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Understanding FDA—Its Strength Is Its People

Science is essential and rules and regulations must be followed…but ultimately it is the people of FDA who determine whether the agency functions well and acts in the best interests of the American people.  For that reason, a recurrent theme in FDA Matters is the importance of FDA employees. Their jobs are much more difficult than most of us imagine.

Consider the oft-expressed paradigm: FDA is committed to science-based decisionmaking. Yet, science doesn’t exist in a pure, understandable, easily accessible and unassailable form. Neither do laws and regulations. While law and science are fundamental to FDA decisions, only people can actually make the decisions.

During 2011, FDA Matters explicitly looked at the role of staff three times.

The first column asked: Will the Real FDA Please Stand Up?  It was in response to a widely circulated e-mail appealing for public support to prevent the firing of “courageous, honest FDA scientists who risked their careers to save lives by informing Congress about serious safety concerns involving dangerous, FDA-approved drugs and medical devices.”

Whistle-blowing is sometimes necessary. However, the image of a corrupt, politicized FDA cynically suppressing dissent and putting the American people at risk is inconsistent with the FDA that I have known and followed for over 30 years. Yet, I acknowledged that the claims made in the e-mail are persistent and come from many sources.

Exploring this in the column, I concluded that FDA is making progress in handling dissent and in encouraging managers to be more open-minded. While FDA makes mistakes, there is no conspiracy. The agency is fully committed to serving the American people. 

My second column, People, Not Science, Make Decisions, looked at why decisions take so long, especially product approvals. When asked about bottlenecks at FDA, I had to admit that people slow the process down. I pointed to three factors that cause delays:

  • FDA lacks sufficient resources.  FDA has been dramatically understaffed for decades, although better funding in recent years has improved the situation. Even still, new demands on FDA are increasing faster than staff can be added.
  • FDA’s culture promotes intensive scientific discussion.  Objective science-based decisionmaking is a goal, not a reality. People arrive at decisions with a bundle of perceptions and experiences that render their judgment subjective. Yet, they wouldn’t have much to contribute without those experiences.
  • Science has become more complex and results often unpredictable. Life sciences’ products are increasingly based on cutting edge discoveries. It takes more time, more thought and more knowledge on FDA’s part to make a good decision about them. 

Finally, I devoted a third column, FDA and Things that Might Go Bump in the Night, to exploring what happens when FDA staff has to decide the fate of breakthrough technology that could bring great benefit or great sorrow to humankind. In the current context, I had nanotechnology, genetically-engineered (GE) animals, and synthetic biology in mind.

Thirty years ago, FDA gave a cautious “yes” to the first biotechnology studies that eventually became important medical products to treat cancer, arthritis, MS and many other diseases. The world is a better place as a result.

In retrospect, the decision was right, but at the time, this wasn’t clear. Scary visions of mad scientists and technology run amok were powerful forces in the early days of biotechnology. In response, FDA staff took great care in setting up an appropriate regulatory environment.

Conclusion: Based on my experiences working with FDA and as expressed in these three columns, I believe that FDA staff–the people contributing to and making the decisions at FDA–are its strength. While they are human and make mistakes, FDA’s employees are smart, conscientious and committed.   


One Response to “Understanding FDA—Its Strength Is Its People”

  1. Sporn says:

    I worked at FDA over 30 years and in an FDA-regulated industry for 11 years. Your article gives an excellent description of FDA and I am complete agreement with your conclusion.

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