Pentagon pilot for independent lab generic drug testing--FDA tries to get in the way
The Pentagon recently started a pilot project with a private independent lab Valisure to test generics. In that study, Valisure found a drug given to soldiers who had lost limbs not only didn't contain enough active ingredient to be effective, but it contained impurities that could cause kidney failure and seizures. From the article:
One morning in October, US Army Colonel Victor Suarez finished his usual morning workout — a 32-mile bike ride — and then sat down in his home office in Frederick, Maryland. When he opened his email, his stomach dropped.
Suarez spent his career getting medicines to military hospitals and combat troops, including those in Iraq and Afghanistan. He had recently sought out an independent lab to assess the quality of those drugs, in large part because he doubted the US Food and Drug Administration’s ability to police a supply chain now dominated by low-cost manufacturers in India and China. His inbox offered a glimpse of the first batch of test results.
They revealed that some generic versions of one important drug, given to soldiers who’ve lost limbs in combat, might not work. They could even cause kidney failure and seizures. The idea that already-wounded personnel might be facing an even more difficult recovery — all to save a dollar or two a pill — gutted Suarez. “Oh my God, what are we doing here?” he recalled thinking.
Still more infuriating was that doctors had long warned the FDA that some versions of the drug performed poorly. Known by the chemical name tacrolimus, it’s typically prescribed to organ-transplant patients. The lab Suarez engaged had started testing samples in early September. One of the generics assessed as problematic is manufactured in India by Intas Pharmaceuticals Ltd. It was only a couple of weeks later that the FDA announced, after more than a decade of study, that the Intas version wasn’t equivalent to the brand-name drug it sought to mimic. The outside lab had taken a month to flag similar problems.
Here is a link to the entire article. Unfortunately, it requires you to put in an email to register for a free account. I used my junk email. It's worth a read.
https://www.bloomberg.com/news/features/2023-12-05/pentagon-is-skeptical-of-cheap-generic-drugs-approved-by-the-fda?accessToken=eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJzb3VyY2UiOiJTdWJzY3JpYmVyR2lmdGVkQXJ0aWNsZSIsImlhdCI6MTcwMTczNDkyMSwiZXhwIjoxNzAyMzM5NzIxLCJhcnRpY2xlSWQiOiJTNTYyTzFUMEcxS1cwMSIsImJjb25uZWN0SWQiOiIwMzc5NjQ2NkI3QkE0Q0E4QTJCMDZBMjI0NUE3ODlCNiJ9.ebdWD0MSuOg1BASMK1A2E1IxTceaLLU9huSQaXeWB7s