Feb. 21, 2022 – During President Joe Biden’s first year in office, his administration’s health policy team has faltered, made missteps and miscalculations on COVID-19 decisions and communication, and took more than a year to secure a permanent Food and Drug Administration Commissioner (Robert Califf, M.D., was confirmed to take the helm on Feb. 15).

As the Biden administration enters year two, keeping a focus on its priorities – which include a proposed Advanced Research Projects Agency for Health (ARPA-H) and a renewed “Moonshot” to end cancer as we know it – will be an interesting balancing act.

Speaking at a Feb. 15 Coalition for Healthcare Communication webinar, “Biden’s Health Policy Priorities: Where We Are and What’s to Come,” Prevision Policy Senior Editor Kate Rawson explained that Biden’s large team of health policy players – some of whom are dedicated to COVID-19 work – have faced challenges and incurred some forced errors during the past year.

Health policy staff’s rocky start

White House COVID Response Coordinator Jeffrey Zients “seems to have the closest ear of the President,” and, interestingly, “he’s also largely stayed out of the spotlight when it comes to criticism of the White House response,” Rawson said.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, M.D., has not been so lucky. Walensky has been criticized for “multiple missteps in COVID policy and communication of that policy,” according to Rawson, who noted that although some of that may be politically motivated, the CDC’s shifting policies on isolation and quarantine requirements, mask mandates for vaccinated individuals, booster shot recommendations and a lack of COVID-19 tests may deserve at least some of the negative press it has received.

Much of this struggle “is due to the fact that this is a rapidly changing virus and it’s hard for the science to keep up, but I think it’s also clear that the [Biden] administration, and unfortunately the CDC specifically, has a real communication problem,” Rawson noted. When it comes to the ongoing pandemic, the realities of a short American attention span and a sharply divided nation “really do require a clear and consistent message from all the players,” and “that hasn’t always been achieved,” causing “a lot of confusion that’s led to a credibility crisis.”

Walensky has also been berated “for making policy decisions without consulting with the other players, which has left the administration scrambling at times to explain some of her public comments,” she said. Perhaps as a result, the CDC “has been sidelined by the White House,” Rawson added, calling attention to the fact that there were more than two dozen CDC briefings in 2020 during President Donald Trump’s last year in office, and just five during 2021.

Although Walensky, Chief Medical Advisor Anthony Fauci, M.D., and to a lesser extent Acting FDA Commissioner Janet Woodcock, M.D., have been the public faces of the administration’s pandemic response to date, Department of Health and Human Services Secretary Xavier Becerra has been absent from the public eye – and the conversation, Rawson remarked.

“You could argue that his role wasn’t to be in charge of the response or have an active role in it since public health is not his area of expertise and he’s not an M.D.,” she said, adding that his background as former California Attorney General is more suited to his role in shoring up the Affordable Care Act (ACA). However, although the White House has said Biden remains confident in Becerra, there are “reports that administration officials are frustrated with the job he has been doing with the pandemic,” she stated.

Further, the recent resignation of Chief Science Advisor Eric Langer, who left amid reports of him mistreating subordinates, “puts a crimp in the president’s reinvigorated cancer Moonshot initiative,” as well as efforts to create ARPA-H, which Langer was slated to lead, according to Rawson. However, following the webinar, it was announced that newly retired National Institutes of Health (NIH) Director Francis Collins – who was keen on seeing ARPA-H reside within NIH – will be stepping into Langer’s role for the time being.

FDA-regulated industries will be watching to see how the priorities of Califf mesh with Biden’s priorities, considering Califf did not appear to get much support from the White House leading up to his confirmation, Rawson commented. She added that naming and following through on a permanent FDA Commissioner would seem like a more pressing matter to the Biden administration than it seemed to be – especially in light of an ongoing pandemic.

Califf’s confirmation vote, Rawson predicted earlier in the day, “will be an awkward end to an awkward transition at FDA.”

Biden’s health policy, FDA priority list

In addition to managing the COVID response and addressing pandemic preparedness, top priorities of the Biden administration on the health policy front include:

• Bolstering the ACA against potential Republican majorities;
• Drug pricing; and
• “Build Back Better” (BBB) infrastructure plan

In her estimation, although there is a chance that a recrafted BBB centering on healthcare and drug pricing and dropping any mention of price negotiation could pass under a new name, the most likely outcome is that BBB efforts will fail and that drug pricing will get carried forward as a campaign issue.

For the FDA, “the number one priority is always staffing and recruitment,” Rawson stated, adding that the FDA Commissioner “is eventually going to have to open White Oak” (the FDA’s campus in Silver Spring, Md.), which has been closed since the pandemic hit in 2020.

She identified the following as among the immediate priorities for the FDA to handle:

• COVID vaccine oversight
• Accelerated approval confirmatory study requirements
• Opioid crisis
• Reduction in manufacturing inspections backlog
• Passage of user fee authorization legislation before Oct. 1

The user fee authorization legislation is “must pass,” she said, sharing that Cures 2.0 and ARPA-H, which are “explicitly tied together,” are likely to be the legislative vehicles for user fee bills. Where ARPA-H would be located – under NIH, as Collins advocated for, or under the broader HHS umbrella – remains to be seen. ARPA-H, which would support research projects for high-priority breakthroughs, could get $6.5 billion in funding under the most recent proposals being considered, less than 10 percent of the NIH’s $51 billion funding.

On the other hand, Biden’s Moonshot initiative – which follows an earlier initiative under the Obama administration – has no proposed funding attached to it, although the White House says it is taking an “all-hands-on-deck” approach and “is calling on Congress to fund the program,” Rawson explained.

“Immediate action items are not well-defined, so it’s hard to tell whether the second rendition will have more of an impact than the first,” which she said “shone a light on cancer drug development but failed to have the impact that was originally intended.”

To view Rawson’s slides from the Feb. 15 webinar, click here.