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In Praise of Predictability

FDA has always found it challenging to make its actions predictable. This problem will worsen for a number of months while Dr. Hamburg redefines the agency’s mission, policies, actions and working assumptions. Once this has been accomplished, the agency will become dramatically more predictable to stakeholders, including Congress.

I have written how Drs. Hamburg and Sharfstein’s public health backgrounds make them different from their predecessor over the last 35 years–who were mostly researchers, teachers and clinicians from academic health centers. “Public health” as practiced in a big city health department has a gritty immediacy that shapes every activity. In contrast, academic health centers are devoted to providing clinical services to patients and educating students and house staff. Public health is a valuable by-product, but rarely a primary mission.

“Predictability” also means something different in city government than it does at a university. Public health departments are on the frontlines for all public health decisions–from the availability of flu vaccine to monitoring restaurants for sanitary conditions. Leadership must persevere in the chaotic environment of a big city. Every day brings unpredictable events generated by external forces. Success is achieved by having a tight organizational structure and “standard operating procedures” (SOPs) that cover nearly every potential challenge. In most situations, employees, stakeholders, mayors, and councilmen know what to expect. .

Unpredictable external events play a much smaller role in the life of an academic medical center. The combination of a medical school, a teaching hospital, and biomedical research labs is considered one of the most complex systems in our society. Leadership is more inwardly focused, trying to make the different components work together….and work well. Organizational predictability almost always take a backseat to people management, work flow and revenue generation.

My point is that Drs. Hamburg and Sharfstein have been schooled in the value of creating predictability. Generally speaking, their predecessors were not.

Predictability is in short supply at FDA currently–because the new leadership team is identifying the agency’s internal and external problems and constructing appropriate solutions. The “new normal” that eventually emerges will be: more focused in the face of a broadening mission; more committed to serious enforcement; and more dedicated to innovation that is consistent with public health and science.

In the process, agency policies and actions will be increasingly based on SOPs, public and industry guidances, and clear articulation of scientific and legal positions. These will be implemented by a larger, tighter organization that will be more consistent in its decisions.

Although some of this evolution will be painful for FDA-regulated industries….they will eventually benefit from greater predictability and less ad hoc decisionmaking at FDA. And all stakeholders benefit from the increased public credibility that FDA will earn when its decisions are easier to understand, better grounded in science and public health and more predictable.


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