FDA Creates List Of National Essential Medicines For Times Of Emergency
Following an executive order issued by President Donald Trump, federal regulators have published a list of essential medicines, pharmaceutical ingredients, and countermeasures the country would need during an emergency.
The essential medicines list was published by the FDA on October 30, following Executive Order 13944 issued in August 2020, which directed the agency to make a list identifying 223 essential medicines, medical countermeasures and 96 medical devices that are medically necessary and should always be available in the U.S., in an amount adequate to serve patient needs during emergency times.
According to an FDA press release, the list is meant to provide the agency with a framework toward building a stockpile of emergency medical supplies.
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The order focuses on supplies that would help the U.S. endure major outbreaks of emerging infectious diseases, like COVID-19, as well as during potential chemical, biological, radiological, and nuclear threats. It also focuses on establishing reliable, long-term domestic production of the medicines and products the FDA identifies as essential, to minimize potential shortages in the future, and reduce dependence on foreign medical supply manufacturers.
Executive Order 13944 calls for the FDA to coordinate on strategies for acquiring the products on the list, accelerate domestic manufacturing, and identify and address supply chain vulnerabilities. The agency must also focus on adopting innovative technologies, like advanced manufacturing techniques, which may help domestic pharmaceutical manufacturing to be more competitive with foreign countries and help keep the supply stable.
The listed medicines are divided into several key categories, such as gastrointestinal agents, anticoagulants, heart drugs, medications to combat pandemics, such as antiviral and antimicrobial drugs, and burn and blast injury drugs, among many others. The list provides some notations as to why a particular drug is critical, and the recommended dosage form.
It also includes diagnostic testing kits and supplies for rapid test diagnosis and processing, personal protective equipment (PPE), active vital sign monitoring devices, ingredients and devices for vaccine delivery, and devices for management of acute illnesses such as ventilators.
“Generally, the essential medicines we identified are those that are most needed for patients in U.S. acute care medical facilities, which specialize in short-term treatment for severe injuries or illnesses, and urgent medical conditions,” according to the FDA press release. “The medical countermeasures we identified are FDA-regulated products (biologics, drugs, devices) that meet the definition of a ‘medical countermeasure’ provided in the executive order and that we anticipate will be needed to respond to future pandemics, epidemics, and chemical, biological, and radiological/nuclear threats.”
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