FDA Regulatory

Politics will have an effect on FDA policies in 2021, including with respect to the ongoing COVID-19 response, manufacturing, compliance, digital health, laboratories, user fees, device servicing, and more.

You’d be forgiven in the current climate of coronavirus and election season, to name just a couple hot issues of the day, for missing two recent announcements from the FDA about its digital health program. On September 14, 2020, FDA published “Developing the Software Precertification Program: Summary of Learnings and Ongoing Activities” and the following week, on September 22, launched the Digital Health Center of Excellence.

In this video, Elizabeth Conti provides an overview of “Introduction to the Due Diligence Process,” a high-level guide through the transactional due diligence process from a regulatory affairs perspective, recently published by the Regulatory Affairs Professionals Society (RAPS). Elizabeth co-authored the book with Mintz's Joanne Hawana and Benjamin Zegarelli.

As promised, the Food and Drug Administration (FDA) updated the Purple Book: Database of FDA-licensed Biological Products, providing greater transparency and a more user-friendly search functionality for the biological product and biosimilar industries. Earlier this year, FDA transitioned the Purple Book to a searchable online database. The August 3, 2020 release offers additional information on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER) expanding the dataset used by the database. FDA also updated the available exclusivity information for further industry ease of reference. This update is the next phase of the agency’s plan to improve the accessibility of information related to biological products through expansion and digitization.

Despite the COVID-19 pandemic, the House Energy & Commerce Committee continues work on several health policy issues, including Orphan Drug Act reform and continuous manufacturing.

The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two proposed rules – one from CMS and another from the Office of Inspector General – issued late last year, aimed at reducing barriers to value-based arrangements, which we discussed here.) CMS released its new proposed rule to “support state flexibility to enter into innovative value-based purchasing arrangements (VBPs) with manufacturers, and to provide manufacturers with regulatory support to enter into VBPs with payers, including Medicaid.”