Healio and MM&M

May 22, 2019

What lies ahead for FDA under Acting Commissioner Ned Sharpless? This article in Healio covers a presentation by Catalyst President Nancy Bradish Myers at the May 22 Coalition for Healthcare Communication’s Rising Leaders Conference on Healthcare Policy in Washington, DC.

Ms. Myers gave a far-reaching talk on why Gottlieb received rave reviews as Commissioner, what to look for under Sharpless’ tenure, and FDA initiatives to watch. In general, she expects Sharpless to continue to implement and support action plans put into place by Gottlieb in 2019, such as the Drug Competition Action Plan and Medical Device Safety Action Plan, the article notes.

“In his role, he wants to focus on the continued use of expedited pathways [and] improve the efficiency of new product reviews. He wants to put out new guidance and transparency for the development of cell and gene therapies, and he wants to continue the implementation of the biosimilars action plan,” she said.

She also addressed US and global political dynamics, noting that they could potentially impact FDA’s progress, for example the 2020 election cycle, growing calls for drug importation and global trade issues.

Overall, the post-Gottlieb FDA “will look very much like the FDA in the Gottleib era, but with fewer Tweets,” an article in MM&M notes based on Ms. Myers’ talk.

“Ned Sharpless is the acting director of the FDA, and at the FDA ‘acting’ tends to mean ‘caretaker,’” the article notes that Ms. Myers said. “I haven’t heard any political buzz behind bringing him in front of the Senate for confirmation hearings before the 2020 election. The longer there’s no buzz, the harder it gets to do that before the election.”