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Poll: #FDA Just Blundered Badly re Approval of Duchenne Treatment

Poll: #FDA Just Blundered Badly re Approval of Duchenne Treatment | Pharma Industry Regulation | Scoop.it

There’s no doubting how to interpret these numbers. Two thirds of the people we polled felt that the FDA should not have approved Sarepta’s Exondys 51 (read “Janet Woodcock Won a Huge Power Struggle Within #FDA Over eteplirsen Approval”; http://sco.lt/72Q2hl). This was a non-partisan favorite. There was virtually no difference on which way they leaned on the presidential showdown, either. Whether they thought Trump or Clinton was better for biotech, the majority clearly felt that the agency had made a mistake.

 

Sarepta helped foment one of the biggest patient advocacy campaigns ever mounted for an approval. But several top FDA officials made it clear that the company had never successfully made its case for this drug. FDA Commissioner Robert Califf also cited the company for playing fast and loose with some of the data the company used to make its case with patients and investors. But he bowed to the decision made by CDER director Janet Woodcock. And that, says the majority, was a mistake.

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