An X-Like Prize for Regulatory Science

And now for something a little different. This week, the agency announced a competition designed to promote new ideas for rapid, accurate detection of disease-causing salmonella in food. As described here, here, and here, the agency is using a relatively new government authority that permits solution-oriented public competitions addressing difficult challenges faced by federal agencies. This is modeled on the successful private sector X Prize program.Whether this program will work -- either the larger competition model for the federal government or the salmonella competition for FDA -- is yet to be determined. Only time will tell.However, the announcement of the competition points to three important themes about FDA:

FDA’s work is infinitely challenging.  We hope that most FDA employees, including its leadership, can go home each night feeling they have accomplished something productive and meaningful to advance the health and well-being of Americans. However, FDA as a whole, has no such luxury. It has a complex and far-reaching mission that can never be fully realized. It must always strive to do more and to do better. This applies to the agency across the board. No innovation, no job well done, ends the conversation about “what next?”

FDA is not afraid to try new approaches to fulfilling its mission. I haven’t done a survey to check, but I doubt many federal agencies have jumped into the new authority to run X Prize-type competitions. It is too different from how they have conducted business for decades. Implementing a prize program requires vision, patience, hard work, and a lot of commitment. It would be much easier for FDA to write an article about the need for rapid, accurate detection of salmonella, then circulate it around to see if anyone is willing to work on the problem. That approach can  work, but rarely does. FDA realizes that and dares to try to see whether a new approach might get them a solution and not just more descriptions of the problem. We should wish them good luck with this -- everyone who eats food, including our pets, will benefit.

Regulatory science must be continually improved. We often talk about FDA’s growing commitment to regulatory science. The salmonella competition provides an opportunity to explain in concrete terms what regulatory science is and why it needs to be improved. Existing salmonella testing methods are one of the primary tools that  FDA has to do its job of regulating food to assure a safe supply. If the science can get better -- producing a more accurate test in fewer hours -- than alerts can be sent out sooner, products withdrawn faster and individuals who are sickened can be treated more rapidly for specific symptoms. This is just one example and one method for improving regulatory science, but the agency must be committed to improving all of its tools and methodologies. And while sometimes it is hard to explain, regulatory science is real and improving it is in our collective interest.We sometimes face skepticism about FDA’s need for more resources to accomplish its mission. Just this one program announcement illustrates in several ways why more resources are both justified and earned.

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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