Career FDA Leaders Say Science Is Agency’s Guide

September 11, 2020
BioPharm International

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

Following the release of public statements from representatives of the biotech industry and top executives at bio/pharma companies pressing for adherence to science-based decisions in the development and approval of COVID-19 vaccines, FDA leaders, in a Sept. 11, 2020 opinion column, argued that the agency is committed to such principles, while acknowledging it operates in a political environment.

In the column published on www.USAToday.com, nine senior FDA leaders noted that while the pandemic has presented challenges for the agency, exposing it to controversy and public scrutiny, “protecting the public health is our beacon, and sound science is our guide to navigate controversial waters.”

The agency makes decisions on the safety and effectiveness of medical products based on available science, the authors explained in the statement, and criticism from stakeholders is expected. FDA works best when its experts are “free to do what they do best—follow the science to address public health issues and revise policy if the understanding of science changes,” the authors wrote

“If the agency’s credibility is lost because of real or perceived interference, people will not rely on the agency’s safety warnings. Erosion of public trust will leave consumers and patients doubting our recommendations, less likely to enroll in clinical studies or to use FDA-regulation products when they should to maintain or improve their health,” the statement read. “We will work with agency leadership to maintain FDA’s steadfast commitment to ensure our decisions will continue to be guided by the best science.”

In a poll conducted by the Kaiser Family Foundation, more than half of those surveyed said they would not get a free COVID-19 vaccine if one were approved by FDA before the presidential election.

The statement was signed by nine self-described “senior career civil servants” including Janet Woodcock, director at FDA’s Center for Drug Evaluation and Research (CDER); Peter Marks, director of FDA’s Center for Biologics Evaluation and Research; Steven Solomon, director of FDA’s Center for Veterinary Medicine; and Patrizia Cavazzoni, deputy director for CDER.

Sources:

USA Today

Career FDA Leaders Say Science Is Agency’s GuideKaiser Family Foundation