FDA pulls emergency approval for antimalarial drugs touted by Trump as covid-19 treatment

Critics credited the agency for changing course but said the initial decision 'put political expediency ahead of scientific expertise.’

The Food and Drug Administration withdrew its emergency use authorization for hydroxychloroquine and chloroquine, drugs that President Trump repeatedly promoted for treatment of covid-19, reversing a decision that led to harsh criticism it had put politics ahead of science.

The FDA said Monday the medications “were unlikely to be effective” for covid-19 and that any potential benefits were outweighed by safety risks, including heart problems. The decision was outlined in a letter from Denise Hinton, the agency’s chief scientist, to Gary Disbrow, the acting director of the Biomedical Advanced Research and Development Authority, who requested the revocation. The FDA said the change was prompted by new information, including clinical trial results.

The FDA had authorized the antimalarial drugs in late March for hospitalized covid-19 patients after small studies indicated they might provide a benefit. But the decision quickly became a scientific flash point, with critics, including former FDA officials, calling the evidence scant and accusing the agency of buckling to political pressure from the White House. Several argued that what was at stake was larger than just the emergency approvals, in terms of the public’s ability to trust the federal response to the pandemic was based on the best available evidence.

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