Did US Buy Substandard Drugs For COVID-19?
Bayer AG made a hefty donation of chloroquine drugs after the President Donald Trump touted the tablet as a “gamechanger” in their fight against COVID-19. But the chief of staff of the US Food and Drug Administration, Keagan Lenihan, was found alerting the government about the need for 3-4 days of testing of the drugs.
FDA alerts the US government
Reuters reviewed the emails among federal health officials in which the FDA chief was seen alerting the administration. Bayer had since donated 3 million tablets of Resochin to add to the US stockpile of COVID-19 drugs. Also, the US government approved use of those medicines on an emergency basis. But three US government sources raised serious concerns about the quality of the drugs.
Concerns raised by US officials
The drug Resochin is made in India and Pakistan and according to the sources, the FDA dropped its quality-standards to get the drugs. But the fact is that the plants that make Resochin in India and Pakistan have never been registered or inspected by FDA.
Drugs Regulatory Authority of Pakistan noticed gross failure in manufacturing process of Resochin in a Pakistani plant in 2015. In India, Resochi is made in Indore. The US agency that inspected that plant found serious deficiencies including falsification of records during 2014 to 2019.
On questioning about the email messages by Reuters, the FDA spokesperson Michael Felberbaum said that the agency didn’t respond to the leaked emails. Also, the spokesperson said that the donated drugs met the quality standards of FDA.