FDA Identifies “Essential Medicines” for U.S.

The previous White House administration enacted an executive order on August 6, 2020 instructing the FDA to curate an “essential medicines list” within 30 days. This order’s intent is to reduce the United States’ reliance on the global pharmaceutical supply and minimize the chance of a shortage for critical drugs. The FDA will work with major pharmaceutical suppliers to ensure that the United States can meet a minimum supply of these essential medications, as well as identify vulnerabilities in the pharmaceutical supply chain. Per the FDA, the goal of this campaign is to ensure that the American public is protected against foreign chemical, biological, radiological, and nuclear threats, as well as emerging infectious diseases.

After the executive order was put in place, the FDA developed a list of 227 drugs and biologic products deemed “essential”, focusing on those in the acute care setting. The FDA also added 96 medical devices to the list. These devices include vital monitoring devices, devices for managing acute diseases (such as ventilators), personal protective equipment, diagnostic testing kits, and other developmental supplies. The FDA followed a general guideline of including medicines that are commonly used for U.S. patients in acute care facilities and other urgent medical emergencies. The list focuses on medicines that must be available in adequate supply that can be used for the widest patient populations to have the largest potential impact on public health.

Once the FDA identified the medications and medical devices on the “essential medicines list”, the next action was to coordinate strategic plans to acquire supplies of these items. The government followed plans to accelerate domestic manufacturing of these items and address supply chain issues that could occur under extreme domestic or foreign uncertainty. A $354 million 4-year deal was struck with the Biomedical Advanced Research and Development Authority (BARDA) to immediately resolve the current drug shortages.  The deal also has an option to extend this into a $812 million 10-year deal to maintain supplies.  Many legislators have cited the United States’ dependence on outsourced medical supplies and the need to make these products domestically. Further legislative action is currently being discussed on Capitol Hill by members of both parties. A $500 million pilot program is currently in progress to support domestic production of medical supplies.

The United States’ reliance on foreign goods often allows Americans to get supplies far cheaper than if they were manufactured domestically. The main fear comes in times of uncertainty or diplomatic friction, as this may cause foreign countries to supply themselves with medical supplies and pharmaceutical drugs before selling to the United States. The United States has taken steps over the recent months towards creating a surplus of essential medications and devices. These simple actions will protect the health and longevity of the American public, even during times of crisis.

 

Posted: March 2021

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