FDA, Sarepta and Ohio
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Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
16don MSN
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
For years, inspectors have uncovered dirty equipment, contaminated supplies and fraudulent testing records in some overseas factories — serious safety and quality breaches that can sicken or kill consumers.
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s work, current and former employees say, and the situation could become more dire as low morale pushes more workers to the exits.
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency;
Cuts at the FDA are slowing inspections of overseas drug manufacturers, prompting concerns from former and current employees that medication safety could be at risk, ProPublica reported July 7. Dozens of individuals who help coordinate the travel for complex inspections of foreign drugmaking factories have been let go,