Healthcare Innovation: Regulatory Trends in the Time of Covid-19 (Series 2 of 3)

Past FDA Methodologies and Documentation Procedures Are Out The Window, as FDA Embraces Remote Work Too 

As the race to fight COVID-19 is underway, the pandemic is profoundly impacting the FDA approval processes and ongoing clinical trials. In an effort to prioritize COVID-19 diagnostics and treatments, the FDA has allowed for changes to ongoing clinical trials and has introduced new procedures, such as Coronavirus Treatment Acceleration Program (CTAP), to reduce approval waiting periods. 

Regulatory Approval 

The FDA is trying to prioritize their efforts so COVID-19 diagnostics and treatments get to market as quickly as possible. As expected, in mid-March 2020 the FDA noted that all face-to-face meetings have been converted to teleconference. One historic challenge with the FDA is that the review team has already discussed the advice they will give to you (and your company) with the FDA Director. Therefore, it is very unlikely in a face-to-face meeting that they will make major changes or concessions because they will not have the chance to confer with each other or the Director in real-time. The advantage now to not being able to conduct face-to-face meetings is that the FDA review team go on mute, discuss the topic, and make real time adjustments. 

Review periods so far have been largely unaffected thanks to remote meetings, but site inspections were canceled for several weeks and are only now starting as of the end of May 2020. There have been some delays as the FDA is prioritizing the review of COVID-19 related products. Instead of the normal 60 day review period, we are now expecting 75-90 days. 

Ongoing Clinical Trials

In regards to clinical trials, the FDA produced and repeatedly updated a guidance document which addresses the immediate impact in 3 categories: (i) healthcare workers and patient safety, (ii) telemedicine and remote visits, (iii) missing data. In summary, if companies are concerned with patient or provider safety they can make changes to their trial(s) right away, with internal justification. In addition, they can add a site to enable the study-mandated patient visit to occur in a new location.

Furthermore, the FDA will entertain any reasonable description of missing safety and efficacy variables, and will find ways to adequately evaluate that. So in mid-trial, if companies need to make changes to data collection, they should do what they can to prospectively define those changes. There is also a significant benefit to utilizing telemedicine and other remote data tools to adapt ongoing clinical trials. It is important to keep in mind that this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

Newly Established CTAP 

The Coronavirus Treatment Acceleration Program (CTAP) is a special emergency program the FDA put in place to reduce the approval times and triage the massive influx of COVID-19 related approval requests. “As of April 16, 2020, FDA received 950 inquires and proposals concerning COVID-19 related drug development” per the FDA website. CTAP also defines in a pre-submission or in a pre-IND (Pre-Investigational New Drug Application) they would accept a combined meeting request and briefing document, thereby combining steps and remarkably reducing timelines. 

For all companies who submit a CTAP, it is encouraged to be very crisp in the definition of the protocol and state that you are collecting for this specific purpose. FDA uses the phrase “submit information in a combined format and be concise”. They are looking to act quickly on your behalf, but to do so, they need concrete, specific information.

Long-term Effects on U.S. Regulatory Approval Process

We are now seeing rapid decision making and action from the FDA, and they have proven their ability to pivot very quickly, and with a high degree of communication. There are many things to learn from this current environment, and it will be very difficult to justify having long review periods again a year from now.

Interestingly, a positive outcome of COVID-19 could be that it will improve data sharing and collaborations that wouldn’t normally exist. From this terrible public health crisis, we may actually learn how to better improve human health. For example, how to better manage worker safety in labs, or how to share ideas and data that allows us to develop better products, more quickly.

 

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