How Pharma is Adjusting Strategies for Changing Dynamics at 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 are pharma companies adjusting strategies for changing FDA dynamics?
David Crean: FDA is certainly moving very fast. They want to move fast AND harder on some of the assets that it likes, while slowing down certain areas that they don't like. And so, the variance has gone up.

The issue is with predictability. You see so many changes going on at the agency, whether that's at Cedar or CBER. What biotech is having to think about the need to adjust regulatory strategies in response to either the staffing changes, uncertainty, or even delays at FDA.

Companies are pushing for written confirmation of their type B, type C, or special protocol assessment outcomes. You got to get this verbal alignment, and that's certainly very important.

Also, on the on the investor sponsor side, organizations are building redundancy. They're going to Europe or Asia Pacific to have backup plans, because if there's any US pathway slip that that creates more deals or uncertainty.

Lastly, looking at deal structures, whether that's with investors or partnering, you're seeing some more contingent value rights being baked into deal structures.