New Drug Manufacturing Data Reporting Delayed: FDA

FDA says it is delaying collection of new drug manufacturing data to help it track potential drug shortages until an electronic data submission portal is established, which will not be ready by the 9/23 target date. The new reporting requirements are mandated under section 3112(e) of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act included authorities that enhance FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing FDA’s visibility into drug supply chains. Specifically, it requires that each registered drug establishment annually report the “amount of each drug . . . that was manufactured, prepared, propagated, compounded, or processed” by the registrant for commercial distribution.” FDA says it is working to define the data to be reported, create an electronic portal for the submission of the information, and determine when to begin collecting it.