Five takeaways from the Coalition for Healthcare Communications webinar

This week, the Senate officially confirmed Dr. Robert Califf as the new commissioner of the Food and Drug Administration. The move came after a long and confusing delay in appointing a new agency head at a time when one was badly needed. During this period, the Biden administration has been left to manage a vaccination rollout and a number of COVID-19 communications issues without strong leadership from the FDA.

Public health experts agreed that declining public trust in the agency could not really be fixed until the position was filled. But the confirmation was just one line among many on the list of public health priorities for the remaining 10 months of 2022.

In a Coalition for Healthcare Communication webinar on Tuesday afternoon, Prevision Policy Editor-in-Chief Kate Rawson digs into that list. Here are five takeaways.

1. The Biden administration must correct miscommunications related to COVID-19. President Biden’s mantra during his candidacy was that he would restore faith 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 in particular the CDC have been criticized for multiple missteps in COVID-19 policy and the communication of that policy.

Some of the tomatoes thrown at the CDC include questions about changing pandemic guidelines in a confusing way. Over the past year, the CDC has changed its messaging regarding isolation and quarantine requirements, and changed its recommendations regarding recalls and mask mandates. Additionally, a shortage of COVID-19 tests at the peak of Omicron’s holiday surge has led many experts — and the public — to wonder 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 has held under President Trump.

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

2. There must be an emergency use authorization pathway beyond COVID-19. The rapid development and deployment of COVID-19 vaccines has been touted as one of the pharmaceutical industry’s greatest achievements. He was aided, of course, by the FDA’s emergency use authorization (EUA) pathway, which allows the agency to authorize unapproved medical treatments in the event of a crisis.

The pandemic has sparked a new conversation about this pathway, and specifically about 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 this pathway for the opioid crisis, for products to address use of opioids? Or rare diseases – isn’t that a crisis? “Rawson noted. “That’s not how the law was supposed to be enforced, but we’re starting to hear chatter and noise about it.”

3. The FDA needs to get back on track. Califf begins his second term at the FDA with a long to-do list, including important tasks such as dealing with burnout and low morale among agency staff. Indeed, the FDA bowed under the pandemic pressure and, as a result, lost the public’s trust.

There is also a crisis in manufacturing inspections and a looming backlog, with thousands of inspections delayed since March 2020. The FDA will also have to resolve longstanding issues with the process that led to controversial approval of the drug Aduhelm. of Biogen against Alzheimer’s disease – a problem that Califf has already pledged to address.

4. Cancer Moonshot 2.0 needs to be refined – and funded. Biden’s original Cancer Moonshot Initiative, launched in the final year of Barack Obama’s presidency, took the form of a six-year, $1.8 billion government effort to end cancer. But the initiative, now in its final year, has unfinished business.

“While I think it shed some light on cancer development, it didn’t have the impact originally intended,” Rawson said. “Biden has spoken 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, importantly enough, the initiative currently has no funding allocated.

“There’s not a lot of information at this point, but the White House has called for a comprehensive approach to ending cancer as we know it,” Rawson said. “This time there is no funding offered, and we also just lost [former science advisor to the President] Eric Lander, who was to direct it.

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

But the bill was mostly shot down in early 2022, when Sen. Joe Manchin declared his opposition to the package. While that has significantly complicated what seemed like an inevitable march toward significant reform, Rawson believes it will remain a major issue in 2022.

“One way or another, this could be the year the debate finally ends,” Rawson said. “If Democrats can’t get something passed before midterm, it’s hard to see where they’ll have another short-term chance.” At the same time, I would argue that reform efforts are not over, and Democrats are already pushing drug pricing as a key thing they can claw back from the BBB.

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

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

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

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