March 19, 2020
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.
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
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.