On Dec. 11, Catalyst President Nancy Bradish Myers spoke as part of a panel on changes in the political landscape impacting the biopharma industry at the FDA/CMS Summit in Washington, DC. Following Commissioner Gottlieb’s announcement of FDA action on biosimilars, and CDER Director Janet Woodcock’s presentation of her priorities for 2019, the panel focused on anticipated major developments at FDA in 2019 and how political dynamics may drive these changes.

One of the key skill sets of the current FDA leadership team is communication, which comes early and often, as Ms. Myers noted.  Among  the things that companies need to do in this regulatory environment is ensure they understand what’s new versus what is not new, she said.

In addition, many changes that are announced at the top of the agency still require additional work, such as guidance development, in order to drive those changes down to the Review Division level.

Overall, FDA is engaging in many initiatives that will occur regardless of the politics; however, politics may drive additional conversations around issues such as: drug pricing; drug safety; the health care system as a whole and achieving greater efficiencies; and potential oversight activities and investigations of the Administration.

With some issues that are gaining attention, we see the pendulum is once again swinging; for example, many of the conversations around “Medicare for all” are similar to those that occurred back in 1994 with the Clinton health care reform effort. Similarly, importation may reappear on the radar as way of addressing drug pricing, given interest from both Sen. Chuck Grassley (R-IA), who will chair the Senate Finance Committee in the 116th Congress, and President Trump.