The rapid spread of COVID-19 has posed an unprecedented challenge to healthcare providers and the public health community. The COVID-19 pandemic has an immense societal impact and has called for an all-out public health response. There is an urgent need for rapid data collection and dissemination of medical information associated with COVID-19 to the medical and public health community, including treatments to combat the disease.
Treatment for COVID-19 has included both the new use of established medications and the emergence of novel therapeutics. The advancing knowledge of COVID-19 mechanisms has led to a rapid pace of evolving treatment methods with very little prior scientific evidence or proven dosing regimens. The risk of increased adverse drug events (ADEs) is evident, and there is a need for enhanced monitoring.
The Toxicology Investigators Consortium (ToxIC) is a multicenter medical toxicology surveillance and research network. With sites across the United States, in every federal region, ToxIC is well-positioned to support enhanced surveillance in diverse populations. Safety surveillance of adverse events specific for drugs and substances associated with the treatment of patients with COVID-19 is consistent with FDA’s mission of ensuring drug safety throughout the drug lifecycle. The FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project Sub-registry will provide a mechanism for enhanced collection of safety data related to drug therapies used in patients treated for COVID-19.
Funding for this initiative was made possible (in part) by grant number 75F40119D10031 from FDA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the FDA; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.