Science For Saving Lives: Senior FDA Career Executives

The Food and Drug Administration has already received a lot of comments recently. A lot of things have been written as well said about the Administration. Now, the independence and integrity of the agency have already been questioned.

FDA career executives said, “We are senior civil servants, and our job is to give directions to various FAD centers. Altogether, we are responsible for more than 17000 employees, and in total, we have over 100 years of experience at the FDA. We care deeply about our agency’s mission and its people.” “The FDA currently running was created a decade before the pandemic occurred in 1918. Our predecessors are established by Congress and later in the Department of Agriculture’s Bureau of Chemistry. It was created to protect people from unsafe remedies and foods.”

“Since then, the scope of the agency has been increased, and today we work even on addressing emerging public health issues as well. We even focus on promoting innovation, along with ensuring the safety of the products regulated. “ “But, fundamental and foundational principles of FDA remained steadfast. ‘To protect as well as promote the well-being and health of the American public.’Our decisions should base in support of the sound science and public health mission.”

The integrity and independence of the FDA agency are now in question after a lot has been written and said about it. There are plenty of challenges the FDA has faced during the pandemic. Coronavirus challenges for FDA  “In the past, over these many years, the Food and Drug Administration has already faced a lot of criticisms and challenges. But, meantime, we also understand that challenges always come along with the territory. It is nearly impossible for an agency with reach and impact such as the FDA to complete its job without any disagreement and controversy. Especially these controversies are common when life and health areat risk. But, we understand that protecting public health and life is our beacon, and our guide is sound science. Sound science has always supported us in navigating controversial waters. We always and even now want to stay true to our mission since we want to fulfill our duty to public health.”

The country is facing new challenges presented by a coronavirus. It is giving new challenges to all levels of government and even to the entire health care community, including the FDA. For the effectiveness of medical products and safety, we are making continuous decisions, and they are based on the sound science available, even though there is no clear scientific picture. Of course, such decision-making is facing a lot of criticism from our stakeholders. This is a free society, and here scientific information is open for debate. But, we believe that FDA is best when it comes to its scientific and clinical decisions. Other experts are always available to do what they do best. But, everyone should follow the science when it comes to public health. The policy can be revised if in case there is a change in the understanding of science.

We always understand that, like any other federal executive agency, even FDA operates inside a political environment. Hence we need to realize that there is a need to navigate adeptly and meantime maintain our independence and ensure the best possible outcomes targeting public health. When we consider decisions for authorizing or even approving the products we regulate and actions we take when we uncover safety issues, we as a team always do the best by considering the public health since we are decision-makers for them. We try to arrive at those decisions that are entirely based on our unbiased evaluation of sound scientific evidence.

It is most vital for us to maintain the American’s trust in the Food and Drug Administration. If, in case ours or the agency’s credibility is lost due to either perceived or real interference, people will never rely on safety warnings given by the agency. In case if there is an erosion of public trust, then it will result in inpatients and consumers doubting our recommendations. They will stop their enrollment in clinical studies and examine to use FDA-regulated products for improving and maintaining their health. These issues will lead to problematic situations even in normal circumstances, but it is a challenge, especially when we try to come out of pandemic due to COVID-19. Hence we always try hard to protect the FDA’s independence that is essential if we want to do the best possible things and our job in saving lives and protecting public health.

Our beacon is nothing but the health of Americans. THE entire FDA agency and its staff are entirely dedicated to advancing public health. We are a team of pharmacists, physicians, nurses, veterinarians, engineers, microbiologists, nutritional scientists, toxicologists¸toxicologists, and many more professionals. We even work as support staff when it comes to sharing a joint mission. But there is one thing in common that, all of us have dedicated our professional lives to improving public health. In past years, we have imbibed ideas and opinions brought to the plate by our stakeholders, and most of them seemed promising in the initial stage. But, most of them flawed when they are subjected to scientific reviews.

Hence we always try to innovate and learn whether it is regulating food and medical products, or even tobacco products. That is why we state that we always followed the scientific method, and hence we have an FDA team. We have always worked and continue to work with agency leadership for maintaining FDA’s commitment. The commitment towards ensuring all our decisions and we make sure our choices are always guided by sound science. Our approach remained and continues to stay as a gold standard on which everybody can rely on.  We want the entire nation and American people to understand that the whole FDA team, including over 17000 staff, are working best of our ability on their behalf. We are working with their well-being and health as our beacon.