Senator Baldwin to Trump Administration: We Need Answers Now on Oversight and Distribution of Hydroxychloroquine

WASHINGTON, D.C. – Today, U.S. Senator Tammy Baldwin is raising questions with the Federal Emergency Management Agency (FEMA) and the Assistant Secretary for Preparedness and Response (ASPR) about their oversight and distribution of hydroxychloroquine, including the distributions made to states and cities from the Strategic National Stockpile (SNS).

On April 14, 2020, FEMA confirmed that the SNS sent out 19.1 million tablets of hydroxychloroquine to cities around the country to be distributed and used for patients with COVID-19. Hydroxychloroquine is approved by the Food and Drug Administration (FDA) for the prevention and treatment of malaria, as well as certain autoimmune conditions such as lupus and rheumatoid arthritis. It is not, however, approved for the treatment of COVID-19. While no FDA-approved treatment for COVID-19 exists, President Trump has promoted the drug as a potential treatment for COVID-19 to the American public. This is despite mounting scientific evidence that hydroxychloroquine may cause serious side effects in patients with COVID-19, and in some cases, increase their risk of death.

On March 28, 2020, the FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the SNS to be distributed and used for patients with COVID-19 in limited treatment and experimental trial settings. Recently released documents indicate that the FDA used extremely limited scientific evidence to inform the use of a EUA. In addition, a whistleblower complaint filed by Dr. Rick Bright, who was removed from his position as director of HHS’ Biomedical Advanced Research and Development Authority (BARDA) and Deputy Assistant Secretary for Preparedness and Response, describes a number of Administration officials taking questionable action to promote hydroxychloroquine beyond and in violation of the FDA’s EUA. In his complaint, Dr. Bright alleges that FEMA Administrator Peter Gaynor received instructions from FDA Commissioner Dr. Stephen Hahn to distribute hydroxychloroquine to pharmacies nationwide, despite the clear authorization in the EUA for use of the drug only in hospital settings.

In her letter to FEMA Administrator Gaynor and Assistant Secretary for Preparedness and Response Secretary Kadlec, Senator Baldwin writes:

“I am alarmed by this pattern of efforts to cast aside scientific evidence and appropriate agency oversight in order to appease the whims of the White House. Furthermore, I am concerned by a lack of accountability from both ASPR and FEMA, which have claimed to have little insight into the distribution of hydroxychloroquine. This, despite the fact that the supply was obtained and stored in the SNS managed by ASPR, and distributed to states and cities by FEMA as part of the Administration’s response to the COVID-19 pandemic. Willful ignorance is either an intentional effort to evade oversight, or demonstrative of widespread incompetence. Both are unacceptable as our country continues to face a public health crisis.”

In her letter, Baldwin is requesting answers from FEMA and ASPR to the following questions:

1. How many tablets of hydroxychloroquine and chloroquine phosphate remain in the Strategic National Stockpile (SNS)? Does ASPR intend to replenish these supplies?  If so, will ASPR and other federal agencies again attempt to secure donations from private companies? 
2. What evidence-based analysis has ASPR conducted to determine if a supply of hydroxychloroquine and chloroquine phosphate for hospitalized patients with COVID-19 is needed in the SNS? If ASPR has determined that a supply of hydroxychloroquine and chloroquine phosphate is needed, how did it determine what amounts are appropriate to include in the SNS?
3. How did FEMA determine which cities and states would receive shipments of hydroxychloroquine? Was it based on an analysis of COVID-19 hotspots or was this in response to requests from states, localities, health systems or individuals?
4. Did FEMA prioritize shipments of hydroxychloroquine over other supplies requested by states, including requests for personal protective equipment (PPE) and ventilators?
5. FEMA has indicated that pharmacies and care sites also received shipments of hydroxychloroquine, despite the fact that the FDA’s EUA is limited to patients hospitalized with COVID-19. How is FEMA working to ensure that shipments of hydroxychloroquine are used for purposes outlined in the FDA’s EUA or for conditions for which the drug is an approved treatment?

Senator Baldwin has previously requested that the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) launch an investigation into the Trump administration’s promotion of hydroxychloroquine as a treatment for COVID-19, despite the fact that it is not a FDA-approved treatment for the coronavirus. Last week, she wrote to FDA raising questions about their regulation and oversight of hydroxychloroquine, including FDA’s Emergency Use Authorization.

The full letter is available here.