Avalere: FDA can impact COVID-era drug development

While the COVID-19 pandemic has significantly impacted nearly every global industry, the drug development and clinical trial industries are wrestling with unique challenges. As professionals struggle to continue their work with as few interruptions as possible, the US Food and Drug Administration has served as a source of information and guidance.

Outsourcing-Pharma (OSP) recently spoke with Kelly L. George, PhD, RAC (KG), consultant with Avalere, about actions and advice coming from the FDA, and what might lie ahead.

OSP: Could you please summarize and offer your perspective on the FDA’s actions and guidance’s related to COVID-19, pertaining to drug development and clinical trials?​

KG: The FDA is attempting to strike a balance between reducing regulatory barriers to the development of products to combat the SARS-CoV-2 pandemic, continuing regular product development for other important diseases and conditions, and maintaining routine regulatory activities to protect public health. This is a difficult situation and one where FDA, like all of us, has evolved as more data is aggregated to enable the most educated decisions and policies. 

OSP: How is the postponement of routine inspections impacting the industry, and how might it impact the industry down the road?​

KG: The agency 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. The agency never comments publicly on individual applications.

However, comments by Commissioner Hahn released on April 16th are notable and may suggest FDA is preparing for a potentially significant impact. Postponement of any step along the approval pathway may lead to delays in patient access--though, to the extent that FDA is able to accommodate greater regulatory flexibility while maintaining the same standard of approval, lessons learned during the public health emergency may lead to enhanced efficiencies down the road.

OSP: Clinical trials obviously have been shaken up by the pandemic—could you talk about how the FDA guidance addresses that?​

KG: The FDA is and has been well aware that the impact on clinical trials may be considerable. Both the original guidance and the updated version (March 16th, April 17th) do focus primarily on the safety of the trial participants.

Yet, a great deal of emphasis is also given to the importance of documentation and communication with FDA, IRBs and Independent ethics committees presumably with the foresight of ensuring trial integrity and retaining data which can be used for regulatory decision making in the future. It is nice to see FDA reaching out to sponsors in this manner.

OSP: How can sponsors help minimize the negative impact of the pandemic—technology, protocol, patient engagement practices, anything you’d like to discuss is welcome​

KG: It is important that the other products in development continue too – and FDAs flexibility during COVID-19 is indicative of both their overall regulatory authority and their ability to prioritize public health as well as individual patients needs

OSP: Can you share any examples of how Avalere has helped a company weather the COVID-19 storm and minimized negative impact on their work/project?​

KG: We work across the breath of the health care industry and it is impressive to see how all sectors are stepping up to mitigate this pandemic

OSP: Is there anything else you’d like to add?​

It is crucial that the lesson learned during COVID-19 are integrated into our health care system to give us much better capabilities should this pandemic continue and, in the future, other such situations arise.