More than two years ago, FDA Matters suggested that one of FDA Commissioner Hamburg’s goals would be making it easier for stakeholders to anticipate agency actions. I was looking beyond transparency (see what FDA is doing and has done). I hoped the FDA would focus on the larger virtue of predictability (being able to anticipate FDA’s standards and actions).
The task has proven larger and more complicated than I imagined and the volume of issues facing the agency has made progress hard. However, the agency has taken many steps forward, even as it has been pushed backward on a number of occasions. Is the glass half empty or half full?
I believed that, after the initial stage of setting new policies and assembling her team, one of Dr. Hamburg’s priorities would be to provide more guidance (published and otherwise), explain more actions, and rationalize and coordinate more regulatory processes. With regard to this goal of predictable, science-based regulation, progress has definitely been made.
Once completed and enacted, the 2012 round of user fee legislation will further contribute a degree of predictability. The five-year renewal cycle allows industry and FDA to re-work ground rules for the product review process (note: these negotiations are intended to change process, not standards).
So why doesn’t it feel like FDA is making more progress in becoming predictable and science-based in its regulatory decisionsmaking?
First, a degree of uncertainty is inherent in the nature of FDA’s work. I’ve explored this theme in two recent columns. One discussed the role of FDA staff and the necessity that People, Not Science, Make Decisions. The other examined the biological complexity that makes it impossible to provide guidance that anticipates all situations and outcomes (FDA Approvals and the Failure of the “Human Body as Machine” Metaphor
Second, certain well-publicized areas of conflict between FDA and industry have tended to grossly exaggerate the overall degree of unpredictability. For example, FDA faced a decision last year on three weight-loss drugs—and approved none, despite credible claims that the drugs met FDA standards. The agency’s reasons satisfied some observers, but not others. This particular situation became something of a poster-child for critics who say that FDA is unpredictable in its decisionmaking.
The ongoing struggle between FDA and the medical device industry has also focused attention on claims that FDA’s regulatory decisions are not predictable. I have chronicled the often-heated debate in a number of columns, most recently Medical Device Melodrama: A Great Story With a New Plot Twist.
Medical devices were a conflict waiting to happen. It is not because FDA is disinterested in improving predictability in this area. Rather, the approval process is uniquely adapted to the nature of medical devices (wide range of risks, short innovation cycle for product improvements) and almost impossible to explain to someone not already familiar with medical device regulation. Ironically, the two years spent (thus far) on improving the medical device process began with FDA unexpectedly approving a device based on irregular agency procedures.
Increasing predictability and science-based decision-making are still hallmarks of Dr. Hamburg’s agenda. A recent example is FDA’s new initiative to spur biomedical innovation and improve the health of Americans. Streamlining and reforming FDA regulation is one of the initiative’s goals.
If FDA has not become more predictable in your area of interest, keep encouraging FDA to make it so. The agency is listening and making progress. They need feedback on where processes have broken down or do not produce predictable decision-making. In the quest to achieve this goal, I believe the glass is half-full.
adapted and republished with permission from FDA Matters