FDA 2017 Year In Review: Therapeutic Products Energized By Cures Act, Bold Leadership

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For those of us who monitor the Food and Drug Administration (FDA or the Agency) and counsel FDA-regulated entities, it has certainly been a whirlwind of a year.

2017 began with no clear picture of who would be assuming leadership of the Agency, but also with a brand-new piece of critically important (and bipartisan!) legislation - the 21st Century Cures Act (see our prior posts here) - which imposed new obligations and authorities on FDA that needed to be implemented, operationalized, and fully funded. In early May, Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of FDA and he moved quickly to shift policy priorities in almost every area that the Agency regulates, a goal that in some ways was made more efficient due to the concurrent timing of modernization mandates imposed by the Cures Act. This year's must-pass User Fee Act, the FDA Reauthorization Act or "FDARA" (see our prior posts here) engendered some hand-wringing and political drama over the summer, but was ultimately passed by Congress in August and signed into law. FDARA includes some important policy and programmatic changes for new prescription drugs/biologics, generic drugs, and biosimilars, but it did not contain major wholesale reforms to the Agency's authorities due to the very recent passage of the Cures Act.

This is the first in a series of three installments that will review the actions FDA took in 2017, reflect on what they may mean for regulated industry, and provide a few predictions for 2018. This first installment, which will be broken up into two posts, focuses on therapeutic products; that is, drugs, biologics, human cells and tissue products, and gene therapies. Our subsequent posts will focus on medical devices and diagnostics, including whole-genome sequencing tests, and digital health and other software-related developments, respectively.

FDA's Drug Competition Action Plan = More Generics and Biosimilars to Market

It will come as no surprise to our regular readers - or to anyone who reads anything for that matter - that high drug prices are a bipartisan "thing" right now and it is all hands on deck to fix the problem. From even before Day 1, given his prior scholarship on this issue, Commissioner Gottlieb was expected to shake things up...