AdvaMed10.05.20
In an interview for The Virtual MedTech Conference this week, FDA commissioner Dr. Stephen Hahn spoke with AdvaMed president and CEO Scott Whitaker on the importance of Americans’ continued confidence in the integrity of the agency’s science-based product review process.
Avoiding Outside Pressure
“When it comes to looking at data that we receive around a COVID-19 vaccine – and we have to make the assessment around safety, effectiveness, quality manufacturing… those decisions will be made by the career scientists and staff within [FDA’s] Center for Biologics Evaluation and Research,” Hahn said. At FDA, “we have processes in place to make sure that the Centers are protected from any outside pressure, and that they’re focused solely on looking at the science and the data,” he emphasized. “I have absolute faith and confidence in those decisions.”
Switching gears to the upcoming negotiations with industry to reauthorize the FDA medical device user fee agreement, Hahn noted that the agency is “very enthusiastically looking forward to those negotiations.” AdvaMed and the medtech industry have “laid an incredible groundwork … to set the stage for some very successful discussions,” Hahn commented. Acknowledging the FDA’s work responding to COVID-19 will be a factor, Hahn said, “In current user fee negotiations, we’re looking back at how we’ve responded in the pandemic, and we’re incorporating that, and totally expect for that to occur.”
Praise for the Medtech Industry
Finally, the FDA chief praised the medtech industry’s response to the global pandemic, working as part of a public-private partnership with the agency. “My many thanks to AdvaMed, medtech and the entire industry for the unbelievably great work to help the American people,” Hahn said. “The fact of the matter is, in my opinion, we would not have been able to get the medical products we’ve gotten out to the American people, as a country, without that public-private partnership.”
Whitaker concluded: “We join you in our gratitude for the work that the staff at FDA take on every day… We thank you for your clarity and your leadership.”
Avoiding Outside Pressure
“When it comes to looking at data that we receive around a COVID-19 vaccine – and we have to make the assessment around safety, effectiveness, quality manufacturing… those decisions will be made by the career scientists and staff within [FDA’s] Center for Biologics Evaluation and Research,” Hahn said. At FDA, “we have processes in place to make sure that the Centers are protected from any outside pressure, and that they’re focused solely on looking at the science and the data,” he emphasized. “I have absolute faith and confidence in those decisions.”
Switching gears to the upcoming negotiations with industry to reauthorize the FDA medical device user fee agreement, Hahn noted that the agency is “very enthusiastically looking forward to those negotiations.” AdvaMed and the medtech industry have “laid an incredible groundwork … to set the stage for some very successful discussions,” Hahn commented. Acknowledging the FDA’s work responding to COVID-19 will be a factor, Hahn said, “In current user fee negotiations, we’re looking back at how we’ve responded in the pandemic, and we’re incorporating that, and totally expect for that to occur.”
Praise for the Medtech Industry
Finally, the FDA chief praised the medtech industry’s response to the global pandemic, working as part of a public-private partnership with the agency. “My many thanks to AdvaMed, medtech and the entire industry for the unbelievably great work to help the American people,” Hahn said. “The fact of the matter is, in my opinion, we would not have been able to get the medical products we’ve gotten out to the American people, as a country, without that public-private partnership.”
Whitaker concluded: “We join you in our gratitude for the work that the staff at FDA take on every day… We thank you for your clarity and your leadership.”
