Fall Unified Agenda: A look at FDA’s planned rulemaking

The Biden administration’s second regulatory agenda for the US Food and Drug Administration (FDA) largely picks up where the previous agenda left off.

Released by the White House Office of Management and Budget last week, the Fall 2021 Agency Rule List contains 85 proposed and final rules the agency plans to issue under FDA’s purview. More than half of those rules pertain to human medical products or their development, with the remainder related to animal medical products, food, and tobacco. While a rule’s inclusion on the agenda indicates that FDA intends to work towards issuing said rule, the agency is not beholden to the timelines it sets in the agenda, and often takes multiple cycles before a rule is issued.

As with the previous Spring agenda, this year’s Fall agenda was released at the tail end of its eponymous season. (RELATED: Unified Agenda: A look at FDA’s upcoming rulemaking, Regulatory Focus 17 June 2021)

Many of the rules are holdovers from previous biannual agendas, such as FDA’s long-awaited proposed rule on modernizing its medical device quality system regulation to harmonize with the international standard, ISO 13485:2016.

As with the previous unified agenda, the Fall agenda is accompanied by a similar preamble, stating that, “This Agenda presents the regulatory activities that the Department expects to undertake in the foreseeable future to advance this mission. The purpose of the Agenda is to encourage more effective public participation in the regulatory process. The regulatory actions forecasted in this Agenda reflect the priorities of HHS Secretary Xavier Becerra and the Biden-Harris Administration. Accordingly, this Agenda contains rulemakings aimed at tackling the coronavirus disease 2019 (COVID-19) pandemic, building and expanding access to affordable health care, addressing health disparities and promoting equity, and boosting the wellbeing of children and families, among other policy priorities.”

Among the new rules appearing on the agenda that were not listed in the Spring 2021 agenda are a rule on biologics regulation modernization, additional amendments to the list of bulk substances that can be used to compound drug products, and a rule on clinical holds in medical device investigations.

The proposed rule on biologics regulation modernization “would update Food and Drug Administration (FDA) biologics regulations to account for the existence of biosimilar and interchangeable biological products. The rule is intended to support competition and enhance consumer choice by preventing efforts to delay or block competition from biosimilar and interchangeable products.”

Agency Rule List – Fall 2021

Fall Unified Agenda: A look at FDA’s planned rulemaking

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