medical countermeasures

The world has been almost singularly focused on the 2019 coronavirus for more than 18 months now, but the fact remains that we still face an array of other known pathogens with pandemic potential and any number of unknown pathogens that could pose a similar risk.  These threats have periodically been an area of congressional focus since the 2009 H1N1 influenza pandemic, and most recently a bill for the Disease X Act would renew this focus and direct it at new, currently unknown viral threats.  The bill is poised to be a key piece of legislation in ongoing and future biodefense initiatives and pandemic preparedness.
Continue Reading The Next Pandemic: New Bill Looks Ahead to Counteract Novel Threats

Last week, President Trump issued an executive order aimed at encouraging the expansion American manufacturing of essential medical products — Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) (the “Order”).  The Order sets forth an ambitious plan requiring extensive agency action on a tight timeline that suggests a significant impact.  Closer examination of the Order raises significant questions about the practicalities of implementation and the realistic impact of the Order once the substantial stated exceptions are taken into account.

The List

The heart of the Order is a list of Essential Medicines, Medical Countermeasures (“MCMs”), and Critical Inputs to which the Order’s requirements apply — but the key components of this list do not yet exist.  Instead, the Order directs the Food and Drug Administration (“FDA”) to produce the list within 90 days and to include on the list Essential Medicines, MCMs, and Critical Inputs “that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.”

The Order provides the following definitions that give some insight into what may be on the FDA’s eventual list:
Continue Reading Trump Administration Increases Uncertainty for Pharmaceutical Manufacturing