FDA may have dropped standards too far in hunt for chloroquine to fight coronavirus: Sources
Bayer has donated three million tablets of the drug, called Resochin, to the US national stockpile for treatment of COVID-19. After a brief period of testing, its use in the US was approved on an emergency basis
On 21st March, 2020, two days after the US President Donald Trump first touted chloroquine drugs as a “gamechanger” in the fight 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 among federal health officials reviewed by Reuters, Keagan Lenihan, Chief of Staff, US Food and Drug Administration (FDA), cautioned that “three to four days” of testing would be needed.
“Potentially serious issues with product so let’s be careful when we take that win,” she wrote.
Bayer has since donated three million tablets of the drug, called Resochin, to the US national stockpile for treatment of COVID-19. After a brief period of testing, its use in the US was approved on an emergency basis.
But three US government sources familiar with the matter told Reuters that there is reason to be concerned about the quality of Resochin and its makers, located in India and Pakistan.
Although some rules can be waived in an emergency, the FDA dropped its quality-control standards too far as it scoured the world for scarce supplies of chloroquine drugs, according to 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, 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 anti-malarial medications, a process that required plant inspections. Resochin was not approved.
Pakistani regulators, who inspected Bayer’s Resochin plant in Karachi in 2015, found a “gross failure” in manufacturing processes there, according to documents from the Drugs Regulatory Authority of Pakistan, reviewed by Reuters. And though the FDA has never screened the Indore, India, plant that supplies ingredients for Resochin, the US agency has inspected other Indian plants run by the same Indian supplier and found serious deficiencies, including falsification of records, inspection documents spanning 2014 through 2019 show.
Responding to questions from Reuters about Resochin, Michael Felberbaum, spokesman, FDA said that the agency “sampled and tested the donated drugs to evaluate acceptability for importation” and they met appropriate standards.
Asked about Lenihan’s 21st March email, , the FDA spokesman said the agency “does not comment on alleged, leaked emails.”
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 (stockpile) for emergency use. We are proud to make this donation to the US government in the fight against COVID-19.”
Resochin is part of a class of medications containing one of two active ingredients – chloroquine or hydroxychloroquine – that the Trump administration has praised as a potentially life-saving treatment. However, the effectiveness of chloroquine drugs against coronavirus has not been proven. Even though in use for years in the United States, as a treatment for malaria and autoimmune conditions like lupus, the medicines can have serious side effects, including heart arrhythmias.
The three US sources who spoke with Reuters, as well as