8 FDA Execs Say Agency is ‘Following the Science’
As part of FDA’s ongoing effort to reaffirm its independence and integrity in the face of Covid-19 political pressures, the eight career agency executives who oversee the work of the Centers have signed a statement saying they are “following the science to protect public health” in the pandemic. The statement in USA Today was signed by CDER acting director Patrizia Cavazzoni, CBER director Peter Marks, Center for Food Safety and Applied Nutrition director Susan Mayne, associate commissioner for regulatory affairs Judy McMeekin, CDRH director Jeffrey Shuren, CVM director Steven Solomon, CDER director Janet Woodcock (detailed to the Office of the Commissioner), and Center for Tobacco Products director Mitch Zeller.
The eight say they direct the work of more than 17,000 career employees at the various Centers. “We care deeply about our agency, its mission, and its people,” they write. “The integrity and independence of the agency have been called into question.”
Their statement traces the history of FDA and the many challenges and criticisms it has weathered over the years. “It is not possible for an agency with the impact and reach of FDA to do its job without inviting controversy and disagreement, particularly when health or even life is at risk,” the eight write. “Nevertheless, when protecting the public health is our beacon, and sound science is our guide to navigate controversial waters, we stay true to our mission as we fulfill our duty to the public.”
The executives say it is a reality that FDA, like other executive agencies, operates in a political environment. “That is a reality that we must navigate adeptly while maintaining our independence to ensure the best possible outcomes for public health,” they say. “When it comes to decisions to authorize or approve the products we regulate, or to take appropriate actions when we uncover safety issues, we and our career staff do the best by public health when we are the decision-makers, arriving at those decisions based on our unbiased evaluation of the scientific evidence.”
The eight conclude that they will work with agency leadership to maintain FDA’s steadfast commitment to ensuring that its decisions will continue to be guided by the best science. “Our approach has been and must remain the gold standard that all can rely upon,” they write. “We want the American people to know that FDA’s 17,000-plus career staff will continue to work to the best of our ability on their behalf, and with their health and well-being as our beacon.”