Amicus CEO lobbied FDA to reverse FDA’s rejection of migalastat, claiming a delay of up to 7 years
Handwritten Note from John Crowley to Scott Gottlieb.
Five days after Scott Gottlieb was sworn in as head of the FDA last May, Amicus $FOLD CEO John Crowley was personally lobbying him to reverse a stinging rejection of migalastat, his new drug for rare cases of Fabry disease.
He overnighted a letter — obtained by the Project on Government Oversight — to Gottlieb explaining that the company had determined that it would take an extraordinary 5 to 7 years to complete a Phase III study of gastrointestinal symptoms that the agency had determined would be required before it could consider offering a green light for marketing. That would not be feasible in a reasonable amount of time, he said. And he reviewed new data that had been shared with CDER director Janet Woodcock, the FDA’s Julie Beitz and others at her request.
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