Did the FDA break its own rules in approving the antibiotic Recarbrio?

Since the 1960s, in the wake of the thalidomide tragedy, the US has required drug makers to provide “substantial evidence” that drugs are effective. This evidence, says the law, must consist of “adequate and well-controlled investigations.”Today there is evidence that these standards are being bypassed. This concern is illustrated by the recent approval of the new antibiotic Recarbrio, a drug over which the US Food and Drug Administration had serious doubts. Despite the absence of any clinical studies to provide substantial evidence of its effectiveness the agency approved the drug, a product 40 times more expensive than an existing generic alternative. Did the FDA break its own rules in approving this antibiotic, and what does this case tell us about problems within the agency?Recarbrio was approved back in July 2019. A Merck drug, it is a three drug combination injectable antibiotic adding relebactam, a new β-lactamase inhibitor drug to imipenem…
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