Dec. 21, 2020 – As President-elect Joe Biden takes office in January 2021, understanding what could change and what could remain the same at the FDA is important, according to Nancy Bradish Myers, president and CEO of Catalyst Healthcare Consulting Inc. Myers, who has held key positions at the FDA and in industry, spoke at a Dec. 16 Coalition for Healthcare Communication webinar, “FDA 2021 Outlook: Keeping a Collective Foot on the Medical Product Accelerator.”

With 20 percent of the U.S. economy under the purview of the FDA, “the success of the health marketing communications industry depends very heavily on the FDA’s science-driven, efficient and credible process for approving new drugs and for its clear policies on how to regulate the promotion of those drugs,” said Coalition Executive Director Jon Bigelow. “The FDA has a huge responsibility and workload even in the best of times, and 2020 has not been the best of times.”

Myers outlined the FDA’s 2020 COVID accomplishments, which include the Coronavirus Treatment Acceleration Program, the COVID-19 Pandemic Recovery and Preparedness Plan, and the public-private partnership, Accelerating COVID-19 Therapeutic Interventions and Vaccines, and lauded the agency’s ability to increase coordination, collaboration and communication while also staying on track with non-COVID product approvals. “As we look forward to 2021, the big question is: Are we at the end of the beginning with COVID or at the beginning of the end?” she asked. “Many people in public health will argue that we are at the end of the beginning.”

While the FDA waits for a new commissioner – it is highly unlikely that current Commissioner Stephen Hahn will be asked to stay – the agency will keep going full steam ahead with meetings, reviews, inspections and enforcement, policy progress, communications and stakeholder outreach, and user fee negotiations, she indicated.

“I believe the administration is going to feel like they need to do things to inspire confidence in the FDA and the FDA’s gold standard reputation,” including more inspections and enforcement, while at the same time the agency has a real opportunity to take lessons learned from COVID pilot programs, she said. “Those are the issues that I think the next FDA commissioner is going to have to grapple with – how do you do both? FDA is really going to need a confirmed commissioner who is dynamic and trustworthy, but at the same time a visionary leader,” she continued.

Indeed, a key anticipated priority of the FDA under Biden will be considering agency administrative and procedural changes to expedite and assist with reviews, which clearly would speed up drug development time. “During COVID, things have been sped up and unnecessary things have been pushed to the side,” Myers noted. “FDA is on a very efficient path right now. It would behoove the next commissioner to really take a look at what was done and what should stay” in place.

However, she said, regardless of who is in charge, existing FDA Center-driven priorities are likely to remain, with a focus on a drug competition action plan, a biosimilars action plan, a complex innovative trial design program, a model-informed drug development program, innovation in medical evidence development and surveillance, and an opioids action plan. Further, the FDA Centers will seek to employ digital health technology strategies (to modernize clinical trials and utilize real-world data); advancing and adequately resourcing the Center for Biologics Evaluation and Research is a bipartisan priority that will be front and center.

In Myers’ view, possible Biden choices for FDA commissioner could include Luciana Borio, M.D.; Sue Desmond-Hellman, M.D.; Aaron Kesselheim, M.D.; David Kessler, M.D.; Joshua Sharfstein, M.D.; and Eric Topol, M.D. She advised webinar attendees that the personal interests of each potential candidate – be they drug pricing, tobacco, clinical trial diversity or bioethics, to name a few – likely will shape how each would serve in that role.

During the Senate vetting process, a candidate’s track record will be examined. “If the Senate is very supportive of him engaging in that area, it’s very likely something will happen, but if the Senate does not like that approach, it may pressure him away from it,” Myers suggested. She added that management experience is key to the success for someone in this role. The agency needs “someone who gets things done, who doesn’t just talk about it but is a doer.”

In the first 100 days, Myers anticipates that the Biden administration’s approach with FDA will prioritize four themes:

• Focus on COVID – continuing vaccine emergency use authorization reviews, approvals, post-marketing surveillance, advancing treatments and novel technologies;
• Gold standard – rebuilding public trust and perception of the agency, implementing regulatory “lessons learned” from the pandemic, re-engaging in the global regulatory arena;
• Health disparities – making headway on reducing racial disparities in healthcare;
• Refocused priorities – taking a fresh look at tobacco regulation, food safety and nutrition, and cures for cancers.

FDA’s approach to healthcare communications may be a bit in flux following the retirement of Office of Prescription Drug Promotion (OPDP) Director Tom Abrams, Myers said. Catherine Gray, who is serving as acting director of OPDP, “has already talked about initiatives [OPDP] wants to shorten the review of core advertising packets and trying to expedite review on those,” Myers shared. She also mentioned that although industry has been expecting formal guidance on social media promotion for several years, the timing on this initiative is still not clear.

In spite of the tremendous upheaval headed the FDA’s way, the agency continues on track with negotiations for the Prescription Drug User Fee Act VII (PDUFA VII), Myers stated, with public notification of the negotiated agreement slated for Spring 2021, a post-negotiation public meeting planned for Summer 2021, and the publication of the tentative PDUFA VII agreement in the Federal Register scheduled for Fall 2021.

According to Myers, the successful negotiation of user fees and significant increases to the FDA’s budget as requested will be critical in determining the speed and timing of FDA’s evolution in 2021 and beyond.

“If COVID could have a silver lining, the silver lining might be that the FDA will look at new ways of running the agency and interacting to move things forward,” she told CHC webinar attendees, especially when it comes to better sponsor communication and use of digital health tools. “If you could use all of these, that could speed things up tremendously, but the FDA can’t accept everything, all the time, so it will be interesting to see how they thread that needle.”