Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused on enhancing the development of new treatments and presumably vaccines for COVID-19 called the Coronavirus Treatment Acceleration Program (CTAP).

According to the press release from FDA, Health and Human Secretary Alex Azar was quoted as saying that FDA would be “redeploying staff” in order to review potential new therapies. Staff from CDER and CBER will both be working to triage and provide support quickly with the underlying goal of maintaining FDA’s standards for evaluation of safety and efficacy on a fast-track basis.

There is certainly an urgency to develop strength in a “four-legged stool to address the pandemic. One leg involves the development of treatments that address symptoms of COVID-19 – both bringing new ones to market and assuring continued access to existing ones; one leg involving new therapies that directly address COVID-19; one additional one that is centered on vaccine development; and finally one that addresses diagnostics with rapid, reliable testing. The last has moved quickly in development. The others must move quickly.

Needless to say the current environment demands that COVID-19 development be priortized and facilitated. However, along with the pervasive interruption to clinical trials of non-COVID-19 therapies in research and development, the shift in resources to CTAP also signals that it may not be business as usual in the coming months with respect to the pipeline. This is true even where non-COVID-19 approvals occur as evidenced by the announcement last week that the approval of a new compound for MS would be delayed due to the COVID-19 pandemic.

In addition to shifting regulatory focus, research and development within industry is being deployed to the important task of the four-legged stool. The devotion of both research and regulatory assets and resources is extremely important but also factors in the equation when it comes to assessing the impact of this pandemic on the pipeline of new treatments – on research, regulatory review and even launch.

As noted in the last posting on this topic, I will continue to monitor and report out on developments.

Photo by Bill Oxford on Unsplash

This entry was posted in Current Affairs, FDA Policy. Bookmark the permalink.