This week, the Senate officially confirmed Dr. Robert Califf as the new Food and Drug Administration commissioner. The move came after a long, puzzling delay in naming a new agency chief at a time where one was sorely needed. During that period, the Biden administration was left to manage a vaccination rollout and any number of COVID-19 communication issues without strong FDA leadership.

Public health experts agreed that the decline in public confidence in the agency couldn’t truly be addressed until the position was filled. But the confirmation was just one line among many others on the public health priority list for the remaining 10 months of 2022.

At a Coalition for Healthcare Communication webinar Tuesday afternoon, Prevision Policy senior editor Kate Rawson dove deep on that list. Here are five takeaways.

1. The Biden administration must address COVID-19 communications missteps. President Biden’s mantra during his candidacy was that he would restore trust in the Centers for Disease Control and Prevention and “follow the science” with his approach to COVID-19.

Rawson noted, however, “That might have been easier said than done. The administration and especially the CDC has been criticized for multiple missteps in COVID-19 policy and communication of that policy.”

Some of the tomatoes being slung at CDC include questions over changing pandemic guidelines in a confusing manner. During the last year, the CDC shifted its messaging around isolation and quarantine requirements, and changed its recommendations around boosters and mask mandates. In addition, a dearth of COVID-19 tests during the peak of the holiday Omicron surge led many experts — and the public — wondering why the agency wasn’t better prepared.

Rawson noted that, under Biden, the CDC has only held a handful of public briefings — fewer, in fact, than the two dozen it held under President Trump.

“This is a rapidly changing virus and it’s just hard for the science to keep up. But I think it’s also really clear that the administration, and the CDC specifically, has a real communication problem,” Rawson explained. “It’s hard to keep the attention of the American public and, as we can see, it’s really split the country even further than we were.”

2. There needs to be an emergency use authorization pathway beyond COVID-19. The quick development and rollout of COVID-19 vaccines has been touted as one of the pharma industry’s greatest achievements. It was helped along, of course, by the FDA’s emergency use authorization (EUA) pathway, which allows the agency to authorize unapproved medical treatments in crises.

The pandemic has spurred a new conversation about that pathway, and specifically whether it should be used more frequently to authorize treatments for other public health emergencies.

“We’re starting to hear from patient advocates, ‘If we can use EUA during the pandemic, why can’t we use that pathway for the opioid crisis, for products to combat opioid use disorder? Or rare diseases — isn’t that a crisis?’” Rawson noted. “That’s not how the law was meant to be applied, but we’re starting to hear some chatter and noise on that.”

3. The FDA needs to get back on track. Califf enters his second FDA tenure with a long to-do list, including important tasks such as addressing burnout and low morale among agency staffers. Indeed, the FDA has bent under the pandemic strain and, as a result, lost the public’s confidence.

There’s also a crisis in manufacturing inspections and a looming backlog, with thousands of inspections delayed since March 2020. The FDA will similarly need to address longstanding issues with the process that led to a controversial approval of Biogen’s Alzheimer’s drug Aduhelm — an issue Califf has already pledged to address.

4. Cancer Moonshot 2.0 must be fine-tuned — and funded. Biden’s original Cancer Moonshot initiative, launched during the final year of Barack Obama’s presidency, came in the form of a six-year, $1.8 billion governmental effort to end cancer. But the initiative, now in its final year, has unfinished business.

“While I think it’s shone a light on cancer development, it failed to have the impact that was originally intended,” Rawson said. “Biden has talked about ending cancer throughout his campaign and presidency to date, saying it would be a priority for him.”

Moonshot v.2.0 has pro-innovation themes that could carry over from the 2016 version, Rawson noted, but its broader goals otherwise remain undefined. And, somewhat importantly, the initiative currently has no allotted funding.

“There isn’t a lot of information at this point, but the White House has called for an all-hands-on-deck approach to end cancer as we know it,” Rawson said. “This time there’s no proposed funding, and we also just lost [former science advisor to the President] Eric Lander, who was supposed to head it.”

5. Drug pricing reform will happen – or not. Drug pricing reform has been a bipartisan priority for a while, culminating in the inclusion of a legit plan for pricing reform in the Build Back Better bill late last year.

But the bill was shot mostly dead at the outset of 2022, when Senator Joe Manchin declared his opposition to the package. While that significantly complicated what appeared to be an inevitable march to significant reform, Rawson believes it will remain a top issue in 2022.

“One way or another, this could be the year where the debate finally ends,” Rawson said. “If Democrats can’t get something passed before midterms, it’s hard to see where they’ll have another chance in the near term. At the same time, I’d argue that reform efforts aren’t over, and Democrats are already highlighting drug pricing as a key element they’ll be able to salvage out of BBB.”

Rawson outlined three different scenarios that could come to play in regards to drug pricing reform, the most unlikely being that Build Back Better becomes law in its current form. Somewhat more likely is a scenario in which many of its provisions, including the drug pricing reform scheme, are migrated into a new bill, with a different name.

The most likely scenario, however, is that Build Back Better never happens, in any form, and drug pricing remains a pivotal issue on the campaign trail.

“This would be good news for the industry in the short run, but a cloud of uncertainty would hang over the sector for the foreseeable future,” Rawson said.