FDA Postpones US Inspections, Issues Clinical Trials Guidance Due to COVID-19By
The US Food and Drug Administration (FDA) has announced that it has temporarily postponed all domestic routine surveillance facility inspections due to the novel coronavirus (COVID-19) outbreak and has issued guidance for conducting clinical trials that may face disruptions in light of COVID-19.
FDA postpones domestic surveillance inspections
In temporarily postponing all domestic routine surveillance facility inspections, the agency did not specify when these inspections would resume. The agency said that domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.
Earlier this month (March 10, 2020), the agency announced that it was postponing most inspections of foreign facilities through April 2020 in response to the COVID-19 outbreak. Inspections outside the US deemed mission-critical will still be considered on a case-by-case basis, said the FDA at the time of its March 10, 2020 statement.
Domestic surveillance facility projects are facility inspections the FDA traditionally conducts every few years based on a risk analysis. The agency said that all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical and that it will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products.
The agency also updated other staff activities due to the COVID-19 outbreak. “In keeping with the White House Coronavirus Task Force and cross-government guidance, this week [week of March 16, 2020), we directed all eligible FDA employees to begin teleworking,” said FDA Commissioner Stephen M. Hahn, in a March 18, 2020 statement. “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.”
Hahn said that during this interim period, the agency is evaluating additional ways to conduct its 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.
“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,” said Hahn in the agency’s statement. “In fact, in last fiscal year, the overall domestic violation rate was only about 5%.”
FDA issues guidance on clinical trials in wake of COVID-19
The FDA also has issued final guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.
“With this guidance issued today, the FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials,” said Anand Shah, FDA Deputy Commissioner for Medical and Scientific Affairs, in a March 18, 2020 statement. “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity while also safeguarding the health and well-being of study participants.”
The FDA outlined that in wake of COVID-19 certain challenges may arise in conducting clinical trials, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19.
The FDA acknowledged that these challenges may lead to difficulties in conducting the clinical trials and that it is aware that protocol modifications may be required and that there may be unavoidable protocol deviations due to COVID-19.
“Although the impact of COVID-19 on trials will vary depending on many factors, including the nature of disease under study, the trial design and in what region(s) the study is being conducted, the FDA outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity,” said the FDA in the March 18 statement.
Considerations recommended by the FDA include, among others, sponsors evaluating alternative methods for assessments, such as phone contacts or virtual visits and offering additional safety monitoring for those trial participants who may no longer have access to investigational product or the investigational site.