“Maybe the game here is industry makes a pitch for Europe to be willing to raise prices... If it doesn’t work out in a voluntary manner then it becomes more hardball, where the US government plus companies move forward on this.”
– Boston University’s Rena Contion amped up efforts by drug companies to boost drug prices in Europe that are more aligned with the US, and involving the Trump Administration to use its tools, possibly including tariffs, to pressure the EU
Find out more: Raising Drug Prices In The EU Could Take Years, Even If Pharma Effort Succeeds
“Right now, I think it’s gone very crudely, and it’s been to some degree insulting for people who are committed public servants that worked their whole life at FDA and have been told that they might be a sock puppet or something for industry.”
– Ultragenyx’s Emil Kakkison recent layoffs and other changes at the US Food and Drug Administration.
Find out more: US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says
“Anything where the EU looks for harmonization, they’re also going to be looking for greater transparency...Pharma will worry about this, especially on the CTR. It’s about, what do I have to provide? What kind of detail do I have to provide around my protocols?”
– Treehill Partners’ Mark Mayhew on the need to protect trade secrets and commercial confidentiality data under new EU laws affecting the life sciences sector.
Find out more: US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says
“We would have been happier if those specificities were translated into a written intention. I think there is a good intention, potentially a willingness to be pragmatic, but we’ll have to see.”
– Kiji Therapeutics’ Miguel Forte on the need for the European Commission to commit to improving flexibility towards joint clinical assessments conducted under the Health Technology Assessment Regulation.
Find out more: What the EMA Can Teach HTA Bodies About Joint Clinical Assessment
“As somebody who’s very committed to public health, I will stay around as long as I’m considered to be welcome to stay around because I think it’s very important that people see that there’s constant leadership here.”
– The US Food and Drug Administration’s Peter Marks on his plans during the second Trump Administration.
