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US FDA Gets Out Of The 'Competition' Business – At Least In Oncology

 
• By Michael McCaughan

The US FDA often reminds advisory committees that price is not part of its mission, but the agency pointedly told the experts meeting to review Lilly/Innovent’s sintilimab that “competition” should not be a factor either. Do they really mean that?

competition
Did the FDA reveal a new policy when staff said competition would not be considered in the review of Lilly/Innovent’s sintilimab? • Source: Alamy

The 10 February US Food and Drug Administration advisory committee review of Eli Lilly and Company/Innovent Biologics, Inc.’s sintilimab kicked off with an unusually lengthy set of introductory remarks by Division of Oncology Products 2 Director Harpreet Singh, intended in part to underscore the unusual nature of the meeting.

“Today’s ODAC will not follow the traditional paradigm of assessing the benefit/risk profile of a single drug,” Singh told the Oncologic Drugs Advisory Committee

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