Posted 12 March 2020 | By
At a House Appropriations subcommittee hearing to review the US Food and Drug Administration’s $6.2 billion budget request for FY2021 on Wednesday, lawmakers questioned FDA Commissioner Stephen Hahn on his agency’s response to the coronavirus disease (COVID-19) outbreak, drug supply chain security and foreign inspections.
Coronavirus Testing
Subcommittee Chairman Sanford Bishop (D-GA) initiated the barrage of questions by asking why the US lagged behind other countries in testing for the coronavirus and why the FDA took so long to issue recommendations for test developers looking to develop their own coronavirus diagnostics.
Hahn defended FDA’s response stating, “At the beginning of the outbreak … prior to any US cases, FDA reached out to developers who we work with regularly and in the context of past public health emergencies as we’ve done in the past to encourage the development of tests.”
He noted that the agency granted an emergency use authorization (EUA) to the Centers for Disease Control and Prevention (CDC) test on 4 February and said that the agency is “engaged with over 50 developers” on pre-EUAs.
FDA also issued guidance in late February relaxing rules for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments to validate and run their own tests, so long as they submit an EUA within 15 days.
Supply Chain and Manufacturing
The coronavirus outbreak has raised concerns in some corners that the US is too reliant on China, India and other countries for manufacturing finished drugs and active pharmaceutical ingredients (API).
During the hearing, Rep. Robert Aderholt (R-AL) and Rep. Andy Harris (R-MD) asked whether Hahn felt the US drug supply chain was safe given its heavy reliance on imported products and FDA’s decision to postpone most foreign inspections.
While Hahn said he believes the US drug supply is “safe and secure,” he acknowledged that FDA does not always have “full and robust information about the supply chain,” and that the agency needs to look into manufacturing redundancies and where APIs and finished drugs are sourced. Hahn also testified that FDA needs legislative authority to require medical device manufacturers to notify it of shortages.
On inspections, Hahn stressed that all the routine surveillance inspections being put off will be conducted at a later date.
Looking forward, Hahn said that moving to advanced manufacturing can promote more agile production of drugs and medical devices in the US.
“I think we have to do whatever we can to stimulate advanced manufacturing in pharmaceuticals and to encourage domestic production. I think that will give us the appropriate redundancy and allow for essential medicines and vaccines, in particular, to ramp up when we need to,” he said.
Hahn added that FDA has been providing technical guidance on advanced and continuous manufacturing “so there’s some regulatory certainty for pharmaceutical companies.”
Towards the end of the hearing Aderholt informed Hahn of the World Health Organization’s pandemic declaration for COVID-19.
Hahn responded that while the declaration was important, he stressed that it “doesn’t change what we need to do in this country.”
Hearing
Coronavirus Testing
Subcommittee Chairman Sanford Bishop (D-GA) initiated the barrage of questions by asking why the US lagged behind other countries in testing for the coronavirus and why the FDA took so long to issue recommendations for test developers looking to develop their own coronavirus diagnostics.
Hahn defended FDA’s response stating, “At the beginning of the outbreak … prior to any US cases, FDA reached out to developers who we work with regularly and in the context of past public health emergencies as we’ve done in the past to encourage the development of tests.”
He noted that the agency granted an emergency use authorization (EUA) to the Centers for Disease Control and Prevention (CDC) test on 4 February and said that the agency is “engaged with over 50 developers” on pre-EUAs.
FDA also issued guidance in late February relaxing rules for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments to validate and run their own tests, so long as they submit an EUA within 15 days.
Supply Chain and Manufacturing
The coronavirus outbreak has raised concerns in some corners that the US is too reliant on China, India and other countries for manufacturing finished drugs and active pharmaceutical ingredients (API).
During the hearing, Rep. Robert Aderholt (R-AL) and Rep. Andy Harris (R-MD) asked whether Hahn felt the US drug supply chain was safe given its heavy reliance on imported products and FDA’s decision to postpone most foreign inspections.
While Hahn said he believes the US drug supply is “safe and secure,” he acknowledged that FDA does not always have “full and robust information about the supply chain,” and that the agency needs to look into manufacturing redundancies and where APIs and finished drugs are sourced. Hahn also testified that FDA needs legislative authority to require medical device manufacturers to notify it of shortages.
On inspections, Hahn stressed that all the routine surveillance inspections being put off will be conducted at a later date.
Looking forward, Hahn said that moving to advanced manufacturing can promote more agile production of drugs and medical devices in the US.
“I think we have to do whatever we can to stimulate advanced manufacturing in pharmaceuticals and to encourage domestic production. I think that will give us the appropriate redundancy and allow for essential medicines and vaccines, in particular, to ramp up when we need to,” he said.
Hahn added that FDA has been providing technical guidance on advanced and continuous manufacturing “so there’s some regulatory certainty for pharmaceutical companies.”
Towards the end of the hearing Aderholt informed Hahn of the World Health Organization’s pandemic declaration for COVID-19.
Hahn responded that while the declaration was important, he stressed that it “doesn’t change what we need to do in this country.”
Hearing
