• Three manufacturing plants of Ipca Laboratories get exemption
• Agency had cited ‘systematic data manipulation’ at one plant
This sounds fine, and I'm sure no Americans will be harmed. Everything is going great.
At Bloomberg News, an important story today about all the bonkers demand for chloroquine and hydroxychloroquine, two unproven drugs for coronavirus and COVID-19 that Donald Trump has decided are the cure, or something.
Trump wants large quantities of these drugs in the U.S. right away, even though nobody's sure if they do anything at all to help yet, so the U.S. is now lifting restrictions on a pharmaceutical company in India that has had factories banned from selling to America on quality concerns.
Chloroquine and hydroxychloroquine were first approved in the U.S. decades ago, and “There is no definitive evidence of their effectiveness against the novel coronavirus that has sickened over 349,000 globally and killed more than 15,000, but after Trump called the drugs a “game changer” and promised to make them more available, demand surged,” report Ari Altstedter and Anna Edney at Bloomberg News:
Mumbai-based Ipca Laboratories Ltd. said in a March 21 securities filing that the U.S. Food and Drug Administration “has made exception to the import alert” for three of its facilities, allowing it to supply tablets as well as raw materials for making chloroquine phosphate and hydroxychloroquine sulphate.
The U.S. is facing possible shortages of both drugs, which are also widely prescribed to treat rheumatoid arthritis and lupus. Hospitals have been stocking up on the treatments in recent weeks following reports from doctors outside the U.S. that they were effective against Covid-19, the disease caused by the novel coronavirus. There have been no large-scale clinical trials to support those claims.
The factories where Ipca makes the medications have been under an import alert from the U.S. regulator since 2015, after inspectors discovered multiple violations of its manufacturing guidelines, including “systemic data manipulation” in tests meant to ensure the drugs’ efficacy and safety.
Read the whole story at Bloomberg News:
FDA Lifts Import Curbs on Maker of Unproven Virus Drug in India