Patrick Terry comments on latest FDA drug rejections
Scientia Advisors in the News
Boston Business Journal Quotes Patrick Terry in Tougher FDA giving local biotechs headaches
Julie M. DonnellyJanuary 21, 2011
This Boston Business Journal article reports on the increasingly risk-averse climate at the FDA which has recently rejected several drugs developed by Massachusetts-based companies, the latest one being liprotamase, the cystic fibrosis drug candidate from Alnara Pharmaceuticals.
According to Patrick Terry, Principal at Scientia Advisors, "the FDA has approved the fewest number of new drugs in the past two years, than any other time in its history. He said fear of Congressional hearings over drug safety issues has FDA staff quaking in their boots because Democratic presidential administrations have a tendency to focus extra scrutiny on the agency. Terry and other biotech consultants say their clients are responding by trying to engage the FDA earlier in the drug development process, and ask for more guidance about how the clinical trials should be designed. But companies that designed their trials years ago and are going through the approval process now, Terry said, often find the rules of the game have changed."
Read more about the unexpected drug rejections from the FDA at: Boston Business Journal
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