New FDA Commissioner: “It’s About the Pain”

If you’re in the business or profession of addressing pain, you’ve got the attention of the new FDA Commissioner, Robert Califf, M.D.

On March 30, 2016, Califf wrote in his first agency blog posting that the agency has an overarching “clear, realistic, and focused sense of priorities, ” with pain and the “present epidemic of opioid overdose” a specific critical issue on his front burner.

The Commissioner writes that the vast of majority of decisions made by the agency are made possible by “a system sustained by professionalism and a well-earned reputation for high-quality and impartial judgments—despite the fact that many decisions must ultimately disappoint (or at least not fully satisfy) one or more constituencies.”

He notes that dramatic advances in biotechnology and information sciences, as well as continuously accelerating trends toward globalization, are ushering in an era of rapid change.

High Quality Evidence

“We must do everything possible to rapidly adapt our national and global systems of evidence generation to meet the challenges and opportunities presented by technological advances. What does this mean? I’ve noticed that when high-quality evidence is available, FDA’s scientific decision making is often straightforward. But it can be particularly challenging for the Agency when it must make scientific decisions in the absence of optimal information. In such cases, opinions may carry greater weight, and there can be an increased likelihood of dissension both inside and outside of FDA, as well as a greater risk that we may fail to most fully protect or advance the welfare of patients and the public.”

He’s especially focused on biomedical science, which he says is nearing a tipping point where the amount of high-quality evidence available to support our decisions is likely to increase exponentially.

Big Data

Big data is also on his radar.

“As a nation, we have invested over $50 billion to provide an electronic health record (EHR) for almost every American. Further, computational storage capacity and analytical power are increasing by orders of magnitude from year to year. At the same time, the advent and wide diffusion of social media are enabling direct communication with patients and consumers on an unprecedented scale. When projects such as Sentinel and the National Medical Device Evaluation System are linked with the many complementary initiatives under way at our sister agencies and at organizations outside of the government, we can (and I believe in short order will!) build a robust foundation for a system in which both private and public sectors can produce much more useful knowledge at a fraction of the cost such efforts have previously required. Indeed, a major function of FDA is to support the continued development of an effective system for evidence generation, so that the private and academic sectors can make it happen.”

The Commissioner is likely a lame-duck, as a new president in 2017 is likely to appoint his or her own choice to the politically appointed job. But the Commissioner’s observations are likely deeply embedded in the agency’s internal bureaucratic agenda and worth taking seriously.