Califf addresses inspections, staffing and COVID response in House hearing

In his first appearance before the 118^th Congress, FDA Commissioner Robert Califf testified about the agency’s oversight of medical product shortages, inspections and its ongoing response to the COVID-19 pandemic.
 
Speaking before the House Energy and Commerce Health and Oversight and Investigations subcommittees, Califf said that the COVID-19 pandemic “underscores the importance of a swift and agile response coordinated across all levels of government and in collaboration with the private sector. While the pandemic has caused great loss across our nation, through extensive communication, dexterity and innovation, we’ve been able to mitigate the impact of the pandemic and prevent innumerable illnesses and deaths.”
 
As he has done at multiple times during his current stint as FDA commissioner, Califf bemoaned the proliferation of healthcare misinformation during the pandemic. “Most unfortunately, the proven effectiveness of authorized and approved vaccines and therapies have been undercut by a constant flow of misinformation causing many Americans to forego lifesaving treatments, leading them to many unnecessary deaths and hospitalizations,” he said.
 
Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) raised concerns about FDA’s practice of virtual meetings and remote work during the pandemic. “When is everybody going to be back to work? When is everybody going to be back to work, or what percentage of employees are back to work, five days a week, what percentage of meetings are via Zoom?” Rodgers asked.
 
“One hundred percent of our employees have been at work every day since the beginning of the pandemic, and will continue to do so,” Califf answered.
 
Rodgers pushed Califf on whether those employees are working in the office. “Many of our employees aren’t in the office to begin with. We have inspectors, we have people reviewing data, we have 200 locations around the country. We have now added back in-person meetings, they’re being scheduled. Interestingly, when I’ve said ‘would you like all in-person meetings?’ the industry, by and large, has said ‘we’d sort of like both,’ because the ability to have a meeting on the spot via Zoom is superior to trying to get a bunch of people to Silver Spring.”
 
Califf also reiterated that the coming end of the public health emergency (PHE) that was recently announced by the Biden administration will not have an impact on the agency’s emergency use authorizations (EUAs). Califf said the agency will issue a Federal Register notice when the time comes to transition EUA products to routine use.
 
Rep. Diana DeGette (D-CO) asked Califf why the agency needs greater authority to regulate laboratory developed tests, as proposed in the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which failed to make its way into the user fee reauthorization package or the Food and Drug Omnibus Reform Act (FDORA) last year.

“We have the authority to regulate, but for decades now there’s been enforcement discretion to basically allow people to pretty much act freely. We want to really fix that so that, again, people can innovate – there’s a framework to do it – but then when there’s a problem, we have the authority to bring it under control,” Califf responded.
 
In response to a question on supply chains from Rep. Gus Bilirakis (R-FL), Califf said “there’s a lot of work to do,” noting that the issue involves FDA, industry, and other parts of the federal government.
 
Bilirakis also asked about FDA’s inspections program, which fell behind on conducting in-person and foreign inspection during the pandemic.
 
“Thanks to the omnibus bill now, we have additional hiring authority in these areas to bring on more people and we’re hard at work in doing it. Our numbers of inspections are growing daily now, and we’re catching up to what was lost during the pandemic,” Califf said, adding that he does not know exactly how many jobs in the inspections area have been filled to date.
 
Rep. Debbie Dingell (D-MI) asked Califf what resources FDA needs to better address supply chain issues and medical product shortages.
 
“As you know, the industry is increasingly developing digitized supply chains. Each company has great detail about its own supply chain but there is no central hub, and right now, our authorities across drugs, devices, biologics are somewhat different – none of them are as complete as they need to be,” Califf said. “Particularly, we need for the companies to notify us when they see a shortage coming, whether it’s because of a manufacturing problem … or because there’s a great increase in demand that they’re forecasting that will outstrip their ability to manufacture the product. Ultimately, I’d like us to envision ten years from now a digitized supply chain that could undergo stress testing like we do for banks and the financial sector now.”
 
In a terse exchange with Rep. Dan Crenshaw (R-TX), Califf pushed back the congressman’s assertion that FDA acts as a barrier to innovation and slowed the availability of medical products during the pandemic.
 
“I’ll say we can always do better, but let me just say, I’ve been on all sides of this fence,” Califf said, noting his history in the private sector, academia and as a regulator. “We lead the world in innovation, we lead the world in new companies, we’re doing better than any other country. I completely disagree with your characterization of this, but of course, we always could do better,” Califf contended.
 
Crenshaw interjected, saying that leading in innovation, “that’s different than saying that our FDA is helping with that, and not inhibiting it.”
 
Califf interrupted, saying “we lead the world in translating ideas into therapies that are effective for us and for the rest of the world by far. As far as I know, no one disagrees with that characterization.”
 
Hearing