In light of the urgent need for medical intervention during the coronavirus pandemic, the Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), has taken action to increase the supply of respirators available to healthcare providers and provide new guidance on the conduct of clinical trials.
N-95 Respirators Expiration Dating and Additional Authorizations
On March 3, 2020, both the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration stated that it is permissible to use N-95 respirators regulated by National Institute for Occupational Safety and Health (NIOSH) for healthcare settings.
FDA granted CDC’s emergency use authorization, as requested, because FDA concluded that NIOSH respirators may be effective in preventing inhalation of COVID-19 viral particles. This means hospitals and healthcare providers looking for masks can also consider NIOSHA-approved respirators in the clinical setting. For manufacturers of NIOSH-regulated N-95 respirators, it means sales of these respirators for prevention of COVID-19 transition may be authorized during the national emergency. In all other times, FDA approval would be necessary to introduce an N-95 respirator to market because it is a Class-II device, which requires FDA notification.
Additionally, CDC and FDA have stated that certain models of N-95 masks may have efficacy past their expiration dates and could be considered for use after visual inspection.
FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic
On March 18, FDA released “FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards” (CT guidance). FDA recognizes the need to reassess compliance with protocols and human subject protection in light of the current national crisis. In the CT guidance, FDA emphasized the following considerations for ongoing clinical trials.
- Safety first. Study decisions should take into account the impact on the safety of all clinical trial participants. This could also include continuing use of an investigational product for patients already in the trial. These decisions are best made in consultation with an Institutional Review Board (IRB) or Independent Ethics Committee after considering the risk associated with discontinuing the product and the best way to protect the safety, welfare, and rights of the study participant.
- Keep all study participants informed about what will happen to the study and their participation.
- If a clinical trial participant cannot come to the site, consider alternate methods for contact (phone, virtual visit, alternate location). Are in-person visits really necessary, given COVID-19?
- For cases where a drug is discontinued, FDA stressed the need to continue to monitor withdrawal or adverse events from the cessation of an investigational treatment.
- COVID-19 screening procedures are likely not necessary to report as a protocol amendment unless they are part of a new research objective.
- Change first and then report. Protecting the health of the study participants is paramount. Changes that minimize immediate hazards do not require immediate reporting to an IRB or filing of an amendment for protocol change; this can be done after the fact.
- Stick to the protocol as much as possible, but note the deviations related to COVID-19. Note also the reasons why efficacy endpoints were not collected and the COVID-19-related reasons for this.
- Sponsors and investigators should work with FDA to inform the agency of changes taking place to the trial, and work with the IRB to ensure protection of trial participants.
- In the clinical study report, sponsors should describe to FDA the following information related to COVID-19:
- The contingency measures implemented
- A list of all participants impacted by COVID-19 study-related disruptions, by unique subject identification numbers and by study site (noting how the participation was altered)
- Analysis of how the COVID-19 changes would impact safety and efficacy of the investigational drug or device
Practically speaking, sponsors, IRBs and investigators should work in unison regarding any clinical trial changes. Subject safety is the highest priority and should be emphasized above all else, but balanced in terms of risks and benefits for the participant.
Great examples of sponsors quickly adapting to social-distancing norms include mailing drugs to patients, measuring results remotely and figuring out workarounds for various paperwork issues. It is important to keep in mind, however, that when adapting isn’t feasible and trials must be halted, force majeure provisions may be triggered.
McGuireWoods has specific experience working with and handling issues in clinical trials. Please reach out if we may assist further.
Helpful Resources
- FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards. March 2020,
- FDA Equipment Shortage FAQs
- CDC Release of Stockpiled N-95s
McGuireWoods’ COVID-19 Response Team helps clients navigate urgent and evolving legal and business issues arising from the novel coronavirus pandemic. Lawyers in our 21 offices are ready to assist quickly on questions involving healthcare, labor and employment, education, real estate and more.