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 agency would focus on the larger virtue of predictability (being able to anticipate FDA’s standards and actions).
The task has proven larger 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 spoken), 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 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 decisionmaking 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 decisionmaking. In the quest to achieve this goal, I believe the glass is half-full.
Steven
Interesting posting, including the remark you made about the short life cycle of medical devices and the difficulty of explaining the difference between a 510(k) and a PMA to someone not well versed in these subjects, not to mention the difference between 510(k)s that do and do not require clinical data.
Also found interesting your remark that “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.” I assume you’re referring to the Menaflex 510(k).
At the risk of sounding cynical, anyone who thinks ReGen Biologics, the sponsor of the Menaflex, is the first company to bring members of Congress into the mix is probably naive. I can’t recount other instances, but I find it difficult to believe this was the first time. On the other hand, the review team on the Menaflex also went “out of bounds,” as it were, on a couple of points. Also, Dan Schultz said in the 510(k) approval doc that ReGen was difficult to deal with.
As for transparency? FDA’s device branch has signaled it may publicize enforcement/compliance action via social media (Twitter, Facebook). An interesting problem for CDRH on this score? It is not even remotely planning to issue a social media guidance. I find that a little conspicuous.
Mark—Thank you for your comments. The most fundamental misunderstanding I encounter is: why are devices not regulated like drugs? I have to explain that even before getting into 510(k), PMA’s and the “often hard to grasp” concept of predicates (in theory and as applied).
I was indeed referring to the ReGen case. The Congressional involvement was egregious, although I will agree it surely wasn’t the first. The key–and the starting point in my mind for the current medical device debate–was FDA’s excellent self-evaluation report in September 2009. My colunm on it is at: http://www.fdamatters.com/?p=528.
The FDA report analyzed the numerous ways in which the ReGen process was irregular, suggested remedial steps, kicked off an ongoing internal review of how to make the review process better, and asked IOM to do their review. User fee negotiations would have forced debate about medical device approvals in any case, but in a sense the debate started more than a year earlier because of Re-Gen and the FDA self-evaluation.
As to social media, FDA doesn’t have a clue–its not just CDRH that is a problem. FDA held its first information hearing on medical products and the Internet in 1998 and has not produced any guidance. More hearings have been held over the years–and again last year, I think. Guidance is promised for late this year, but there have been promises before. I am a big supporter of FDA on a lot of fronts, but they have simply dropped the ball on this one. Steven