Source : Medtech Insight
Outgoing US Food and Drug Administration commissioner Stephen Hahn has signaled that he wants to focus on public health issues in his next career, and continue to address the types of challenges the agency will face in 2021 in approving the best diagnostics testing for COVID-19 and its variants.
Hahn laid out his accomplishments at the FDA over the past year, and issues the agency is having in fighting the pandemic, in a wide-ranging press briefing with health care reporters on 8 January hosted by the Alliance for Health Policy, a Washington, DC, think tank.
He also showcased the FDA device center’s approval of a cardiac ultrasound software device to capture heart images during the briefing and highlighted the need to curb the pandemic to get urgent and elective surgeries back on track.
“I am so dedicated to the public health of this nation – to increasing equity, to helping those who have been most affected by this pandemic, and trying to help.” – Stephen Hahn
Asked what he might do after resigning as the Trump administration’s FDA chief later this month, Hahn said that after a break to relax and reconnect with his family, he anticipates more work in the public health space.
“I’m going to rethink my career, and then I’m going to move forward,” Hahn said. “I can tell you this – I am so dedicated to the public health of this nation – to increasing equity, to helping those who have been most affected by this pandemic, and trying to help with the underlying issues that are associated with that. And I am so proud of the dedicated career scientists and doctors, nurses and pharmacists at FDA.”
Hahn noted that as the US accelerated COVID-19 vaccinations of some of its population in late December, “we can also see an acceleration” of more hospitals performing more high-risk and elective surgical procedures in the first half of 2021.
Use of medtech products – particularly for cardiac, cancer and orthopedic procedures, as well as for laboratory testing and advanced imaging scans that guide health care providers’ medical decision-making – has been somewhat curtailed by hospitals’ and health care facilities’ need to care for people suffering from the coronavirus throughout 2020. That’s a situation Hahn wants to see reversed, he said.
As an example of how the device industry’s fortunes changed during the pandemic, spine sales among orthopedic companies in 2020 dropped by 5.7%, and cardiac and vascular product sales were down by 9%. But at the same time, extracorporeal life support products – including ventilators, respirators, pulse oximeters and diabetes supplies – were in high demand last year. Those stats were recently compiled by Medtech Insight for our annual report on the top 100 medtech companies by sales. ()
“There are a number of [pent-up or delayed] medical procedures that really are going to need to be done,” Hahn said. “Not just the elective ones – and we need to make sure we have the capacity to do that – but this is why the medication and vaccination efforts are so important now. Because we need resilience in the health care system to take care of women with breast cancer, and we need the space to take care of men and women who need heart surgeries.”
Hahn said the FDA has been “monitoring the landscape for genetic variants” of COVID-19 for quite some time, and has been analyzing which molecular tests that it gave emergency use approval (EUA) to in 2020 might be used to detect the variants. A major problem with current COVID-19 tests is that they may fail to find the variants, providing false negative results for patients who are actually infected with a coronavirus variant, making it harder to control the spread of the pandemic. ()
“An RNA virus is likely to mutate, so we need to be vigilant about it. We are also look at any of the tests we have to see if they are ‘dirty screens,’ in other words, have a way of straining for variants,” Hahn said.
Moving forward, the commissioner said the FDA needs to step up its genetic screening to keep track of any variants showing up in molecular tests.
The agency also is working on assessing antigen tests to see if thosecan pick out the coronavirus variants, he said, but determining if an antigen test can do that requires culturing and a special laboratory. “Those assessments are in the works – so stay tuned over the next couple of weeks,” he said.
Hahn also gave a shout out to non-COVID 19-related product authorizations the agency worked on throughout last year, after reiterating the device center’s accomplishments in “playing a key role in EUAs for … diagnostic tests, personal protective equipment, ventilators and other devices.”
In particular, Hahn praised approval of a software device from Caption Health.
“We supported – outside of COVID-19 in 2020 – marketing of more than a hundred medical devices, including the first cardiac ultrasound software that uses artificial intelligence to capture quality diagnostic images,” Hahn said.
The FDA gave de novo authorization in February 2020 to the software, called Caption Guidance. The agency called out the development of the software as a “breakthrough” in a 12 January action plan aimed at artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD). (See sidebar story.)
By Sue Darcey