BioCentury
ARTICLE | Regulation

Hydroxychloroquine testing Hahn’s, FDA’s independence as countries, scientists negate use

May 27, 2020 11:56 PM UTC

FDA’s decisions on hydroxychloroquine and chloroquine for COVID-19 have become a test of FDA Commissioner Stephen Hahn’s independence from political pressure, with mounting evidence of the drugs’ lack of benefit and dangerous cardiac liability. The question is whether, or when, Hahn will reverse course to protect patients and risk publicly contradicting President Donald Trump’s public and vocal support for their use.

The agency granted Emergency Use Authorization on March 28 to hydroxychloroquine and chloroquine to be used to treat hospitalized COVID-19 patients, citing “anecdotal clinical data in case series,” as the basis. According to ousted BARDA Director Rick Bright, the EUA was issued after FDA came under extraordinary pressure from Trump, HHS Secretary Alex Azar and administration supporters to grant broad, unrestricted approval to the drugs (see “Bright Shines Harsh Light On America’s COVID-19 Preparedness, FDA’s Independence”)...