FDA Goes Below Standards to Seek Chloroquine Drugs to Fight Coronavirus
On March 21, two days after Trump first boasted chloroquine drugs as a gamechanger in the battle against COVID-19, administration officials privately described what they felt was a win in the president’s efforts to build an emergency stockpile of the drugs: a hefty donation of pills from Bayer AG.
In an exchange of enthusiastic emails amongst federal health officers, Keagan Lenihan, chief of staff of the
(FDA), warned that 3-4 days of testing could be required.
Bayer has since donated three million tablets of the drug, called Resochin, to the U.S. national stockpile for therapy of COVID-19, the disease attributable to the coronavirus. After a brief interval of testing, its use in the U.S. was approved on an emergency basis.
However, three U.S. government sources accustomed to the matter said there’s reason to be concerned in regards to the quality of Resochin and its makers, located in India and Pakistan.
Although some guidelines can be waived in an emergency, the FDA dropped its quality-control requirements too far as it scoured the world for scarce supplies of chloroquine medication, based on the sources, who spoke on condition of anonymity.
The plants that make Resochin ingredients and finished doses in India and Pakistan have never been registered with, or inspected by, the FDA, based on the three government sources, in addition to FDA documents compiled in the private online database FDAzilla.com.
Some chloroquine drugs have been already accepted by the FDA earlier than the pandemic as antimalarial medications, a process that required plant inspections. Resochin was not approved.