critical inputs

This post continues our ongoing coverage of the FY 2024 NDAA. 

The FY 2024 NDAA includes numerous supply chain and stockpile management provisions aimed at addressing a host of perceived vulnerabilities and weaknesses in Department of Defense (“DoD”) supply chain networks used to secure goods and services for our national defense.  Of particular note, this year’s NDAA seeks to address China’s and Russia’s continued dominance in the global supply chain for many critical materials and rare earth elements.  Supply chain- and stockpile-related measures in the NDAA could present significant opportunities for contractors poised to support the U.S. Government’s efforts to on-shore and friend-shore U.S. and DoD sourcing and manufacturing, but Congress’s focus on increasing supply chain visibility could also herald new rounds of compliance and reporting requirements attached to federal procurements.Continue Reading Key Supply Chain Provisions of the National Defense Authorization Act (“NDAA”) for Fiscal Year (“FY”) 2024

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