I've attended more FDA advisory committee hearings than most and believe I have a decent grasp of how those hearings should go. It's true I'm no expert, but recent hearings for medical devices have gone in a direction that strikes me as odd.
For instance, at the Jan. 11 meeting of the gastroenterology/urology devices committee, FDA's Herb Lerner, MD, addressed post-market study requirements for an application filed by Torax Medical of St. Paul, Minnesota. Among the items of discussion that day were quality-of-life scores for gastroesophageal reflux and measures of esophageal pH.
Lerner said: “This is a very interesting question in that it would sort of lead to a discussion of what if another device came down the pike, would this be enough for the next device to come in? Would this be enough for us to go ahead with a trial?” You can find the transcript here.
Even if regulations do not forbid such things, the ethic at advisory panels has always been that the panel is to consider that specific application with no regard for things that may “come down the pike.” Lerner told me afterward his query was strictly “exploratory,” but it seemed as though he was asking the panel members to make a decision based largely on future applications. Am I reading too much into it?
Another example occurred at the advisory hearing dealing with the regulatory status of cranial electrotherapy stimulator (CES) units. As I wrote in the Feb. 14 edition of Medical Device Daily, the Feb. 10 hearing “was conspicuous for two events.” At the conclusion of the hearing, a member of the audience approached the podium after the vote and criticized the panel's decision, but FDA staff instructed the audio team to kill the microphone before Les Hamilton of Silver Spring, Maryland, made his views known.
FDA seemed less concerned when panelist Murray Stein, MD, of the University of California San Diego (San Diego) left the room to call someone he knows the National Intrepid Center of Excellence (NICoE) at the Walter Reed Army Hospital to rebut a claim that NICoE uses CES systems.
Stein claimed his contact said the center has never used CES systems, but his statement was contradicted by several in the audience who were not allowed to respond, including Stephen Xenakis, MD, a retired U.S. Army brigadier general. Xenakis told me in an interview, “I know it's used at NICoE because I've talked to them about setting up projects” associated with such devices. I also contacted NICoE and public affairs officer Joshua Stueve confirmed the device is indeed in use there.
My impression in this case is that FDA allowed Stein to do something a sponsor could never get away with and provided the panel with information that is just plain wrong, but I get it if nobody cares what I think. I have no skin in this game and I'm no expert.
Just out of curiosity, though, does anyone see a problem?