FDA delays collection of drug manufacturing volume data

FDA announced that it will not begin collecting drug manufacturing volume data in September, as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages. Drugmakers are also now required to report manufacturing volume data annually under Section 3112(e) to FDA, including “the amount of each drug … that was manufactured, prepared, propagated, compounded, or processed for commercial distribution.” The act gives the HHS secretary discretion to exempt biologics from some or all of the manufacturing volume data reporting requirements. While the requirements established under Section 3112 are set to take effect on September 23, FDA says the electronic data submission portal it intends to use will not be ready by then.