May 08, 2020

Senators Warren and Murray Urge FDA to Monitor Potential COVID-19 Medical Products to Ensure the Health and Safety of Americans

FDA has acted to increase the availability of possible COVID-19 treatments and other medical products and must carefully track the use of these newly authorized products to ensure their benefits outweigh their risks

Text of Letter (PDF)

Washington, DC -- United States Senator Elizabeth Warren (D-Mass.), a member of the U.S. Senate Health, Education, Labor, and Pensions Committee (HELP), and HELP Ranking Member Patty Murray (D-Wash.) sent a letter to the U.S. Food and Drug Administration (FDA), which has acted to increase the availability of possible coronavirus disease 2019 (COVID-19) treatments, diagnostic tests, and other medical products through emergency use authorizations (EUAs), asking about how the agency is tracking the use, safety, and effectiveness of these products to protect and ensure the health and safety of Americans during the COVID-19 pandemic.

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 issued 112 EUAs for COVID-19-related medical products, including tests, personal protective equipment, and ventilators. This is an unprecedented expansion of EUAs-only 77 EUAs in total were issued between 2005 and 2018. The seriousness of the COVID-19 pandemic warrants extraordinary measures, but also places the burden on FDA to carefully monitor the use of these newly-authorized products.

Serious concerns about the safety, efficacy, and quality of hydroxychloroquine sulfate and chloroquine phosphate ("hydroxychloroquine") demonstrate the importance of FDA's monitoring for health and safety outcomes of products authorized via EUA. On March 28, 2020, the FDA issued an EUA for hydroxychloroquine after President Trump reportedly "contacted Dr. Stephen Hahn, the FDA administrator, and other top health officials, questioning whether they were moving rapidly enough to make the drugs more widely available." There is limited evidence of hydroxychloroquine's effectiveness in treating COVID-19, but well-known lethal cardiac side effects. The letter also cites reports that the FDA lowered its quality-control standards so that the Administration could accept Bayer Pharmaceuticals' donation of millions of hydroxychloroquine tablets, reports that were confirmed in this week's whistleblower complaint by former BARDA Director Dr. Rick Bright, who has recently faced retaliation for raising concerns about political interference within the Trump Administration.

On May 1, 2020, the FDA issued an EUA for remdesivir to be used for the treatment of patients hospitalized with COVID-19, an antiviral drug that Dr. Anthony Fauci has said "will be the standard of care." Given that demand for remdesivir will likely be extremely high, the lawmakers urged the FDA to ensure that Gilead Sciences, the maker of remdesivir, and healthcare facilities and providers, report all adverse events and maintain all records regarding its use as required by the EUA.

"In the face of this pandemic, the FDA has an important role enabling the rapid emergency use of various drugs, biological products, and devices, including diagnostics, using data-driven, science-based decision-making processes. We urge the FDA to track and analyze adverse events, outcomes data, and product quality issues for products authorized under EUAs to ensure their benefits outweigh their risks," concluded the lawmakers.

The lawmakers have requested a response no later than May 20, 2020.