In the last few years the ortho panel meeting has gone radio silent.
In 2010 there were nine panel meetings, in 2017 there were only two. In 2018 and 2019 there was not a single premarket approval application (PMA) advisory panel meeting.
We asked the FDA why there were no meetings. More radio silence.
What Do Ortho Panel Meeting Do?
For presenters, sponsoring companies and, indeed, the entire orthopedic community of physicians and companies, the ortho panel meeting is a fascinating process.
Companies submitting their PMAs spend months choreographing every word and speaker. FDA staffers look for the weakest link in the company’s proposal and panel members prepare to perform in front of the public, their peers and industry.
The day of the meeting is like walking into a wedding. In the first couple of rows on the right sit FDA staffers. You’ll know them by their youth, full heads of hair and color in their clothing.
In the front couple of rows on the left sit company representatives and their bevy of staffers and expert consultants. You’ll know them by their maturity, gray or balding heads and conservative clothing.
At the altar sit the wise ones. Listening to the presentations, asking questions and challenging presenters and each other over scientific details and nuances.
Over the next two days there will be public presentations by the sponsoring company, FDA staffers and members of the public. Every speaker will give their reasons why this particular device should or should not be deemed safe and effective.
Lives Changed, Fortunes Won and Lost
At the end of the second day lives will be changed and fortunes will be decided as panel members from prestigious teaching hospitals, clinics and universities vote on whether they will give their support to the FDA for commercializing a new device.
During breaks, panel members are sequestered and under strict orders to speak to no one about any of the presentations. Company presenters retreat to their suite to evaluate what they’ve heard and prepare for the next round. Everybody else spreads out over the Hilton in Gaithersburg, Virginia, and gets into mosh pits of conjecture, second-guessing and predicting how Dr. X on the right-hand side of the panel tables will vote.
It’s a cauldron of science, politics, business policy and media schmoozing. It’s a place where government, business, the public and scientists meet to figure out the latest measure of safety and effectiveness.
So why have there been no meetings?
Are there fewer first-of-kind devices? Is the FDA staff more comfortable in analyzing and regulating these devices? Is the risk of an unpredictable panel meeting too great for both parties?
Former Chief of the Orthopedic Devices Branch at the Food and Drug Administration, Glenn Stiegman, says based on the devices he’s recently seen approved by the FDA, the answer to those questions is—all of the above.
