My last installment discussed observations regarding long overdue changes to 21 CFR needed to promote innovation and flexibility in response to local, regional and global stressors such as the current COVID-19 pandemic. While we await legislative acts that will hopefully modify and modernize 21 CFR, this article highlights some of the temporary actions taken by the U.S. Food and Drug Administration (FDA), under the current construct, to aggressively respond to the realities of COVID-19.
The FDA issued the first of many public statements on the coronavirus in late January 2020 announcing their high level response plan to industry and the public. The announcement included an indication of their intent to utilize the only real organizational tool they possess to adapt to emerging situations. The FDA commissioner has the authority to bypass the standard approval process, and allow release of unapproved therapeutics, diagnostics and devices via emergency use authorization (EUA). This tool was designed to be used when the risk of a lack of products, outweighs the risk of the supply of products that have not been fully vetted in accordance to the standard approval requirements.
Since that time, the FDA has approved many critical EUAs, including, but not limited to:
The FDA created the Coronavirus Treatment Acceleration Program (CTAP) to use every available method to bring new treatments to patients as quickly as possible, abbreviating but theoretically not compromising the existing clinical trial methods.
As of late April 2020, this program incorporates 72 active trials of therapeutic agents and 211 development programs for therapeutic agents in the planning stages.
This program involves:
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The FDA has an enormous amount of discretion under the current structure of 21 CFR, and they communicate their internal and non-legally binding policies on use of that discretion through the issuance of guidance documents to industry. The pace of release of these policy documents has dramatically increased since January 2020.
The FDA has always integrated with partner agencies on information, but the extent to which those partnerships have been utilized has increased and become critical to the integrated national response.
Under normal circumstances, the FDA plays a passive role for monitoring potential supply chain disruptions. 21 CFR requires that manufacturers of drugs (but not devices) notify the FDA of impending product shortages. Upon notification, the role of the FDA is limited to providing public notification. The agency has no role to play in pro-actively monitoring conditions that may cause these shortages, or in resolving them. And most significantly, the legal requirement for notification of the agency, did not extend to medical device manufacturers. Under the current crisis conditions, the FDA has proactively integrated with the private sector to play a more active role in predicting and mitigating product shortages. The following are among the most significant actions that they have taken:
There will be ample time to look back and measure the success of the agency’s efforts to balance the risk of action and inaction when the immediate danger to the public has passed, and to review all of the knowledge acquired. However, there are some aspects of the FDA’s pandemic-specific (temporary) actions and more importantly, of those not-taken that suggest the following topics will need to be addressed in the very near term.
Some of these include:
It is imperative that once the immediate danger passes that we take the opportunity to conduct in-depth analysis of not only the agency’s actions taken in response to COVID 19. At the same time, it’s critical that we also evaluate 21 CFR’s capacity (or lack thereof) to enable authorities to swiftly and effectively function during a public health crisis.
A post-COVID-19 response analysis should minimally include identifying:
The results of the evaluation should be used to define and implement permanent changes to the federal code. Those much-needed modifications will help us move toward a regulatory model that builds redundancy into the supply chain and provides procedures to act swiftly during a medical crisis rather than relying solely on executive orders or individual use of temporary emergency powers.
Gina Guido-Redden is a quality and regulatory professional with over 25 years of domestic and international industry experience. She is the co-founder and chief operations officer of Coda Corp USA, which provides consultancy services to pharmaceutical, biologics and medical device firms.
Guido-Redden’s history specializes in the areas of facility start up, regulatory compliance and remediation, quality system development, mentorship and training, quality system design, and implementation and management.
She is also a quality systems subject matter expert (SME), frequent seminar presenter, and content contributor to industry publications, including GAMP’s White Paper on Part 11, The Journal of Validation Technology, New Generation Pharmaceuticals, Computer Validation Digest, and MasterControl’s GxP Lifeline. Coda Corp USA is an enterprise partner of MasterControl.