Scott Lassman: Changes to the FDA Under Scott Gottlieb, MD
Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, describes how the FDA has changed under its current leadership.
Transcript:
Can you comment on how the FDA has changed under new leadership by Commissioner Scott Gottlieb, MD?
The FDA is like a big freighter ship: it doesn’t change really quickly. That being said, I actually have seen a number of changes, or what I perceive to be changes, which is that he’s not shying away from some of the most controversial issues. I thought it was telling that Dr. Gottlieb jumped right in and said that FDA has a role in drug pricing. This was something that the FDA has shied away from for years. While Dr. Gottlieb was clear that the FDA does not have a direct role, he did say they have an indirect role, and is trying to take action to actually speed up the approval of generic drugs and biosimilars. I think he actually has been doing that, if you look at some of the recent approvals for very complex generic products (almost, one would say biosimilar-like), that had been sitting at the FDA for a long time, they’re taking action to actually move those products forward and get them in the market. He seems to be—what I would say is the big issue—he’s not shying away from the controversial issues. He’s stepping right in, and they seem to be taking a lot bolder action and taking it a lot more quickly than I would have expected.
