As noted in our blog post last week, FDA has issued several guidance documents authorizing the emergency use of medical devices and drugs to address the COVID-19 outbreak. These EUAs provide a streamlined approach for selling otherwise unapproved products intended to alleviate the national emergency. Today’s blog post describes a separate, but related, FDA initiative to alleviate companies’ postmarketing reporting obligations for their routine, non-COVID–19 related products during a pandemic. FDA recognizes that a pandemic can result in a shortage of staff (due to illness or stay-at-home orders), and seeks to prioritize both FDA and industry’s limited resources to manage the pandemic. This guidance provides regulated entities some relief on continuing business operations without fear of running afoul of FDA enforcement.
The Office of Counterterrorism and Emerging Threats, CDER, CBER, CDRH, and CFSAN all joined in issuing the guidance for industry titled, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.” These offices anticipate that “during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism,” at the same time that adverse events related to the pathogen causing the pandemic likely would increase. FDA states that it will exercise enforcement discretion (i.e., does not intend to object) if a company does not submit certain required adverse event reports within the time required by statute and regulation. FDA expects that any delayed reports will be submitted within 6 months after the pandemic ends and operations resume to pre-pandemic levels.
In the guidance, FDA emphasizes that companies should already have in place a Continuity of Operations Plan (COOP) to address all firm operations in the event of a pandemic. (Companies who may not have developed such a procedure pre-COVID-19, should prioritize this in advance of their next FDA inspection.) The COOP should address what happens if there is pandemic-related high employee absenteeism and require the company to maintain documentation of the declaration of the pandemic and the factors preventing the company from meeting its normal regulatory requirements (e.g., high absenteeism, increase in adverse event reports).
Specific to adverse event reporting, FDA sets forth its general premise that “normal adverse event reporting processes should be maintained to the maximum extent possible” during a pandemic. But the guidance details in Table 1 exactly which adverse event reports FDA will continue to require and those it will permit to be stored until the pandemic concludes. With some exceptions, FDA will only require timely reporting of events that are related to products that are indicated for the treatment or prevention of the pathogen causing the pandemic. FDA still requires reporting for deaths associated with drugs, biologics, blood and blood components, source plasma, and medical devices, and also requires timely reporting of adverse reactions associated with HCT/Ps or that would result in a 5-day MDR (i.e., those that necessitate remedial action to prevent unreasonable risk of substantial harm to public health). FDA also reserves the right to communicate special concerns about certain products that must be reported even during a pandemic.
FDA recognizes there may be a gap between when the pandemic is resolved and a pre-pandemic state is restored. But once both events happen, FDA expects companies to follow their COOP and generally plan to submit stored reports to FDA within 6 months on a prioritized basis (e.g., the reports with shorter time periods should be reported before the periodic, routine reports).
This guidance is practical in its approach and provides helpful assistance to those companies who simply cannot handle its regulatory obligations remotely. It also relieves pressure from companies who may otherwise be trying to develop solutions to directly address the pandemic, and are seeking to divert its limited resources internally. To take advantage of this guidance, in the short term, a company should be documenting any inability to meet its obligations to submit postmarket reports; in the long term, a company should develop a robust COOP to make seamless its decisionmaking should (heaven forfend) another pandemic occur.