FDA’s Wish-List for 2018 Includes Ambitious and Achievable Goals 
​​[Posted on: Thursday, February 15, 2018]

FDA commissioner released a list of priorities for this year that could be categorized into two broad areas: encourage domestic manufacturing, and increase the role of real world evidence (RWE) for product approval. To boost domestic manufacturing, FDA plans to focus its attention of new technologies, particularly for biotechnology products and medical devices. FDA will continue creating new policies aimed at developing high technology platforms that are developed in the US and likely stay in the US for the near future due to low foot print and intellectual property concerns. It also plans to create a “Center of Excellence on Compounding for Outsourcing Facilities” which will create specific and less burdensome GMP requirements for compounding pharmacies. Compounding pharmacies are almost entire domestic operations due to the nature of the business. On the RWE aspect of regulatory innovation, FDA will develop data and analytical tools to conduct near-real-time evidence evaluation down to the level of individual electronic health records for at least 10 million individuals in a broad range of U.S. healthcare settings. The goal is to not only to collect post-market data but also pre-market data from clinical trials to support safety and efficacy of products in the market and those under development in clinical trials. Also, FDA will continue with the digital health initiative from 2017 which involves focusing on the validation of developers’ capabilities and skill set to build software and digital health products, rather than each and every product, and shifting to regulations to post-market oversight. These are ambitious goals; manufacturing location is highly dependent on cost and logistics. So, it is hard to project the effect of these policies in moving manufacturing to the US. These policies are not drastically new but FDA’s continuous engagement in this area will be welcome to the industry stakeholders. Similarly, the initiatives for real world evidence were already committed per the requirements set in the 21st Century Cures Act of 2016. We should know better when the details come later this year. These goals are on track with what FDA has been saying last year. No surprises here, and that’s a good thing.