On August 6, 2020 President Trump signed an Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States.  The Executive Order states that “the domestic supply chains must be capable of meeting national security requirements for responding to threats arising from CBRN (chemical, biological, radiological, and nuclear) threats and public health emergencies, including emerging infectious diseases such as COVID-19.”  Further, it directs the executive departments and agencies that are involved in the procurement or Essential Medicines, Medical Countermeasures, and Critical Inputs to consider how to increase domestic procurement.  Federal government agencies are directed to purchase these items from companies in the U.S. instead of foreign firms.

The Executive Order does not provide a list of drugs and supplies that fall under the requirement.  Instead, the FDA commissioner is instructed to identify the initial list of Essential Medicines, Medical Countermeasures, and Critical Inputs.  In turn, the United States Trade Representative is directed to “take all appropriate action to modify United States Federal procurement product coverage under all relevant Free Trade Agreements and the World Trade Organization Agreement on Government Procurement to exclude coverage of Essential Medicines, Medical Countermeasures, and Critical Inputs.”    Notably, there is an exception that grants authority to heads of agencies to determine that certain requirements under the Executive Order where:

  • their application would be inconsistent with the public interest;
  • the relevant Essential Medicines, Medical Countermeasures, and Critical Inputs are not produced in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality; or
  • their application would cause the cost of the procurement to increase by more than 25 percent, unless applicable law requires a higher percentage, in which case such higher percentage shall apply.

There is also an exception for items necessary to respond to a public health emergency, major disaster or emergency, or national emergency.  The Secretary of HHS, through the FDA commissioner and in consultation with the OMB Director is required within 180 days to identify vulnerabilities in the supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs, and to mitigate the identified vulnerabilities.  The Environmental Protection Agency Administrator is instructed to identify requirements and guidance documents that can be streamlined in order to advance domestic production of Critical Inputs. The Executive Order will require significant coordination amongst federal agencies and is not binding.

Norton Rose Fulbright attorneys will continue to provide relevant updates for healthcare providers on the Health Law Pulse related to the COVID-19 pandemic.