Documents show minimal data supported FDA’s authorization of malaria drugs for COVID-19

FDA’s Emergency Use Authorization for chloroquine and hydroxychloroquine was based on “minimal data,” an agency review document released as result of a Freedom of Information Act lawsuit filed by BuzzFeed News indicates. The review is the most complete official documentation of FDA’s decision to grant an EUA. It does not address allegations of political pressure raised by former BARDA Director Rick Bright (see “Hydroxychloroquine Testing Hahn’s, FDA’s Independence”).

The review emphasizes the need for controlled trials and spells out the known and suspected risks posed by the drugs. It does not indicate how or why FDA determined that the potential benefits outweigh the known risks. ...