August 27, 2020

Senator Warren Questions How the FDA Communicates Emergency Use Authorization Changes to Health Care Practitioners and the Public

Text of letter (PDF)

Washington, D.C. - United States Senator Elizabeth Warren (D-MA) sent a letter to the U.S. Food and Drug Administration (FDA) to inquire about the process for communicating changes in Emergency Use Authorizations (EUAs) to medical providers in the field. 

Under the Federal Food, Drug and Cosmetic Act, the FDA Commissioner may issue EUAs, which allow the use of unapproved medical products or unapproved use of approved medical products in an emergency. Since February 4, 2020, the FDA has authorized at least 270 products for emergency use, including 20 types of Personal Protective Equipment (PPE) and related devices. This is a drastic and unprecedented expansion of EUAs; in total only 77 EUAs  were issued between 2005 and 2018. 

Due to supply chain disruptions and shortages of essential medical products, health care providers continue to rely on products approved under EUAs to protect themselves and their patients. The emergency authorizations for these products are typically based on limited evidence of safety and efficacy and may not satisfy the FDA’s non-emergency pre-market review standards. To date, the FDA has revoked or modified several EUAs because of new information including stating that imported, non-National Institute for Occupational Safety and Health (NIOSH)-approved, disposable filtering facepiece respirators (FFRs) cannot be safely decontaminated and reused. 

“My office has heard from some Massachusetts providers who are still using respirator masks designed for single use for up to five shifts at a time; under these circumstances, it is essential that health care organizations have clear information about which types of masks are safe for reuse,” the Senator wrote. “Yet some Massachusetts providers have expressed concern about the safety of decontaminating and reusing certain respirator masks and other forms of PPE.”

Changes and revocations of EUAs have the potential to create confusion in the field if they are not clearly communicated to providers and the public. To address these concerns, Senator Warren has asked the FDA to answer a series of questions about how the agency communicates changes to EUA approvals to providers and the public.  

In May, Senator Warren and Senator Patty Murray (D-Wash.) sent a letter to the FDA asking how the FDA tracks and analyzes adverse events, outcomes data, and product quality issues for products authorized under EUAs to ensure that benefits outweigh their risks. The senators have yet to receive a response to their May 6 letter. 

Since the beginning of the COVID-19 outbreak, Senator Warren has pressed the Trump Administration to deliver the robust set of resources needed to address this emergency, including access to PPE for Massachusetts' essential workers. She urged the Trump Administration to take swift, specific action to support Massachusetts by providing personal protective equipment, expanding testing, providing supplemental funding and supporting wraparound services as the Commonwealth combats the spread of the coronavirus disease. She has consistently sounded the alarm over the Trump administration's failure to deliver federal support for testing and care in Massachusetts, and has repeatedly called on Congress to force the Trump Administration to fully use the Defense Production Act to produce badly-needed medical supplies, including ventilators. Senator Warren also called on President Trump to ramp up efforts to publicly manufacture COVID-19 medical products, repeatedly pressed the Trump Administration to use the Defense Production Act and publicly manufacture medical supplies, and investigated "Project Air Bridge," the Trump administration's opaque medical supply chain management after multiple reports of seizures of supplies by federal officials, political favoritism, cronyism, and price-gouging via third-party sellers.