that are the sole source of product. This will likely mean more inspections (on-site and virtual) and more records requests for manufacturing sites critical to supply chain continuity—particularly those manufacturing sites critical to the supply chain that are located outside the United States. We believe that FDA will also continue to encourage the adoption of advanced manufacturing technologies, including continuous manufacturing and AI, as a way to strengthen the pharmaceutical supply chain.

 

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