FDA Announces Changes to CDRH’s Advisory Committee Process
This past Monday the FDA posted the following statement on the FDA web site;
“The FDA’s Center for Devices and Radiological Health (CDRH) is making several changes to the way it operates expert panels that review and discuss data and information at panel meetings on devices under premarket review.
The number of device panel meetings has risen over the past couple of years. In 2008, there were 10 panel meetings covering 14 major topics. In 2009, there were 17 meetings on 20 topics and 2010 is on track to surpass those numbers.
This increase in activity brings along challenges the agency is addressing through changes to how it operates panel meetings. In addition to staffing issues, the changes, which are effective as of May 1, 2010, will address voting procedures and other issues related to information presentation and flow of discussion.
- ADVISORY COMMITTEE STAFF
CDRH recently centralized the Designated Federal Officers and hired a staff of six, full-time employees. Centralizing the panel staff will provide improved continuity across CDRH.
- ADVISORY COMMITTEE VOTING PROCEDURE
For meetings focusing on a particular device that is under review in the agency to determine its approvability, panel discussion has not always reflected a panel’s final vote on approvability. Under the new approach, instead of voting on the approvability of premarket approval applications, including conditions of approval, the panel will vote on the safety and effectiveness of a device and the device’s risk versus its benefit.
By changing the voting procedure in this way, panel members will address key scientific issues during their discussions, which will be reflected in their votes. This change will also allow panel members to address issues related to their scientific area of expertise instead of regulatory issues, with which they may not be so familiar.
To further simplify the voting process, CDRH will move from a simultaneous show of hands to a ballot vote, implementing an electronic voting procedure. While the votes will be publicly tallied so that panel members can be identified by their vote, the ballot process allows each panel member to cast their vote without immediate influence by other votes.
- PANEL DELIBERATIONS
In order to provide useful information to both the agency and the sponsors and to allow the panel more time to discuss the issues without interruption, CDRH will instruct the panel to provide their scientific opinions and recommendations to the questions posed by the FDA without interruption. There will be an hour for panel deliberations, during which the panel may ask questions of both the sponsor and the FDA. We believe focusing the amount of time the sponsor may respond to questions to the panel will allow for a more robust discussion among the experts and provide CDRH with information needed to reach a decision regarding the issue before the panel.
- CDRH PRESENTATIONS
In the past, CDRH reviewers presented a unified, consensus analysis of supporting data. Now, reviewers will present together with data and analysis, the range of scientific opinion amongst the group. By taking a broader view of the data that is supplied and the opinions of different reviewers and offices within CDRH we will provide the panel the ability to have a more in-depth discussion on safety and effectiveness and risk versus benefit of the device at issue.” (Highlighting added by Diabetic Investor)
It is this last statement that intrigues Diabetic Investor. Some would argue that a unified, consensus analysis of supporting data speeds up the process. This new approach may bring a greater number of opinions into the mix but could ultimately become overly confusing. For example consider how these new rules might apply when a closed-loop insulin delivery system comes before the FDA, something that surly will require a panel review. Given all the elements that make up this type of system the panel would likely include members from a wide variety of disciplines.
While Diabetic Investor favors vigorous debate and agrees that consensus building could stifle dissenting views, it’s equally true that too many opinions can overly confuse the agency. As the old saying goes; “Too many cooks can spoil the broth.” Having attended several of these panel meetings Diabetic Investor agrees with something Judy Sproles once stated; “If there is an opinion, facts will be found to support it.” How many times have we seen a group of experts look at the same data set and come to very different conclusions.
Getting back to what a panel on an artificial pancreas might look it; Diabetic Investor can only imagine the wide disparity of views. Let’s assume for a moment that after all these views are heard both pro and con, and the issue is to put to vote. What happens if the vote is split down the middle or comes out 10 to 9 in favor? How then does the agency proceed? Can the agency confidently approve such a product with a simple majority vote?
Diabetic Investor also wonders how forthcoming panel members would be to provide dissenting viewpoints in a public forum. Given the nature of these panels several of the experts on the panel are dependent on the companies who make these devices. It’s one thing to have a dissenting view while forming a consensus; it’s a whole different animal to have the guts to express this dissenting view in a public forum in front of the very people who may be paying for your research or possibly employing you in the future.
Looking over these new rules it obvious the agency is striving for greater transparency. The real question is will transparency really improve the process or will it just slow down the whole process. Frankly the real winners here are the companies with devices already on the market. The way things are going it won’t be long before the FDA besides looking at “safety and effectiveness of a device and the device’s risk versus its benefit”, they add in a cost/benefit analysis. Given that we have nearly 50 different glucose monitors on the market that all do basically the same thing this may not necessarily be a bad idea. Is it really necessary to give the patient a choice between 10 different insulin pumps?
At last week’s AACE there was a great deal of discussion on developing a set of standards for treating patients with diabetes. The general consensus was that standards are fine as long as the physician can adopt them to suit the individual patient. Looking over various studies an argument can be made that there are certain patients where tight glycemic control can do greater harm than good. In situations such as these any standards developed would have to flexible to accommodate this segment of the patient population. If there is one thing everyone seems to agree on is there is no silver bullet or one-size fits all approach to battling diabetes.
However in the device world it is much easier to develop a set of standards as these devices perform a specific function, such as delivering insulin or monitoring glucose levels. At minimum the FDA would be wise to consider developing clearer and stricter standards for these devices so they are not wasting their time and our money looking at a device that offers no compelling benefit to the patient. This would also help panel members as they would have something to judge the device against.
Diabetic Investor believes it would be equally wise for the FDA to look beyond how the device functions and the role the company has in training patients how to properly use the device. This is particularly true in the insulin pump area, where proper patient training can mean the difference between life and death. There are times in this market where the companies who make insulin pumps seem to forget that there is a real live person attached to their product, not a robot or computer, a person who needs to understand that it’s not exactly a good idea to prime the pump while it’s attached to the body.
The reality here is the FDA, for both drugs and devices, is becoming exceedingly cautious and overtly politicized. This drive for greater transparency; allowing every opinion to be heard no matter how off the wall to be heard, will merely slow down an already slow process. The fact is the FDA does not want to deal with real issue of developing clearer, stricter standards. Instead the agency is doing what they do best looking for another way to pass the buck and ultimately making harder on themselves. Clearer and stricter standards would also benefit the device industry as at minimum these standards would provide a road map when developing new devices.
The fact is the FDA being part of large and complex bureaucracy we call the Federal government is doing what bureaucracies do best; creating more obstacles to progress. Or as Laurence J Peter and Raymond Hull wrote; “Bureaucracy defends the status quo long past the time when the quo has lost it status.”
