FDA Publishes List of Essential Medicines to Address COVID-19

FDA recently published a list of 223 essential medicines, medical countermeasures, critical inputs to have available at all times and serve patient needs in the appropriate dosage forms.

The product list includes gastrointestinal agents, anticonvulsants, antiemetics, anticoagulants, antimetabolite, chemotherapeutic, antihistamines, antivirals, steroids, and vaccines.

Additionally, 96 device medical countermeasures were included on the list, such as diagnostic testing kits and supplies for rapid test development, personal protective equipment, active vital sign monitoring devices, devices for vaccine delivery, and devices for acute illnesses.

FDA stated that its goal is to ensure the American public is protected against outbreaks of emerging infectious diseases, such as the coronavirus, as well as chemical, biological, radiological, and nuclear threats.

“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,” an FDA spokesperson stated in the announcement.

“When identifying essential medicines and medical countermeasures, we focused on including those that are medically necessary to have available in adequate supply which can be used for the widest populations to have the greatest potential impact on public health.”

An August executive order signed by President Trump directed FDA to identify a list of products and inputs that are medically necessary to have available 24/7 to serve patient needs and in the right dosage forms.

Essentially, the executive order directed FDA to identify supply chain vulnerabilities, target counterfeit drug and medical supply imports, and coordinate with federal partners on various issues.

Other government agencies, including HHS, the Department of Defense, and Veterans Affairs, were also directed to purchase essential drug and medical supplies solely from American manufacturers.

Overall, the executive order aimed to boost domestic manufacturing and supply chains for pharmaceutical and medical supplies, to combat any potential shortages and reduce the US’ dependence on foreign manufacturers of these products.

The order would also support American jobs by ensuring long-term demand for those products as well, the President stated.

“We believe that the adoption of innovative technologies, such as advanced manufacturing techniques could enable U.S.-based pharmaceutical manufacturing to bolster its competitiveness with foreign countries and help ensure a stable supply of drugs critical to the health of U.S. patients,” FDA said in the October announcement.

The COVID-19 pandemic has caused a significant increase in the number of hospitalized patients, which has created a shortage of supplies and critical medicines.

Back in March, pharmaceutical company Vizient announced that it released recommendations to the White House Coronavirus Task Force and FDA to improve access to two of its essential COVID-19 drugs.

The recommendations focused on redirecting the supply of the drugs from retail pharmacy settings to hospital/ acute care environments where severely ill patients are being cared for.

Specifically, over a period of a week, Vizient noted that it had seen a 6,842 percent and 2,196 percent increase in orders by Vizient members for chloroquine and hydroxychloroquine, respectively, just weeks after the World Health Organization declared COVID-19 a pandemic.

And two months later, HHS expanded pharmaceutical manufacturing in the US to produce medicine needed during the pandemic and increase capacity for producing finished generic drugs.

HHS stated that it will work with a team of private industry partners to rapidly develop a list of active pharmaceutical ingredients and finished medicines critically needed during COVID-19.

The four-year $354 million agreement with BARDA, part of HHS, will allow HHS to immediately respond to COVID-19, which will help decrease or prevent drug shortages during the pandemic. 

Notably, the contract can be extended up to $812 million over ten years to maintain systems and supplies.