STAT+: Pharmalittle: FDA cites another troubled plant at company contributing to cancer drug shortages; USDA to push food producers over antibiotic claims
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we plan to manicure the grounds, promenade with the official mascots and check in on the Pharmalot ancestors. And if time permits, there may be another listening party, where the rotation may include this, this, this, and this. And what about you? Summer is just days away, so why not get a head start and enjoy an outdoor activity? The list of possibilities is endless — you could stroll city streets, take a walk in the park, kick sand at the beach or traipse through the woods. Or perhaps a long night out is in order. If you remain undecided, you can always stare at the telly and seek inspiration. And remember, if dad is still around, say hi. Whatever you do, have a grand time. But be safe. Enjoy, and see you soon…
The U.S. Food and Drug Administration discovered another troubled plant run by Intas Pharmaceuticals, a generic drugmaker whose quality issues have caused one of the worst shortages of cancer medicines in decades, Bloomberg News reports. Intas makes more than 100 generic drugs approved in the U.S. and has three production facilities in Ahmedabad, India. One facility shut down after the FDA found shredded documents about quality, indicating serious lapses and raising doubts about safety and efficacy of its drugs. FDA inspectors visited another plant in May and found problems with “safety, efficacy, purity and overall quality of drug products manufactured” at the facility.
The U.S. Department of Agriculture is launching a program to ensure food producers substantiate claims that their animals are not raised on antibiotics, a move that reflects ongoing concerns that unnecessary use of these medicines causes resistance among humans, STAT writes. The agency will conduct a sampling project to assess antibiotic residues in cattle destined for the “raised without antibiotics” market. And the USDA will also issue new guidelines that recommend companies strengthen their documentation for substantiating claims that their meat and poultry product were, in fact, raised without antibiotics.
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