Biosimilar Pathway Would Disappear If ACA Repealed, Gottlieb Says
Asked during Senate hearing whether the 351(k) pathway would be repealed along with the rest of the ACA under a pending lawsuit, the outgoing commissioner acknowledged that it would, but said he hoped Congress would create it again.
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The latest drug development news and highlights from our US FDA Performance Tracker.
In congressional testimony, outgoing Commissioner Scott Gottlieb says FDA already has "a lot of applications in-house" and robust interest when asked about the 2020 transition of insulin from regulation as a drug to a biologic.
Amid all the praise for his raising of FDA's profile and aggressive policy stances, Scott Gottlieb's most valuable contribution while in office may have been leaving the agency fundamentally unchanged, an important lesson for incoming Acting Commissioner Norman Sharpless.