The Industry’s Communication and Engagement with FDA

Marty Makary is the latest key leader at HHS to leave their role over the past two years. Aside from the coming and going of important roles, the current administration also has plans to majorly overhaul FDA and the drug approval process.

As a result, the industry is struggling to keep up with the changes. Under Makary’s leadership, a number of surprising CRLs were issued. While biotech companies attempt to adjust their strategies, investors are also changing their view of the industry.

David Crean, chief business officer at MedicNova, recently spoke with Pharmaceutical Executive about the industry’s attempts to improve communication and coordination with FDA. He also addressed the issues investors are paying attention to, which are primarily related to seeking greater regulatory certainty.

Pharmaceutical Executive: How would the industry rate FDA communication and engagement?
David Crean: I would say it's very mixed. I think their ideas going forward are well intended, but it's they're poorly executed, if you will. It's tough when you start eliminating a lot of people, a lot of institutional knowledge at the agency, whether it's at Cedar or CBER or even CDRH and other health and human service organizations.

From the industry perspective, what I see as an operator is that we're really trying to get a better handle on communication and getting in earlier. For example, if I was an early stage biotech company, I'd be utilizing free INDs and earlier communications with FDA to try and get regulatory commitment and guidance. I’d do this as opposed to waiting until later on, like a phase two, when you start to go to them and get hit with a surprise.

Well, here's what you should have known, that before you got to a phase two, you should really do it much earlier. We're trying to establish better and better communication with the agency.