Overzealous And Interventionist Feds Come Up Short On Drug Shortages
"But the most important factors are the culture and actions of federal regulators. Drug manufacturers complain that FDA has been unpredictable and also slow to approve new facilities and manufacturing processes, exacerbating interruptions in production. Worse still, increasingly risk-averse and capricious regulation by the Obama administration’s FDA has inhibited drug development and production generally. On occasion, FDA has demanded that a new drug demonstrate superiority over existing therapies, which is above and beyond the statutory requirements for safety and efficacy."
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