2021 was a dynamic year for the US Food and Drug Administration (FDA) as the agency continued to address the evolving COVID-19 public health crisis and associated challenges impacting the industry. Signs point to increased enforcement as we enter 2022 with a newly confirmed FDA commissioner, the withdrawal of many COVID-19 enforcement policies and the reorganization of key FDA divisions.
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Drugs and biologics
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The second year of the global COVID-19 pandemic contributed to a dynamic regulatory environment for the US Food and Drug Administration (FDA) and industry. FDA issued numerous guidance documents and enforcement policies in 2021 to address the evolving COVID-19 public health crisis and the resulting logistical challenges to manufacturing, supply chain and clinical development. The absence of a confirmed FDA commissioner and a unified policy agenda did not decrease the pace of regulation, particularly with respect to the agency’s response to continued innovation with renewed focus on real-world data, patient-centered product development and cybersecurity. While 2021 saw static or decreased FDA enforcement activity in traditional areas of focus, such as advertising and promotion and manufacturing, the withdrawal of many COVID-19 enforcement policies and the reorganization of key FDA divisions may signal increased enforcement in 2022.
The Biden administration halted or rescinded several rulemakings and guidance issued at the 11th hour by the Trump administration. On January 20, 2021, the Biden administration issued a memorandum to the heads of executive departments and agencies indicating that it would postpone by 60 days the effective date of any rules issued but not in effect as of the date of the memorandum. While the administration has not formally extended the initial postponement, it took no action at the 60-day mark. The delay may reflect the need to shift resources to address the evolving impacts of COVID-19 on various regulatory processes and priorities. On January 20, 2021, the Biden administration also issued an executive order to withdraw any rules that did not publish in the Federal Register by noon that day. The current administration also found itself in the position of defending several lawsuits against Trump administration regulatory actions, many of which allege violations under the Administrative Procedures Act.
While regulation continued apace, the absence of a permanent FDA commissioner throughout 2021 did result in the lack of a cohesive agency-wide policy agenda beyond the obvious concern for coping with the COVID-19 pandemic. Certain controversial areas such as the regulation of hemp and other cannabis-derived products have also been on the back burner, and several key agency positions such as the principal deputy commissioner, chief scientist and chief counsel have remained in an “acting” or vacant status. However, we have seen a cross-center shift prioritizing patient-centric regulatory decision making and patient care. Likewise, many industry stakeholders have shifted their marketing or commercial strategy to focus on patient-centered development, marketing and outreach, using strategies such as patient liaisons and direct outreach to patients or patient advocacy groups. FDA also has been developing guidance policies to incorporate real-world evidence (RWE) regarding patient experiences with various products into decision-making for new therapies.
In mid-November 2021, the Biden administration formally nominated Robert M. Califf, MD, MACC, as FDA commissioner. Dr. Califf is the senior advisor for Verily and Google Health. Previously, Dr. Califf was the vice chancellor for health data science for the Duke University School of Medicine; director of Duke Forge, Duke’s center for health data science; and the Donald F. Fortin, MD, professor of cardiology. He is currently an adjunct professor of medicine at Duke. He served as deputy FDA commissioner for medical products and tobacco from 2015 to 2016, and as FDA commissioner from 2016 to 2017.
During a Senate confirmation hearing in mid-December 2021, some members praised Dr. Califf for his thought leadership regarding clinical trials and potential to address concerns regarding the regulation of e-cigarettes head-on. However, he was also questioned about his ties to industry as a board member, adviser or investor, as well as his role as FDA commissioner amid the opioid drug crisis. On January 13, 2022, the Senate Committee on Health, Education, Labor and Pensions voted to advance Dr. Califf’s nomination to the full Senate. Therefore, the timing of a decision on Dr. Califf’s confirmation is unclear, but it will likely be within the next month, if not sooner.