|
FDA’s New Approvals Were Not Affected by the Pandemic
(Thursday, January 27, 2022) Last year FDA approved the same number of new drugs as the previous two years demonstrating that the pandemic related disruptions did not affect the timelines for the new drug approvals. Also, like previous years more than half of the approved new drugs were intended for rare or orphan diseases and almost three-fourths (74%) of the approved products used one or more of the expedited approval pathways. FDA was also the first regulatory agency in the world to approve 38 of the 50 new drugs it approved. These numbers are very interesting for several reasons. First, while the pandemic has been devastating to clinical trials with more than half of the clinical trials stopped for varying periods of time and then limping back to partial resumption at best, and many new clinical trials not being able to even initiate, it may be too soon to see the effect on the new drug applications submitted to the FDA. Typically, it could take a year or more between the end of the final clinical trials and the submission of the NDA application, and another year before the FDA review timeline is up. So, it may take a few years to truly see the impact of the pandemic related disruptions on the new drug development. Second, since more 74% of the products used one or more expedited approval pathways for review, it is quite possible that they had truncated clinical trial and non-clinical data requirements, skewing the results a bit. Expedited approval designations allow flexibility for the FDA in terms of data requirements. One can argue that almost two-thirds of the products were approved with bare minimum data. Also, since more than half of the drugs approved were for rare diseases which frequently involve smaller dedicated group of patients, the disruption of those trials is harder to occur. Third, most of the FDA staff moved to remote office protocols almost from the first days of the pandemic so there was practically little disruption in the review process as FDA reviewers were able to access all documents from their home offices. FDA has been moving to electronic documents for more than a decade. Incidentally, 2020 was the year when almost all of FDA review processes were supposed to be fully electronic. The timing of the pandemic was hence serendipitous for FDA. It was easier to move its processes remote unlike regulators in other countries who had to scramble to move their tasks to remote format after the pandemic lingered. Still, it is commendable for FDA to stay on time more than 98% of the time. FDA may have many things working in its favor when counting its performance, but these criteria were not invented by the pandemic, rather are the results of years of planning. Kudos to FDA for that. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
|
|
|
