Sanders snacking on Brussels Sprouts and cheese at Zaytinya. Photo: Victoria Knight/Axios
We're back again with another lunch feature, this time with Coherus BioSciences vice president of government affairs and public policy David Sanders.
- He recently sat down with Axios at Zaytinya over roasted Brussels sprouts and chicken skewers to chat about biosimilars and the drug supply chain.
- Coherus recently launched a low-cost Humira competitor. Beyond his work on biosimilars, Sanders also is executive director of Securing America's Medicines and Supply, a group of pharmaceutical companies pushing for domestic manufacturing of products.
- He previously worked at Teva, where he helped push for the creation of the biosimilars approval pathway within the Affordable Care Act, and for Sen. Marsha Blackburn when she was a House member.
Biggest challenge for biosimilars industry: The pathway that we envisioned 15 years ago is not quite the pathway that we've got today.
- Unless we make improvements to Medicare, but also to the way commercial payers and middlemen treat these low-cost alternatives, we're gonna see the [drug] development program across the U.S. industry dry up. That's the real warning right now, is that you're going to see people get out of the business.
The PBM reform legislation he's pushing: The Blackburn-Menendez PBM legislation. I think that's the core of what's going to end up being passed ... but we need to add some things to it, to make it more meaningful, such as either banning rebates for originators with competition or creating a biosimilars-only tier for the biosimilars with the lowest wholesale acquisition cost.
On addressing cancer drug shortages: I wouldn't give the FDA more authority. They have enough authority but they should increase inspections. I do think Congress should consider giving them more money for more inspections. I would add that to the framework that [Rep. Cathy McMorris Rodgers] put together.
- We're also endorsing the RAPID Reserve Act ... as well as giving construction authority to the assistant secretary for preparedness and response.
- (The RAPID Reserve Act would contract with generic drug companies in the U.S. and OECD member countries to keep certain reserves of drug supplies on hand. Construction authorities would allow for an increase of domestic manufacturing.)
Predictions for PAHPA: PAHPA is probably going to get delayed. PAHPA could be a December or March bill. So PAHPA could become a vehicle for a lot of these things [drug shortage issues] and/or the PBM reform.
Best memory of working on the Hill: I was given the distinct honor by Rep. Marsha Blackburn to write her floor speech for the day we honored the life and legacy of Johnny Cash. It meant a lot to me because I knew Johnny. I grew up with Waylon Jennings' son so I met Johnny that way.
