The F.D.A. withdrew emergency approval for malaria drugs promoted by Trump.
The Food and Drug Administration said Monday that it was
revoking emergency authorization of two malaria drugs to treat Covid-19, saying that they are “unlikely to be effective.”
The drugs,
hydroxychloroquine and a related drug, chloroquine, were heavily promoted by President Trump after a handful of small, poorly controlled studies showed that they could work in treating the disease.
Mr. Trump even took hydroxychloroquine after he was exposed to two people who had tested positive for the coronavirus. The agency said that after reviewing some data, it had determined that the drugs, particularly hydroxychloroquine, did not demonstrate benefits that outweighed their risks. Earlier this year, the F.D.A. issued a warning that the drugs could cause alarming heart arrhythmias.
In March, the F.D.A. authorized stockpiles of the drugs to be used in hospitals to treat patients with the virus. But in a letter Monday revoking the authorization, the agency said that further studies have shown that the two drugs were unlikely to be effective in stopping the virus, and that current national treatment guidelines don’t recommend using them outside of clinical trials.
According to the letter, written by Denise M. Hinton, the F.D.A.’s chief scientist, the request to revoke the authorization came from the Biomedical Advanced Research and Development Authority, a unit of the Department of Health and Human Services that is in charge of supplying treatments in public health emergencies.
Members of Congress
have questioned increases in the F.D.A.’s granting of emergency use authorizations during the pandemic for certain drugs as potential treatments. They have also questioned authorizations for antibody and diagnostic tests whose data had not been thoroughly vetted before approval, and for certain types of masks and other devices. Some Democratic lawmakers have criticized the Trump administration for pressuring the agency into issuing too many emergency approvals.