SummaryIn response to the COVID-19 pandemic, FDA has announced actions that may have much broader implications for drug development, lifecycle management, and oversight.
Specifically, the FDA suspended foreign and domestic routine surveillance facility inspections and released guidance on how to proceed with current clinical trials, including updates to enrollment and oversight, on new medical products during the pandemic. It is possible that actions taken during this time will have lasting consequences on drug development, such as acceptable clinical trial design, inspections timelines, and broader opportunities for using real-world evidence. With user fee discussions on the horizon, it is likely that these topics will enter the debate as lessons are learned by the industry and the FDA.
Postponing Routine Inspections
The FDA is now allowing eligible members of its workforce to telework in an effort to comply with federally recommended social-distancing efforts in response to the COVID-19 pandemic. The shift to mostly remote work has caused the FDA to adjust its approach to several regulatory activities, including postponing routine surveillance inspections of facilities.
On March 10, the FDA announced it would suspend international inspections until after April in response to the COVID-19 pandemic. Then, on March 18, Commissioner Stephen Hahn announced that the agency would also postpone inspections of domestically manufactured FDA-regulated products including drugs, biological products, and devices. Inspections deemed critical will be evaluated on a case-by-case basis. Commissioner Hahn acknowledged that inspections are only part of the strategy the FDA employs to ensure safety and quality are achieved. Product manufacturers are expected to continue to comply with current Good Manufacturing Practices, as required by US law, absent active FDA oversight.
Considerations for Ongoing Trials
The FDA also released guidance on March 18 regarding ongoing clinical trials affected by COVID-19 safety measures to reduce the spread of the disease through social distancing. The FDA offered several recommendations to ensure patient safety, maintain good clinical practices, and minimize the risks to trial integrity. Sponsors should focus on the potential impact on the safety of trial participants and protocols to modify study conduct accordingly. Suggestions include evaluating whether alternative methods to ensure participant safety (e.g., phone contact, virtual visit, alternative locations) could be implemented if necessary and when feasible. As such, the FDA recognizes that, in some instances, discontinuing administration of investigational products and participation in the trial may be in the best interest of participants’ safety, welfare, and rights.
Decisions about clinical trials will vary based on the specific circumstances of the trial and the nature of the volunteers involved. The FDA urges that trial participants are kept informed of changes to the study.
Sponsors should include the following information about the impacts of the COVID-19 pandemic in the clinical trial report, as appropriate:
- Contingency measures implemented to manage the study
- A listing of all affected participants with a brief description of how each patient’s participation was altered
- Analyses and discussions that evaluate the impact of contingency measures on safety and efficacy results
Importantly, COVID-19 screening procedures that may be mandated by the healthcare system in which a clinical trial is being conducted do not need to be reported to the FDA unless the sponsor is incorporating the data as part of a research objective. The FDA recommends that sponsors, clinical investigators, and institutional review boards consider establishing and implementing policies and procedures to protect trial participants and continue study oversight in anticipation of possible disruption caused by COVID-19.
The FDA is attempting to strike a balance between reducing regulatory barriers to the development of products to treat COVID-19, continuing regular product development for other important diseases and conditions, and maintaining routine regulatory activities to protect public health. Reducing non-essential safety inspections and providing more flexibility for clinical trial procedures are 2 measures the FDA has taken in response to the pandemic. However, the FDA has not yet released any information about delays in drug, biologic, or device approvals for products currently under review, nor has the agency commented on how changes to clinical trials may impact future drug approvals. While these revisions are responsive to the immediacy of the COVID-19 pandemic, the fact that clinical trials can accommodate greater flexibility while producing equally valid results to demonstrate safety and efficacy may have a bearing on future product development. Drug sponsors should continue monitor the situation when considering their product pipelines and use all available FDA resources and guidances as they become available.
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