The FDA dropped its quality-control standards too far as it scoured the world for scarce supplies of Trump approved chloroquine drugs, according to sources, who spoke on condition of anonymity
FILE PHOTO: A bridge is decorated with the logo of a Bayer AG, a German pharmaceutical and chemical maker in Wuppertal, Germany August 9, 2019. REUTERS/Wolfgang Rattay
The plants that make Resochin ingredients and finished doses in India and Pakistan have never been registered with, or inspected by, the FDA, according to the three government sources, as well as FDA documents compiled in the private online database FDAzilla.com. Some chloroquine drugs were already approved by the FDA before the pandemic as antimalarial medications, a process that required plant inspections. Resochin was not approved.
In a statement to Reuters, Bayer said that the FDA had tested Resochin “and found it to be of appropriate quality for release to the for emergency use. We are proud to make this donation to the U.S. government in the fight against COVID-19.” The statements came as the administration was being hammered for its slow response to the growing coronavirus crisis, which to date has infected more than 637,000 people in the United States, killing almost 31,000. His comments set high public expectations for the drugs, which are now being snapped up all over the globe.
Lenihan of the FDA told the group of health officials that “if it is the product we think it is and it is not toxic we will release it to ASPR” - the Assistant Secretary for Preparedness and Response, a division within HHS. A whistleblower complaint led to the discovery of more than 21 million Resochin tablets that were too weak, more than 12% under the specified weight of 400 milligrams, according to the Pakistani regulatory records.
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