June 15,2020

Press Contact:

Taylor Harvey (202)224-4515

Wyden Statement on FDA Decision to Withdraw EUA on Hydroxychloroquine

Senate Finance Committee Ranking Member Ron Wyden, D-Ore., today issued a statement after the Food & Drug Administration (FDA) announced it is withdrawing its emergency use authorization for hydroxychloroquine and chloroquine, drugs that Donald Trump has touted as a prevention and treatment for COVID-19 without medical evidence:

“The FDA withdrew an emergency use authorization that never should have been issued in the first place. By ignoring science and caving to political pressure from the White House, the FDA stoked false hope and put American lives in danger, while damaging the agency’s reputation in the process. The Government Accountability Office testified this month that it plans to examine the FDA’s issuance of emergency use authorizations, and the case of hydroxychloroquine should be front and center in that inquiry.”

On March 28, the FDA issued an Emergency Use Authorization (EUA) allowing the Strategic National Stockpile (SNS) to distribute chloroquine phosphate that was not approved by FDA to treat any disease, and hydroxychloroquine, for COVID-19 treatment. The EUA also waived requirements for Good Manufacturing Practices (GMP) that are typically applicable to the manufacture, processing, packing or holding of drugs. 

The EUA authorized receipt of hydroxychloroquine from Bayer originating from manufacturing facilities in Pakistan that reportedly had not been inspected by the FDA. A second company manufacturer, IPCA Laboratories Ltd., reportedly planned to donate 50 million tabs to the United States despite being on the FDA Import Alert list since 2015. It remains unclear how—or if—these supplies will be tracked within the U.S. drug distribution system.