During FDA Advisory Committee meetings, there is an Open Public Comment period that is scheduled to permit concerned members of the public to comment on the issues before the advisory committee. Those who sign up are asked, in the interests of transparency, to state whether or not they have received funding from any party in order to attend the meeting to offer comment or whether they receive financial support from a party who is in any way connected with the issue at hand.
Many times, no one shows up for the Open Public Comment period. Many times, special interest groups offer a consistent skepticism. Sometimes, competing interests even use this venue for the opportunity to offer a commercial for their own product. Many times, it is just a patient who wants and needs to be heard.
But whether or not people offer public comment should be weighed and there are considerations to ponder.
Usually the objective is to demonstrate to the panel a need for the product.
In that case, consider that it is important to remember that the people sitting on the advisory panel are experts in their field. If the treatment is not first-in-class, then demonstrating the need for the candidate treatment is only strongly desirable if the new treatment offers some new benefit – i.e., lower adverse event profile or ease of use.
Or, the desire may be to draw attention to the condition which the treatment addresses.
Again, these panelists are also treating physicians. If the condition is one that they see every day in their practice, taking their time to explain a condition that they already know very well may not be supportive and may even be counterproductive. In this case, testimony ideally highlights either a condition that is rarely seen, so that there is a human face put into the mix of considerations or demonstrates a nuance that is rarely considered.
A definite non-starter, one which I have seen that backfired tremendously, is where a competitor sends public comment to detract, with the person offering testimony refusing to state who paid the expenses for their appearance.
Public comment is important, as seen when many people showed up to testify during the Plan B OTC switch meeting, a public comment period that lasted nearly 3 hours, or during the recent ADHD labeling meeting. Sometimes, even members of Congress have shown up, though I would never recommend it.
The bottom line is that patients and third party groups are great advocates, or sometimes detractors. But the committee is basing their decision on the science and the data. The ability of anyone to sway their opinion during Open Public Comment is the exception, not the rule. It is dependent on a variety of circumstances, and that is why it should be evaluated on a case by case basis.
