Impact of COVID-19 on FDA Enforcement and Approvals – Part 5 – FDA Provides Update to Shape Expectations on New Approvals

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog posting this month, it was noted that FDA was devoting personnel to focus on COVID-19-related review efforts and that it was certainly possible that this might be a factor in delaying new approvals of non-COVID-19 medicines and devices. Yesterday FDA provided an update which affirms the possibility of delay. The fact that there was such an update would seem to indicate that the agency regards delays as increasing in likelihood.

Of note in yesterday’s statement the agency stated – With many staff working on COVID-19 activities, it is possible that we will not be able to sustain our current level of performance indefinitely. Our staffs are working at full capacity and we are striving to ensure that the drug programs continue to see minimal interruptions during this time. However, if there is an increase in drugs shortages and supply disruptions, we will be ready to reprioritize more of this work, as necessary.

And respecting devices, it seems to appear a little more certain that there will be delays: Additionally, with many staff in CDRH working on COVID-19 activities related to pre-Emergency Use Authorizations (pre-EUAs), EUAs, and Immediately In Effect (IIE) guidance documents, it is possible that we will not be able to sustain our current level of performance indefinitely. However, this will be assessed on an ongoing basis.

In the current environment, the only thing that can be said with certainty is that we are dealing with a great deal of uncertainty. The statement from FDA does not absolutely say that there will be delays, but that there are factors at play that make it more possible that there may be delays. It bears keeping in mind that not all new drug and new device applications are equal – in other words, while delays are possible and even probable, there are likely variables at play that will be highly influential on whether a particular application is delayed. But the communication from FDA underscores the possibility.

For the present it is a wait-and-see moment for each and every product in the pipeline. And in the longer term, to see what impact that this year will have on the future course of approvals as well as the standards by which products are reviewed.

Source link

Leave a Reply

Your email address will not be published. Required fields are marked *