Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, describes how the FDA has changed under its current leadership.
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.