Article Summary:
FDA Commissioner Marty Makary wants the same sense of urgency applied to the agency’s Commissioner’s National Priority Voucher (CNPV) program as was seen with Operation Warp Speed’s COVID-19 vaccine development. The CNPV program aims to expedite reviews of the chemistry, manufacturing, and controls (CMC) portion of drug submissions while therapies are still in clinical trials. Makary likened this to the efficiency of Operation Warp Speed, stating the agency should challenge assumptions that drug development takes 10-12 years and that manufacturing must be done outside the US.
Makary also discussed the FDA’s PreCheck program, which will designate its first company this summer. This program is intended to streamline oversight of certain manufacturing facilities based on national priorities, provide regulatory predictability, and encourage domestic factory construction.
Regarding technological innovations, Makary highlighted the agency’s use of AI to expedite application processing and reduce the need for animal testing. He noted FDA’s ELSA AI assistant and how computational modeling can predict drug interactions, potentially shaving 6-9 months off development timelines. The FDA has also loosened animal testing requirements for monoclonal antibodies and other drugs, instead relying on real-world data and New Approach Methodologies.
Lastly, Makary said the FDA is updating guidance to ease oversight of general wellness devices and clinical decision support software, allowing the agency to “get out of the way” for consumer-grade products while maintaining oversight for medical-grade devices.