An Overview of FDA’s Roadmap for Inspectional Oversight as the Pandemic Continues

The global Covid-19 pandemic compelled the United States to lock down and implement social distancing. Putting the safety of its own employees first and meeting federal guidelines to mitigate the spread of the COVID-19 virus, the U.S. Food and Drug Administration (US FDA) only conducted mission-critical inspections and paused all other domestic and foreign inspections. For routine surveillance inspectional activities, it implemented several innovative approaches by leveraging available digital tools.

Multiple Approaches to Inspections

Knowing the critical nature of its function, the FDA adopted several approaches for inspections during the pandemic. It conducted remote inspections and published a guidance document on how to run remote interactive evaluations using live-streaming of drug manufacturing facilities. It also developed a COVID-19 Advisory Rating system (COVID-19 Advisory Level) to qualitatively assess the virus risk at the county level and identify sites where it was safe to conduct an inspection.

The FDA also utilized section 704(a)(4) that assigns FDA the authority to request records and other information from domestic and foreign establishments for:

• Making decisions on application approval
• Identifying areas that need inspections in the future
• Identifying violations and place the products on import alert

By accessing compliance history reviews of facilities, recalls and product complaints, it was able to prioritize oversight activities.

It leveraged the information shared by trusted regulatory partners at the state, local, tribal, and territorial levels. Under the Mutual Recognition Agreement (MRA), it was able to leverage information provided by trusted foreign regulatory partners.

Risk-based product sampling and analytical testing of FDA-regulated products domestically and at international borders also helped with confirming compliance.

Despite these efforts, the FDA has been unable to complete inspecting all the facilities for which it received applications. Of the nearly 21,000 establishments it regulates across all commodities including human and animal drugs, medical devices, radiological health facilities, biologics, biological research monitoring, and tobacco, it was able to complete only 13,000.

Now the agency says it plans to conduct a total of 26,250 surveillance inspections in FY21, including any remaining surveillance inspections postponed from the previous fiscal year. As of March 2021, the agency had inspected 2,953 of these facilities.

It has released a "Resiliency Roadmap for FDA Inspectional Oversight" for providing transparency into its plans for the future while giving an overview of the past year. This roadmap lists out its plans for base/best/worst-case scenarios as the pandemic continues to spread around the globe.

The FDA will be using a risk-based approach to speed up the inspection work without compromising the safety of its workforce.

The best-case scenario envisages resuming normal inspection operations. In the base-case or average scenario, it will resume normal operations after mid-summer. In the worst-case scenario, it will continue with its restrictive pandemic operations.

Types of Inspections

There are three types of inspections that the FDA conducts:

For-cause Inspections: conducted when there is a serious manufacturing problem or in case of a specific problem or product complaint that has been brought to FDA’s notice

Pre-approval, Pre-market or Pre-license Inspections: when an application to market a new product is submitted, the inspection conducted as part of the review when necessary

Surveillance: routine inspections of regulated facilities to monitor ongoing compliance with requirements such as Current Good Manufacturing Practice (CGMP)

But because of the pandemic, it restricted itself to mission-critical inspections that are prioritized and include:

• A product designated as breakthrough therapy or regenerative medicine advanced therapy
• A product without a substitute to treat a serious disease or medical condition
• A product that has been recalled or causes serious adverse events or outbreaks of a foodborne illness and needs follow-up action
• When a product is related to FDA’s COVID-19 response (e.g., drug shortages)

The FDA conducted 822 mission-critical inspections in 2020-21.

Looking Forward

The past year and the pandemic have provided the FDA with an opportunity to consider more efficient regulatory approaches to fulfill its public health mission of ensuring product quality. To this end, it plans to advance regulatory convergence and explore collaborative approaches with trusted partners as well as foster alignment around modernizing policies and practices for improving its outcomes.

It plans to expand its workforce to meet its goals better and step-up modernization efforts to transform its data enterprise platforms and cross-program interoperability infrastructure for enabling innovative approaches to regulatory oversight.

Some of the key modernization efforts will include investing in next-generation assessment technologies and improvements while reviewing available authorities for potential legislative proposals.

To speed up evaluation and potential integration of new oversight methods and tools, the FDA will also work on improving coordination for inspections, information sharing, and other processes. As a result of consistent use of tools and technologies, it expects to increase flexibility and further encourage a data-driven, risk-based oversight modeling across the agency as well as the nation’s public health system.

Mission-critical and prioritized inspections will continue to be the focus areas for FDA throughout the pandemic and routine surveillance of facilities with less risk will be a lower priority, but additional tools will be deployed to continue the protection of public health through regulatory oversight.

Through this roadmap, FDA has reiterated its commitment to public health and patient safety.

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