Jan. 24, 2022 – With the COVID-19 pandemic heading into year three, the Food and Drug Administration (FDA) faces ongoing challenges but continues to work on four primary agency priorities, according to Nancy Bradish Myers, president of Catalyst Healthcare Consulting, who spoke at a Jan. 21 Coalition for Healthcare Communication webinar, “A New Start for the FDA.”

The challenges before the agency are not insignificant, Myers said, and include, among others:

• Focusing not just on the current pandemic, but on future preparedness;
• Returning to a new normal, which, “for an agency the size of the FDA is clearly going to have some management challenges”;
• Navigating congressional agendas heading into the midterm elections that may affect FDA funding and relevant legislative initiatives;
• Overseeing user fee reauthorizations, which “are not a done deal”; and
• Overcoming increased public and payer second-guessing of FDA approval standards, “which is not a place that the agency wants to be.”

Understanding these issues and how they will fit into a chock-full calendar is key to a greater awareness of the tasks before the agency. “It is important to understand what events are happening and how do you slide in your other agenda items into the open spaces,” Myers told webinar attendees about 2022. “Hopefully we will have a confirmed FDA Commissioner soon,” she said, noting that the Senate Health, Education, Labor, and Pensions Committee voted 13-8 recently in favor of nominee Robert Califf, M.D.; a full Senate vote is the next step in the approval process.

She cited vacancies at the Center for Biologics Evaluation and Research, budget Continuing Resolutions (CRs), President Joe Biden’s March state of the union, the Oct. 1 deadline for user fee reauthorization and the Nov. 8 midterm elections as some of the events that will have an impact on the FDA in the coming year.

The user fee reauthorization is “the elephant in the room that is going to drive a lot of conversations about FDA policies,” she remarked. Although an agreement letter for the next iteration of the Prescription Drug User Fee Act (PDUFA) was submitted on time and all parties claim to want “a clean PDUFA,”  the legislation that PDUFA needs to be attached to “often has major initiatives” that can bog down the process.

With 46 percent of the agency’s funding coming from user fees, she said, they are “critically important to the agency.” If user fees get caught up in congressional politics and are not reauthorized, “that would be like a government shut-down, where half of the FDA can’t go to work.”

As the agency grapples with these issues, it also needs to focus on four key areas in 2022, Myers explained:

• Harnessing the lessons learned from COVID-19 (i.e., managing the pandemic response, increasing preparedness, considering new approaches, processes and tools);
• Restoring public trust in the FDA being the gold standard in its reliance on science and good data;
• Managing a fatigued agency by focusing on staff and reorganizations, building a better IT infrastructure, and getting back on track following pandemic delays and resource issues; and
• Delivering clinical trial reform that meets equity and diversity goals, is patient-centered and, includes open-access clinical data and increased use of real-world evidence.

In addition to these items, the FDA is likely to prioritize addressing medical misinformation if Califf becomes the next FDA Commissioner, Myers predicted. “Califf is very concerned about some of the activities that are happening on social media,” she said, and the proposed research by the FDA’s Office of Prescription Drug Promotion (OPDP) focuses on such salient promotional information concerns as using celebrities to promote drug products and particulars regarding direct-to-consumer ads.

To that end, Myers noted that the Center for Drug Evaluation and Research (CDER) recently announced a reorganization – establishing an OPDP Division of Promotion Policy, Research and Operation – designed to focus on the effective communication of drug information.

Other issues likely to be on the agency’s plate under Califf, Myes said, are a top-down review of opiates that will likely have an impact on labeling and prescriber education, and efforts to improve transparency (e.g., the FDA’s recently launched public-facing Risk Evaluation and Mitigation Strategy dashboard).