Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2

Empty FDA Advisory Committee Meeting Room

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose questions to FDA regarding the impact of the current circumstances on future approvals and the ability to meet PDUFA dates in a timely manner. The Center for Drug Evaluation and Research (CDER) responded as specifically as they apparently could under the circumstances. Bottom line – it would appear that while disruptions to the approval process are possible, the agency is operating and attempting to put into place measures to mitigate disruption. And while virtual AdComms are not a certainty, it would also appear to be something that is possible – at least they are thinking about it.

Here is what they said verbatim:

  1. What is the expected impact on approvals of the recent decision to postpone inspections? On 3/18/2020, for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we announced that we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks, and other public health emergencies involving FDA-regulated products. Importantly, during this interim period we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protecting both the firms and the FDA staff. This can include, among other things, evaluating records in lieu of conducting certain onsite inspection on an interim basis when travel is not permissible, when appropriate.
  2. Does FDA plan on attempting virtual advisory committee meetings? As this remains a dynamic situation, we will continue to assess and calibrate our approach. Where possible the agency will leverage technology to host meetings allowing for remote participation. We thank you for your patience. In considering necessary steps for protecting public health, including our sponsors, our committee members and our workforce, we are cancelling or postponing all non-essential meetings through the month of April. We will reassess on an on-going basis for future months. Where possible the agency will leverage technology to host meetings allowing for remote participation.
  3. Is there an expectation that PDUFA dates will be missed, or will they be extended due to the crisis? CDER is fortunate to have existing policies on the use of flexible workplaces, as well as the IT infrastructure to support a large number of staff simultaneously working offsite This gives us the ability to ensure the safety of our workforce and the continuity of our important public health mission during government disruptions. CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak. As this remains an evolving and very dynamic situation, the FDA will continue to be flexible and transparent as possible.
  4. Will new drug applications be considered during this time when presumably the FDA workforce is working remotely? CDER continues to perform our drug review activities as well as contribute to other vital functions of the Agency. As you may know, we are working around the clock to monitor and mitigate emerging coronavirus-related issues with our federal partners, international regulators and medical product developers and manufacturers to advance response efforts to combat the coronavirus disease (COVID-19) outbreak. Our application review teams remain focused on their work, and we are doing everything possible to maintain continuity of operations in a very dynamic situation.

What do we know from this? The situation we are presented with means that certainties in any conversation are off the table given the situation we are facing. But what this tells us is that the FDA workforce is equipped to work remotely. It does say the agency is striving to find alternative means to do what it cannot do in person and to meet the necessities of the review process. It does foreclose the possibility of delays, but affirms that efforts are going into getting work done as usual. That means that we will not really know for certain until upcoming PDUFA dates come and go. To that end, I track all the dates of which I am aware and record decision dates and will let you know that tells us as we tread further along in this environment.

Be well. Be safe. Be kind.

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Source: lpwt

Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2