Senior FDA leaders pledge to follow science

Sept. 11, 2020

Eight senior FDA leaders penned an op-ed, reassuring the public that the agency will continue to base public health decisions on sound science.

In the letter, the authors, who collectively are responsible for over 17,000 employees and have over 100 years of experience at the FDA, acknowledge recent skepticism and the reality that the agency must operate in a political environment. The officials discuss the dangers of eroding public trust. "This is problematic under normal circumstances but especially if we are to ultimately overcome COVID-19," the letter states.

The authors pledge that they will continue to make decisions guided by the best evidence, maintaining the agency's "gold standard" approach.

The letter was signed by: Patrizia Cavazzoni, Acting Director of CDER; Peter Marks, Director of CBER; Susan Mayne, Director of the CFSAN;Judy McMeekin, Associate Commissioner for Regulatory Affairs; Jeff Shuren, Director of CDRH; Steven Solomon, Director of CVM; Janet Woodcock, Director of CDER (on detail to the Office of the Commissioner) and Mitch Zeller, Director of CTP.

Last week, CEOs from nine major pharma companies came together to sign a pledge related to the safety of coronavirus vaccines. In the statement, the company heads all agreed to not submit a vaccine for regulatory approval until it has been proven to be safe.