Today, President Trump signed an executive order (EO) requiring the federal government to purchase only domestically-produced "essential drugs" and medical supplies, including personal protective equipment. Based on the information shared during the press conference for the EO signing, the EO directs the Food and Drug Administration to determine what qualifies as an "essential drug" and provides exemptions for cost, availability, and public interest. It is also important to note that the EO does not appear to create any new government purchasing authority (i.e., Medicare and Medicaid will not be purchasing drugs directly).
ASHP strongly supports efforts to expand domestic manufacturing of medications and related supplies, including production incentives created through government contracting. ASHP also welcomes the creation of incentives for manufacturing techniques.
"ASHP absolutely agrees that it is vital to encourage domestic drug manufacturing, including through government purchasing. However, we are concerned that the EO would allow the use of the Defense Production Act to prioritize federal purchasing of domestically manufactured drugs, potentially disrupting health system access to critical drugs," said ASHP Vice President of Government Relations Tom Kraus. "We are committed to working with the administration to ensure the EO will not be implemented in a way that disrupts existing private sector supply chains that are vital to patient care."
ASHP will also urge that the EO not be a barrier to immediate replenishment of the strategic national stockpile. The United States continues to experience critical shortages of drugs used to treat COVID-19 patients, and replenishment of the stockpile should not be contingent on the availability of domestically manufactured drugs and supplies.
Because the EO requires some complex and coordinated regulatory work from FDA and other agencies, it may be some months before it can be implemented. ASHP will update members on implementation progress and provide feedback to the federal agencies to help ensure that hospital and health system supply chains are protected and that the EO results in a more resilient national supply chain.