The Pink Sheet –
In this article, The Pink Sheet covers the opening day of the JP Morgan Healthcare conference and notes comments by Catalyst’s President on the impact of new leadership under Commissioner Scott Gottlieb at FDA.
During a panel at a the concurrently held Biotech Showcase, “Nancy Bradish Myers, president and founder of Catalyst Healthcare Consulting, Inc., said that one of the biggest changes happening at the FDA now is that from the top there is an ‘encouragement to the reviewers and others to be a little bit more forward thinking about new technologies and using that flexibility in new and novel ways.’”
“The current leadership is encouraging everyone to be more creative in their approaches, as if a message has come from on high: ‘let’s try it.’ I think it’s a time for people to be more creative than they have been in the past,” said Bradish Myers, an attorney and former special assistant and senior strategic advisor in FDA’s Office of the Commissioner. She warned that if companies don’t try to be more creative, then FDA can’t be creative in response.”
“There’s a lot of ‘hey come in and talk to us.’ It may not be every reviewer or every division that really wants to exercise that flexibility to the max, but there are groups that are because they are focused on the patient and what the patient really needs, Bradish Myers said.”