In certain situations, the Food and Drug Administration (FDA) allows companies to provide their Experimental Drugs and Devices to people outside of clinical trials. This is referred to as compassionate use. But getting access to not-yet-approved drugs through a compassionate use request can be a long and challenging process. In coming days, the Food and Drug Administration is likely to authorize new COVID-19 vaccines based on applications submitted by two companies. These authorizations have happened very fast in a process called “emergency use authorizations,” or EUAs. Does this swift action mean that products are proven safe and effective? Not exactly. But it suggests that they may present a reasonable balance of risks and benefits.

The pandemic has placed a strain on health systems, including pharmacovigilance systems, worldwide. The available systems were probably not ready to handle an emergency of such large proportions and with such unpredictable characteristics. The role of pharmacovigilance in the management of such emergencies is crucial, specifically the appropriate use of Experimental Drugs and Devices proposed to treat the disease and the management of actual or potential consequences of inappropriate use of the same drugs.

Nonclinical toxicology is an important component in the drug development process and ensures that safe drugs are made available to people. A sound nonclinical toxicology program should address all regulatory authority concerns and ensure that time and resources are properly used.

Rapid research and development efforts in 2020 demonstrated that bio/pharma companies must be positioned to move swiftly through the drug development process with unwavering commitment and oversight to ensure the compounds slated for the clinic are safe. The combined efforts of pharmaceutical companies, governments, and CROs were instrumental in reducing the development timeline from a decade or more to one year for some R&D programs. Time will tell what impact the current pandemic has on the overall approval for all therapeutics for all diseases outside of a global pandemic, but regardless of what these changes bring, safety will always be a priority.