Partner David Rosen was quoted in the Inside Health Policy article, “Industry: Biden Admin Must Restore Trust In FDA’s Scientific Decisions,” about how drug and device industry lawyers say the Biden administration will need to focus on restoring the public’s trust in the FDA, especially with emergency authorization requests for COVID-19 vaccines on the horizon.
The FDA’s decision-making hasn’t necessarily strayed from being based on strong science under the Trump administration, said Rosen, who is co-chair of the firm’s Life Sciences Industry Team. However, there have been conflicting messages coming from the White House and FDA, especially around the COVID-19 response.
Rosen said that he believes that with a new administration will come an increased focus on decisions that are backed by appropriate safety and effectiveness standards.
“We need to go back to an approval and clearance systems for drugs, biologics, and medical devices that are based solely on good scientific practices and principles and meeting the statutory requirements,” Rosen said. The American public should have confidence that the products that are approved by FDA meet the applicable standards of safety and effectiveness.