When the Food and Drug Administration approved Biogen’s controversial Alzheimer’s drug Aduhelm last week, skeptics questioned whether the agency had tacitly okayed a medicine that lacked compelling evidence of efficacy. And then there’s the ongoing question over the agency’s leadership, with acting commissioner Dr. Janet Woodcock still at the helm nearly five months into President Biden’s tenure.

Woodcock, who has been criticized for the alleged role she played in perpetuating the opioid epidemic, is now facing a new wave of backlash over the Aduhelm approval. Some Senate Democrats believe it represents another example of Woodcock’s too-close ties to the pharma industry.

During a recent online webinar hosted by the Coalition for Healthcare Communication, Kate Rawson, contributing editor at Prevision Policy, noted that the FDA is on the brink of needing to re-envision its future.

“At the end of the Trump administration, it was an agency that, in the eyes of many, needed to repair a damaged reputation,” Rawson said. “I think that most folks would agree that the FDA has really come out of that period bruised, not broken – that’s in the words of one former commissioner.”

“While once Biden took office, some of the reputational damage has faded away, there is an ongoing concern with morale,” she added.

In the webinar, Rawson outlined the FDA’s current priorities, the first and most obvious being its continuing response to COVID-19. That includes everything from getting vaccines authorized and planning for booster shots to an inter-agency effort to combat vaccine hesitancy and a renewed focus on COVID-19 therapeutics.

Other healthcare priorities include President Biden’s infrastructure bill as well as the proposed Advanced Research Projects Agency for Health (ARPA-Health). The new agency, which would sit within the National Institutes of Health (NIH), is modeled after the Defense Advanced Research Projects Agency. ARPA-H would focus on finding solutions for chronic diseases like Alzheimer’s, cancer and diabetes.

Rawson said while the proposal has some merit, its critics believe that a new agency is unnecessary. They question whether the work may be duplicative of what the NIH already does. Meanwhile, much of NIH’s funding would go towards the new agency: of the $9 billion allotted for NIH, $6.5 billion would be earmarked for ARPA-H.

“It will be interesting to see if Congress picks up on this, as there’s been some excitement about this outside of some conservative corners,” Rawson said.

Meanwhile, the FDA will also have to weigh in on the potential enactment of a patent waiver for COVID-19 vaccines – and whether it would be a one-off event or a sign of things to come.

As for the discussion over who will lead the FDA on a non-interim basis, it has shifted toward new contenders. Rawson noted that while Woodcock remains a top candidate, others on the short list include former Baltimore city health commissioner Dr. Leana Wen and UMass Medical School Center for Translational and Clinical Science director Dr. Katherine Luzuriaga. Rawson dubbed Luzuriaga the “fresh face” of the competition.

Others generating buzz include Biotechnology Innovation Organization president and CEO Dr. Michelle McMurry-Heath and Gayatri Rao, a former FDA official who now works for Rocket Pharmaceuticals.

Still, Rawson said not to count out Woodcock, noting the importance of continuity during the ongoing COVID-19 crisis. “She’s been at the FDA for 35 years and most of that has been at the Center for Drug Evaluation and Research (CDER),” Rawson explained. “She has a very deep understanding of FDA’s needs and is probably the one commissioner that would be able to hit the ground running.”

But leadership isn’t the most pressing issue facing the FDA. Instead, it might be the leadership change at CDER: For the first time in nearly 30 years, there’s a new permanent head at the agency, Dr. Patrizia Cavazzoni.

“Cavazzoni acknowledges she has very big shoes to fill, but this is a much more significant change in a lot of ways than who’s in the commissioner’s office,” Rawson said. “This is the person that oversees all regulation for drugs and biologics.”

CDER’s top priorities are, in some order, to steer out of pandemic work, complete user-fee negotiations and further explore health equity considerations around generics and biosimilars. Rawson believes Cavazzoni’s approach contrasts with the one espoused by former FDA commissioner Scott Gottlieb, who argued that generics and biosimilars are important to combat the rising cost of drugs.

“Cavazzoni is looking at it more from an equity lens,” Rawson noted.

Then there’s renewed attention on the Center for Biologics Evaluation and Research (CBER), which Rawson called the “sleepier, younger sister to CDER.” While CBER has focused on vaccines during the pandemic, the center will eventually shift its attention toward cell and gene therapies.

“You’re going to start seeing CBER getting a lot more funding, as they need to staff up to address the influx of cell and gene therapies coming down the road,” Rawson explained. “They’ve been able to attract some young talent, and there’s a shift in how the public sees the center.”