Unpredictability
The final reason for fewer panel meetings, according to Stiegman, is that organizing a panel is not only a lot of work and costly for the FDA, it can also be risky. “FDA will bring a device to panel to seek specific questions to be answered, in addition, to the safety, effectiveness, and risk/benefit questions. There is a risk of the panel not addressing FDA’s device specific questions, which brought this device to panel in the first place.”
Stiegman has prepared for Advisory Panels on both the FDA side and the company side. “It is a long and arduous task to prepare for a panel meeting.”
In general, Stiegman says companies often do not want to bring their device to a panel because of the unpredictable nature of panels and their discussions.
The FDA also has other options.
“In an already short-staffed and busy review team, FDA may want to look at other options to get their questions answered instead of a public Advisory Panel such as Panel Homework Assignment.”
“Scientifically and clinically, FDA and review team have to weigh the value of the panel input on any questions, how panel’s input would affect their overall decision, and ultimately, the overall benefit compared to the risks associated with preparing a panel.
“In some cases, where a device may have a safety concern or may not have met their success criteria, FDA may use a panel to justify an approval or justify a disapproval. However, in many cases, these scenarios have precedent, where the safety and effectiveness can be determined using the totality of information for similar devices, as well as, the benefit risk profile being evident.”
In general, the decision of FDA to take a device to an Advisory Panel, according to Stiegman, is complex and sometimes difficult given the number of factors with no true straight-forward formula to help in this decision.
“The combination of all three of these scenarios culminate into Advisory Panels seemingly looking like a dying breed.”
Innovation Renaissance?
However, Stiegman and his team at MCRA have seen a turn in innovation, with new technologies, materials, and patient treatments being discussed with the FDA.
The team is seeing more and more devices that represent a “first-of-kind device, and FDA wants to be careful that they understand the ramification of their approvals, as to not set a damaging precedent with how an innovative class of devices is regulated. There a sense of hope that the excitement and intrigue of Advisory Panels will once again return to a Gaithersburg Hilton near you.”
If Stiegman is right, we should all be getting out our good clothes and get ready for another Happening. The post-Great Recession innovations should be exciting.
