"Turkey Day" ... and an Expression of Gratitude

Next week is Thanksgiving, a traditional time to focus on the good things for which we are grateful. FDA is near the top of my list. I hope it is on your list, too. On behalf of all of us, the Alliance says: “Thank you, FDA.”In particular, our thanks extend to five areas of FDA’s mission and responsibilities:

1. We should all be grateful for the protection that FDA provides us against unsafe food, drugs, devices, and other products. Serious problems still exist and FDA works diligently to set standards and perform the inspections that minimize consequences. More broadly, it is instructive to read FDA’s long history — and realize tha,t without FDA, we would be faced with multiple unsafe products every day. That was the reality when the FDA came into being more than a century ago.
2. We should all be grateful for the medical products the FDA reviews and approves that lessen the personal and societal burden of illness and disability.  Medical products are a beneficial and broadly available part of our lives. Yet, we take it for granted. When Medicare was created in 1965, there was no “drug benefit” in large part because medications were a negligible part of medical care. It has also been said that in the first half of the 20th Century, most medical visits did not produce any positive outcome -- patients were no better or worse than if they had stayed home and not sought professional medical help. All of this has changed, with FDA the common element in the medical products that have changed how long we live and how well we are each day.
3. We should all be grateful for the FDA’s commitment to flexibility and innovation. There have always been critics of FDA who have accused the agency of inflexibility and resistance to change. And perhaps, some of the time, they may have been right. But that is no longer the way the agency conducts business or thinks of its commitment to the American people. Recently, some of the tussles over FSMA have demonstrated FDA’s willingness to reconsider what it has proposed. So, too, programs like breakthrough drugs reflect the agency’s ability to reassess its processes and adopt new ones to meet emerging needs.
4. We should all be grateful for FDA’s culture that recognizes that the job is never done -- whether the focus is food safety, medical product safety, or approval of medical products. FDA staff are incredibly hard-working. People work long hours to get their jobs done. By itself, that is reason to be grateful. However, it extends beyond that ... to a culture that realizes that safe foods and safe and effective medical products are dynamic challenges. The value of the agency’s work is not diminished just because it can never be completed. Individuals get days off, but FDA never does.
5. Finally, we should all be grateful for FDA’s adherence to the “rule of law” -- the legal principle that law should govern a nation, as opposed to arbitrary decisions by individual government officials. Not everyone is going to agree with every FDA decision. As a result, stakeholders meet with the agency to express their views, send letters, respond to draft regulations and guidances, submit citizen’s petitions, testify at advisory committees and so on, including occasionally suing the agency. Such differences of opinion are to be expected given the importance and complexity of the issues with which FDA must deal every day. Yet, within those many expressions of position and disagreement, you rarely hear FDA accused of either favoritism or vendetta. The rule of law is very much a part of the agency’s approach to its responsibilities.

What about FDA are you grateful for? We would welcome hearing from you. If there are particularly interesting ones, we will discuss them further in columns in December.