Impact of COVID-19 on Regulatory Enforcement and Approvals

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one of them. And some of them are likely to impact timelines for the approval of new products.

Last week, FDA took the profound step of announcing that the agency would be “postponing” foreign inspections of facilities given the realities of the pandemic stating that this would be in effect until the end of April. Acknowledging that the decision would impact product application reviews, the release stated that “most” foreign inspections would be postponed and that those deemed mission-critical would be considered on a case-by-case basis. The agency cited as a factor in its decision the confidence had in the use of alternative methods and tools of enforcement. The term “mission-critical” was not defined. As the virus spreads domestically, it also calls into question how the agency will be forced to further pull back its activities.

For example, regarding advisory committee meetings and other public meetings, the alternative methods and tools do not appear to be available. One wondered if the agency was equipped and ready to conduct these meetings virtually. After all, if university courses can be taught virtually is there ability to conduct an interactive session among the advisory committee members with input from the public. The answer at this time would appear to be not. The word “postpone” is the watchword of the day. And in fact, the FDA calendar there have begun to appear notices that meetings are being postponed.

A meeting of the Non-Prescription Drugs Advisory Committee that was to have been held March 11 was postponed. On the meeting notice page, there was a message inserted that said that the meeting would be postponed until further notice due to extenuating circumstances. A second advisory committee meeting – the Blood Products Advisory Committee – to be held April 3 is also postponed, but a meeting set for April 16 has not yet been postponed nor have any meetings scheduled after that date. Meanwhile there are workshops that are scheduled for as soon as March 23, and one presumes that they, too, will be postponed, but there is nothing up on the site as of yet.

The impact of the inspections issue and the postponed advisory committee meetings are both likely to impact the ability of the agency to meet approval commitments. But an unknown factor is the capability of the agency to support its large workforce to work remotely, which would obviously affect the consideration of new drug applications where there are not advisory committee meetings being held, among other things. Domestic enforcement efforts also becomes a question. This year had seemed poised to bring out a robust number of new medicines, but that is now in some reasonable question.

FDA has a lot on its hands right now and emphasis is obviously on facilitating the production and use of test kits for COVID-19 and doing everything to speed and encourage treatments and vaccine development. That said, the communications around the regulatory process and approvals here in the U.S. needs clarification, and should be consistent and credible. Specifically does

• How much impact will the inspection issue have on approvals?
• Does FDA plan on attempting to conduct advisory committee meetings virtually at some point in the future?
• Will PDUFA dates be missed, or will they be extended due to the crisis?
• Is the FDA workforce working remotely and if so, how well-equipped is the agency to accommodate that? Hopefully in the coming days, the answers will be available.