Thursday, April 9, 2020

Thursday, April 9, 2020

FDA: Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections


U.S. Food and Drug Administration issued the following announcement on March 18.

Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration. As a nation we must do everything we can to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic. Now more than ever, the American people are depending on us. We must ensure our workforce remains healthy to carry out the FDA’s critical public health mission to keep Americans safe.

In keeping with the White House Coronavirus Task Force and cross-government guidance, this week we directed all eligible FDA employees to begin teleworking. While this does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products, we will continue to adjust our approach to a number of activities, including facility inspections for all FDA-regulated products such as food, animal feed, drugs, biological products, devices and tobacco.

Earlier this month, we announced that we are postponing most foreign facility inspections through April and that inspections outside the U.S. deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold.

Today, we’re announcing that for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products.

I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate.

Importantly, during this interim period we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protecting both the firms and the FDA staff. This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate.

In fact, inspections are just one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA-regulated products, however inspections are not what cause quality to happen. Safety and quality need to be owned by the industry and firms have the primary responsibility to reliably produce quality products. For example, the medical product and food industries we regulate are subject to certain reporting requirements about their facilities and also must adhere to Current Good Manufacturing Practice (cGMP) requirements pertaining to, for example, operating procedures, manufacturing, sanitation, and processing controls, as well as preventive controls to reduce or eliminate food safety hazards.

From our experience across the agency, we also believe FDA-regulated firms understand and appreciate their shared responsibility to ensure the integrity of the supply chain and we will continue to communicate with them during this time to underscore this partnership. In fact, in last fiscal year, the overall domestic violation rate was only about 5%.

The FDA remains committed to using all available tools to oversee the safety and quality of FDA-regulated products for American patients and consumers. As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed and we stand ready to resume any postponed inspections as soon as feasible.

Original source can be found here.

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U.S. Food and Drug Administration

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