20 October 2016 - Any company that plans to mimic the approach taken by Sarepta Therapeutics to win regulatory approval of a drug should think twice. 

That was the blunt message delivered on Tuesday by a high-ranking US FDA official in the wake of simmering controversy over a recent decision to approve a Sarepta drug for Duchenne muscular dystrophy, a rare and fatal disease.

The approval last month was seen as a litmus test for agency approval of new medicines, notably for diseases with unmet medical needs, as parents and lawmakers pressed the FDA to greenlight the drug. The episode was marked by unusual bickering inside the agency over clinical trial data and, moreover, is now prompting vociferous debate over whether the FDA lowered its approval standards.

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