Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was featured in Medtech Insight, in the Q&A, “Interview: Putting the Pieces Together for Combo Products Oversight,” by David Filmore. (Read the full version – subscription required).
Following is an excerpt:
Bradley Thompson has been shepherding the Combination Products Coalition for more than a decade. He says the recent spotlight from FDA and other policymakers put on the combo-products space, including in a recent user-fee deal, is a welcome development after a period of neglect. Thompson spoke to Medtech Insight about the numerous reforms in the works and the state of the sector. …
Medtech Insight: I was going to say, it seems like a pretty vibrant time. And it seems that most of the attention is pushing in a positive direction for combination products. Is that your view?
Thompson: Yeah, I think so. Going back to earlier in the year when [Robert] Califf became commissioner and really took over the reins, I think combination products is an area of special focus for him, personally. I think he’s seen in practice at Duke and other places that we may be pushing some of the limits of devices alone or drugs alone, but when you start combining those modalities, all sorts of advancements become possible. I think Califf is personally excited by combination products.
From someone who hasn’t spent a lot of time with the agency, I think when he arrived, his impression – I don’t want to speak for him, but this is just my sense of it – his impression was the agency is pretty siloed. We’ve got these drug people doing their thing and the device people doing their thing and treating them as though they’re completely separate areas, when if you’re interested in cancer, you don’t look at it with blinders on. You don’t look at it as just a drug issue or a device issue. You think about what’s the best therapeutic intervention to help people with cancer.
Friends of Cancer Research and others have been encouraging him to look at ways to tear down the silos within FDA and get folks to collaborate more across the centers. I think it’s a real passionate area for him. That’s a real healthy thing. Honestly, silos don’t do anyone any good. That sort of broader thinking is very refreshing.
