In The Press November 18, 2021

Five FDA Policy Themes to Watch For Under New Leadership (Modern Healthcare)

Dr. Robert Califf was nominated by President Joe Biden last week to lead the Food and Drug Administration. If confirmed, Califf will lead an agency still fighting against the COVID-19 pandemic while working to innovate. New COVID-19 therapies are still being developed, like Pfizer's pill put up for FDA authorization earlier this week. Califf will likely be involved in those decisions, said Susan Lee, a partner in Goodwin's Life Sciences practice. The pandemic forced the FDA to allow flexibility and innovative clinical trial design, especially around remote monitoring, Lee said. She expects Califf to continue this push. Lee said enthusiasm around innovative clinical trial designs could lead to lower drug costs down the line, since high costs of drug development contribute to high prices for consumers. Read the Modern Healthcare article here.