On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic medical supply chain is capable of protecting the country’s citizens, infrastructure and economy against outbreaks of emerging infectious diseases and chemical, biological, radiological and nuclear (CBRN) threats. The EO’s multipronged approach contains four primary goals: (1) accelerating the development of cost-effective and efficient domestic production capacity and supply chain redundancy of Essential Medicines, Medical Countermeasures and Critical Inputs (EMMCCI); (2) ensuring long-term demand for EMMCCI that are produced in the United States; (3) creating, maintaining and maximizing domestic production capabilities for critical inputs, finished drug products and finished devices that are essential to public health and safety; and (4) combating the trafficking of counterfeit EMMCCI.
The EO sets forth a process to advance these goals by directing a range of actions by various federal agencies over the course of 180 days. At its core, the EO directs a range of federal agencies, using a variety of tools and authorities, to identify the types and amounts of EMMCCI medically necessary to have at all times and to assess and support the ability of the government to procure designated EMMCCI that is produced in the United States. To put it another way, the EO seeks to apply Buy America policies to the U.S. government’s acquisition of EMMCCI through procurement contracts and in the process create a specific market for domestically sourced EMMCCI. An undertaking of this nature—with such far-reaching implications and on this timeline—is perhaps without precedent. Also, it is unclear whether the federal government’s payment rate will be enough for manufacturers to forgo current production lines and pursue these types of contracts. Set forth below is an overview of key milestones contained in the EO as well as a synopsis of other key provisions.
(1) Consider proposing regulation or revising guidance on the collection of certain information from manufacturers of EMMCCI as part of the application and regulatory approval process, including: (i) the sources of Finished Drug Products, Finished Devices and Critical Inputs; (ii) the use of any scarce Critical Inputs; and (iii) the date of the last FDA inspection of the manufacturer’s regulated facilities and the inspection results.
(2) Entering into written agreements with the National Security Council, Department of State, DOD, Department of Veterans Affairs and other interested agencies to disclose records regarding the security and vulnerabilities of the supply chains for EMMCCI.
(3) Recommending to the President any changes in applicable law that may be necessary to accomplish the supply chain security objectives.
(4) Reviewing FDA regulations to determine whether any of those regulations may be a barrier to domestic production of EMMCCI and advising the President whether such regulation should be repealed or amended. (Sec. 3(a)).
The EO provides an exemption to requirements related to procurement and procurement product coverage under modified free trade agreements and the WTO Government Procurement Agreement in two cases: