FDA Identifies “Essential Medicines” for U.S.

As part of the administration’s campaign to reduce U.S. reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies. The list will provide a basis for bolstering biopharmaceutical production at home of essential medicines and medical products and for addressing supply chain vulnerabilities.

The White House launched this process with an executive order issued August 6, 2020 instructing FDA to develop the essential medicines list in 30 days. The resulting list includes 233 drug and biological products and active pharmaceutical ingredients (APIs) for treatments able to protect against emerging infectious diseases plus chemical, biological, radiological and nuclear threats. An additional list covers 96 important medical devices such as diagnostic testing kits, personal protective equipment, monitoring devices, ventilators, and items for vaccine delivery. The listed products are identified as those most needed for treating patients in acute care medical facilities and for responding to future pandemics and biomedical threats.

To bolster purchases of U.S.-made drugs, the program also calls for federal agencies that fund health care programs to favor domestic sources in purchasing essential medicines. FDA is coordinating government-wide efforts to acquire listed products, identify supply chain vulnerabilities for these products, and to support advanced manufacturing and innovative technologies likely to bolster the competitiveness of U.S.-based manufacturing compared to foreign countries. The August executive order also calls for FDA to accelerate the approved of U.S.-made essential medicines and to refuse entry into the U.S. of products from foreign plants that have blocked FDA inspections. Moreover, the administration looks to streamline environmental and other regulations likely to curb domestic biopharma production.

FDA seeks comments from manufacturers and other stakeholders on the criteria it used to develop the essential medicines list, on additional medicines and products to include on the list, and on how often the list should be reevaluated. It’s general criteria for listing essential medicines includes both acute-care treatments and those needed for longer-term health management, with a preference for dosage forms most commonly needed in acute care facilities. Where multiple drugs might be available, FDA looks for treatments for the widest population, for multiple conditions, and those with unique safety profiles.

Legislating further policy changes

Concerns that ongoing vulnerabilities in the U.S. medical supply chain may compromise public access to essential medicines continues to draw attention on Capitol Hill, generating calls for legislative action after the elections. Members of Congress from both parties support a range of initiatives to reduce U.S. dependence on foreign manufacturers, including a $500 million pilot program to support domestic production of medical products. At a recent program on ensuring a “responsive Rx supply chain,” Rep. Elissa Slotkin (D-Mich) discussed a package of bills supporting Buy American requirements for medical supplies and pharmaceuticals. Similarly, Rep. Buddy Carter (R-Ga) cited how the COVID-19 crisis has highlighted the nation’s dependence on outsourced goods and the need for legislation to support U.S. production of APIs, drugs and excipients.

The legislators cited over-dependence on China for protective equipment and other medical supplies and fears that manufacturers in foreign countries will look to supply their own market before supporting exports to the U.S.. Rep. Carter wants to build state medical product stockpiles to reduce dependency on national stockpiles and to provide sufficient support to attractive private biopharma companies back to the U.S.