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A Well Illuminated Process of Decision-Making

May 9, 2016

As described on Wikipedia, “a black box is a device, system or object which can be viewed in terms of its inputs and outputs without any knowledge of its internal workings. Its implementation is ‘opaque’ (black)” and “The opposite of a black box is a system where the inner components or logic are available for inspection”.

Decision-making in government often functions like a “black box.” We know the input that compels action (usually a law or executive order). We know the output from a decision (usually a regulation, guidance, or program action). But we know very little about the inner workings — what did decision-makers view as relevant, how did they weight various considerations, why was a specific decision reached, etc.

Public openness is a virtue in government. Ideally, there should be no black boxes. In practice, there are many, including some entire agencies.

I started thinking about this when FDA Commissioner Dr. Rob Califf addressed the Alliance a few weeks ago … and thought about it again during an Alliance meeting this week with outgoing Deputy Commissioner, Mr. Michael Taylor and his successor, Dr. Steven Ostroff. It reminded me how FDA is the opposite of a black box. With FDA decision-making and implementation “the inner components or logic are available for inspection.”

Apart from business confidential information, FDA constantly provides illumination about its thinking. And if the steps are unclear, we know that agency officials are willing to explain through public forums and written explanations. Too many FDA stakeholders take this for granted, perhaps not realizing how unusual it is that FDA is so committed to open process.

While lauding the agency for its openness, it comes with a price. For example, running an active public advisory committee system costs money. So does every speech, meeting, and forum in which FDA staff take time from their work to participate. Meeting-intensive processes, such as patient engagement in drug development, also comes with a cost.

Reducing openness might achieve some savings, but it would clearly be a false economy. The quality of FDA decisions (and the credibility that adheres to them) is very closely tied to the open process that the agency follows. Those interested in black box decision-making should apply elsewhere.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.

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