Division Director Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, OTS, CDER, FDA Silver Spring, Maryland
During an infectious disease outbreak, decisions about therapeutics must balance the urgent public health need for treatments with the importance of a thorough evaluation of safety and efficacy. The global community of drug developers, regulators, and health care providers often make decisions in an evolving environment of scientific and medical knowledge. The foundational principles of clinical pharmacology- the right drug at the right dose for each patient- are key to achieving this balance. Due to the immediate need for therapy, drugs used during infectious disease outbreaks are typically repurposed, either previously approved or under development for other indications. A number of consideration are important when repurposing (or quickly beginning development) of a drug during an outbreak: (1) knowledge of the drug’s mechanism of action, (2) the drug’s activity against the pathogen of interest (if the drug is an antimicrobial), (3) the site of drug action, (4) the concentration of drug needed at the site of action, (5), the pharmacokinetic characteristics of the drug, (6) the range of patient populations likely to be affected, (6) patient co-morbidities that may alter disease progression and drug response, and (7) the likely settings of medical care. Application of clinical pharmacology information and principles helps leverage any available clinical information during emergencies. This approach has been used during Ebola outbreaks, the H1N1 influenza pandemic in 2009, and the current COVID-19 pandemic. Each experience teaches lessons that can be applied during the next outbreak. We can look to the decades of work addressing the AIDS epidemic as an inspiration for application of clinical pharmacology principles in an urgent and life-threatening scenario. The work we do today takes us a step closer to addressing future infectious disease outbreaks.
Describe clinical pharmacology considerations that are important when developing drugs to address an infectious disease outbreak
Describe factors to consider when making a risk/benefit assessment of therapies during an infectious disease outbreak
List lessons from previous infectious disease emergencies that can benefit the response to current and future emergencies