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Let’s Praise FDA for What is Going Well!

June 17, 2016

FDA is caught in an existential “Catch-22:” it never draws attention when it is doing things well, only when something goes awry. This is an old story, but I have not seen it discussed again recently.

What brings it to mind is the juxtaposition this week: a supposedly bad news story about two new GAO reports on FDA (really not so bad); and a hopefully good news story about FDA’s commitment to developing “real world evidence” as a complement to evidence derived from randomized clinical trials.

The GAO reports need to be seen in context. GAO is in the fault-finding business. A report from them that says: “x can be done better,” is an every-day event for one federal agency or another. This week it’s FDA’s turn. Although interpreted by some as evidence of FDA’s failures as an agency, in fact the reports are useful, but not a big deal. According to Inside Health Policy,

FDA Commissioner Robert Califf acknowledged the agency’s strategic planning could have been better in the wake of a critical GAO report on the issue.

So, the agency plans to improve its process and do better. Let’s hope that’s the end of it.

Besides, how representative is this GAO-inspired image of FDA as locked into “business as usual,” and not open to strategically planning the future of its medical product centers in a coordinated fashion? I thought the rebuttal was immediately evident in FDA’s participation and openness in the Friends of Cancer Research-sponsored symposium on real world evidence. Given that no federal agency (not even NIH) is more solidly committed to evidence generated by the gold standard of randomized clinical trials, this was the FDA’s acknowledgement that it must confront the future rather than be brought begrudgingly into it. More on the real world evidence concept can be found here.

This is not a matter of FDA, right or wrong. With a mission as complicated and far-reaching as the agency’s, it is inevitable that some things will go wrong. Sometimes that will be by happenstance, other times by bad planning, and still other times by outside events over which the agency has no control. Compared to other government agencies, I think FDA is more forthright than most when there are poor outcomes.

All I think we can ask for (and contribute to) is a policymaker and public perception that FDA is also doing an enormous number of things really well. Even some incredibly complex tasks (making 80% of the food supply safe; balancing risks and benefits with new medical products) are accomplished successfully with very little fanfare. When we talk of FDA, let’s be sure that we point to the many things that are going right and therefore less visible.

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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