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What COVID-19 May Mean for Future FDA Regulatory Oversight

Summary

The FDA has adjusted its priorities in response to the COVID-19 pandemic and the agency is expediting decisions on testing, therapies, and vaccines on a daily basis.

The crisis necessitates innovative approaches to FDA review and approval practices and activities, which are now occurring in parallel but historically occurred in series. The FDA is more aggressively applying public health perspectives, including public statements that address the COVID-19 crisis specifically. However, the impact on other FDA activities remains important to consider too. The agency continues its normal activities of approving products and ensuring the safety of supply chains while simultaneously providing oversight to expedite products and procedures necessary for the COVID-19 pandemic with no immediate change in resources. Understanding the short- and long-term impacts of the pandemic on FDA resources is an important consideration for drugs, biologics, and device product pipelines, especially as discussions begin for the next round of user fees.

COVID-19-Specific Changes

The FDA made its first public announcement about COVID-19 on January 27, describing its commitment to responding to growing public health threats. In the announcement, the FDA also provided basic information about the availability of the Emergency Use Authorization for diagnostic test sponsors and opportunities for sponsors developing therapeutics to submit information through the Pre-Investigational New Drug Consultation program. Since then, the FDA has expanded its oversight related to COVID-19 activities by making announcements and releasing guidance about test kits and therapeutics, use of ventilators and personal protective equipment (PPE), and sterilization procedures. The agency’s actions have been swift and communicated through its website.

On March 31, the FDA announced the initiation of the Coronavirus Treatment Acceleration Program to expedite therapeutic development. This includes the agency redeploying teams to work on accelerating protocols and single patient expanded access requests. Redeployment means a shift in existing resources rather than new resources and additional personnel. FDA employees who normally oversee reviews for other products are now working on COVID-19 related activities. Whether this shift will have effects on FDA drug, biologic, and device approvals is unknown but seems likely. Thus far, the FDA has continued approving medical products unrelated to the pandemic with minimal disruptions.

Impact of COVID-19 Mitigation Strategies

FDA has taken action to comply with federal regulations to mitigate the effects of COVID-19, resulting in changes to standard protocols. A recent Avalere analysis describes steps taken by the agency in March to provide guidance about ongoing clinical trials affected by safety measures. Clinical trials may be halted or altered to ensure safety of trial participants and free up resources for ill patients. Additionally, those enrolled may need to be tested for COVID-19, which may ultimately be a confounding factor for results from trials. The FDA has not yet commented on how it will review approval packages that include clinical trials that were altered by the pandemic, but these decisions will likely have lasting impacts on drug development.

Supply chains have been affected by the global pandemic as product development slows due to the virus, and FDA oversight of these activities has also stalled. Not only are employees of manufacturing and distribution facilities partaking in social distancing or becoming ill, but the FDA also postponed foreign inspections through April. In the US, the agency announced it has postponed routine inspections to protect its employees from the outbreak and is relying on the industry to continue monitoring safety of their supply chain. This reliance during a pandemic, if it works well, suggests the FDA may be able to perform fewer inspections and instead work with industry to comply with Current Good Manufacturing Processes from a distance.

Some actions taken by the FDA are likely pandemic specific. Allowing use of PPE more than once and the leniency of sterilization are likely linked only to the pandemic and shortage of supplies. Additionally, the extremely accelerated approval to enable access to drugs is an effort to shorten the length of the pandemic. These actions are drastic given the current urgent needs and are unlikely to be continued once the pandemic ends (although whether SARS-CoV-2 will become endemic is as yet unknown and may affect future agency policies).

Potential for More Efficient and Effective FDA Oversight Post-COVID

The FDA has created new opportunities for streamlining procedures and updating processes as a result of the global COVID-19 pandemic. One way sponsors have complied with clinical trial changes is by incorporating telehealth into their trial designs. When the pandemic abates, telehealth will likely continue to be an opportunity to improve patient access to investigational products, as well as approved products as part of post-approval monitoring. There may also be opportunities for real world evidence to be leveraged more effectively during the pandemic as a result of the rapid development of new tools for patient monitoring and as a way to capture data remotely.

FDA oversight of procedures performed with devices in person have been updated as well. For example, on April 6, the FDA released guidance about remote ophthalmic assessments and monitoring devices. An openness to virtual use of diagnostics may continue, assuming such use is seen as successful and expedient. Nonetheless, this should not be assumed, and the thorough documentation on outcomes will be advantageous in the event sponsors need to collaborate with the FDA at a later time.

The FDA has converted meetings and conferences into virtual engagements. Some of these meetings will possibly be completed virtually in the future as well, which likely reduces the burden of travel on sponsors and other stakeholders invested in product development. However, face to face meetings yield a different level of engagement and are unlikely, for example, to replace all FDA Advisory Committee meetings.

Unrelated to the response to the virus, the CARES Act modernizes the FDA’s review of over-the-counter (OTC) medicines, including a new user fee, which should expedite the process for their review, and an 18-month exclusivity for new OTC products. These regulatory frameworks have been in the works for some time.

This disruption at the FDA has forced a reprioritization of decision making at the agency. However, this can enable more efficient product development and regulatory review in the future, well beyond the immediate crisis. It will be up to all stakeholders to show which aspects of current changes make the most sense to continue long term.

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