“FDA awards a contract to the American College of Medical Toxicology (ACMT) to establish a COVID-19 Sub-Registry to collect data on the safety of drug products used for the prevention or treatment of COVID-19 infection”


December 3, 2020 — ACMT’s Toxicology Investigators Consortium (ToxIC) is a unique multicenter toxicosurveillance and research network comprised of physicians specifically qualified in the field of medical toxicology. Since the network’s establishment in 2010, there have been over 73,000 cases recorded into ToxIC’s Patient Registry from 40 participating sites across the United States comprised of more than 60 hospitals and clinics. ToxIC was designed to provide accurate, reliable and timely data on adverse effects arising from exposures to medications, drugs of abuse, natural substances, metals, pesticides, or other chemical substances.

The COVID-19 Sub-Registry will be developed as an enhanced data collection tool within the ToxIC network that will specifically focus on identifying potential adverse reactions related to COVID-19 drug treatments. Physicians specialized in medical toxicology will oversee the program at 15 designated medical centers across various geographic regions in the United States.

“ACMT is very honored to receive this contract from FDA for this important project related to medication safety surveillance,” said Dr. Paul M. Wax, ACMT’s Executive Director and cofounder of ToxIC. “For over a decade, ACMT has worked diligently to develop the ToxIC Program as a useful tool for adverse drug reactions and overdose surveillance.” Jeffrey Brent, MD, PhD, Co-Principal Investigator on this project states that “particularly now, in the midst of the COVID-19 pandemic, we anticipate this collaboration will deliver critical data that could improve public health decision making.”

The FDA has had a contract with ACMT to access the ToxIC Registry for three years. The new ToxIC Sub-Registry is designed to provide FDA’s Center for Drug Evaluation and Research (CDER) safety data related to drug therapies used in patients with or suspected to have COVID-19. ACMT will work in close collaboration with scientists in CDER’s Office of Surveillance and Epidemiology (OSE) and Office of Translational Sciences (OTS).