Advisory committee meetings are the modern regulatory equivalent of a three-ring circus: lots of participants, lots of media attention, professionals at the center of attention and the lingering possibility of something going very wrong-especially if you're the company whose product is being considered.
So how do you keep your product out of the mouth of the lion or from falling off the trapeze rings? It's not easy, but there are a number of strategies you can adopt to help you make the advisory committee process a little bit easier, said one expert at the 2013 Advamed conference on 23 September 2013.
In his presentation, Michael Morton, vice president of Global Regulatory Affairs for Medtronic, explained that there are myriad risks inherent in every advisory committee meeting. It's typically the first public forum at which people will hear anything about your product and its supporting data, it's open to members of the public and your competitors, widely reported on in the press and monitored by investors, and heavily scrutinized by FDA regulators.
While the final advisory committee recommendation isn't binding on FDA, the agency's regulators often adopt or closely mirror its conclusions, meaning the stakes at the meetings are enormously high.
So what's a regulatory professional charged with preparing for an advisory committee meeting to do?
Morton's presentation contained a number of recommendations:
Make sure your regulatory strategies and processes are scalable.
Morton starts off by stating the obvious: Preparing for a panel is a lot of work. "Typically, you're going to have a team of no more than six people who will be actual experts in the data, and who will be carrying the burden on this." This means that if they're already involved in reviewing the PMA, "this work can overwhelm them very quickly." The important part is to realize which processes will require additional resources, and then plan for that accordingly, he said.
Assign roles and responsibilities early, and make sure the team doesn't lose focus
"The panel becomes a very exciting thing. Everyone wants to get involved, but not everyone knows what to do," Morton said. "You don't want a room of people sitting around not contributing." Or, worse, a team so large that it lacks accountability, concentrated expertise or a unified vision. As the saying goes, too many cooks in the kitchen ruins the food.
Recognize your limitations and seek outside help if needed
Morton said recognizing the first point, companies should be prepared to seek outside help, either from partners or consultants or even additional staff. There are vendors who will help organize slides, help with public affairs, manage projects, consult on the panel process, and describe the personalities of FDA staff. That's one less burden for a company to deal with, Morton said. "I would encourage you to consider these vendors carefully," he said, noting that it's important that a vendor be in sync with the needs of the company.
Practice, practice, practice
It will be useful to practice going before mock panels prior to the real deal, Morton said. Many companies use expert consultants and third-party contractors to mock up a panel to help their employees prepare in the hopes that the real panel will go more smoothly. And once the big day arrives, it's often useful to have a preparation room set up close to FDA's meeting room, as well as a media room to respond to inquiries after the panel.
Budget for the meeting, both in time and resources
These meetings can become very expensive, very quickly. If a company knows early on that it will need a panel, that gives it more time to prepare-and more time for expenses to add up for preparation. Conversely, if a company only learns late in the review process that a panel will be required, that's less time for expenses to accumulate, but the costs associated with urgent execution of planning goes up exponentially.
Understand FDA's position, including areas of alignment and non-alignment
Disagreements happen. The important part is when you find yourself on the opposite side of an opinion from FDA, "You need to be respectful toward the reviewer's opinion," Morton said. State the difference of opinion and explain why you arrived at that conclusion, but don't escalate it into something that could undermine your standing or credibility in front of the panel.
Understand the arguments against your product and the data used to support it
As anyone who has ever debated someone before can attest, the quickest way to lose a debate is to not anticipate the arguments your opponent is going to make. And while an advisory committee meeting isn't inherently adversarial, the tide against a company can turn quickly if it doesn't have adequate or sufficiently explained answers to the panelists' or regulators' questions. Know the strengths and weaknesses of your data, as well as the limitations of what the data show. "What I always say is 'remember the low-hanging fruit,'" Morton said. This means making sure the data in the presented tables add up and other seemingly minor details that could escape through the editorial process. Lapses here can harm the broader credibility of your data.
Stay within your allotted time
"Respond quickly," Morton says. It's important to address questions as directly and efficiently as possible. Laboring over a question can take up valuable time that could be spent addressing the concerns of panelists and, worse, could lead to panelists believing you don't have a good answer for a question.
Understand the acceptable protocol for interacting with the panel
Two rules reign supreme, Morton said: Be respectful of the panel, and don't go interact with the panel either before or during the advisory committee meeting.
Make sure participants on your team "own" particular segments of a topic
"You want to be really prepared; you don't want to look like a pan of popcorn when you get a question," Morton says, evoking the imagery of a jumping, skittish mass of kernels. "You don't want your investigators jumping up to the microphone and expressing their differences of opinion. It's a bad, bad time for that to happen." Instead, each company member should "own" a particular topic, and know immediately whether or not a question from the panel is capable of being answered by them. Further, all company members' answers should be consistent with those expressed by their colleagues.
Things could get ugly
One of the hallmarks of advisory committees is the open public hearing, during which people can bring up their own interpretations of the data. "Be prepared for some extremely adversarial comments to come from [members of the audience]," Morton recommended. "Have your team briefed and ready to sit through that."
Prepare a concise closing statement to summarize your argument
A closing statement will help cement your broader points in the minds of regulators, leaving them with a takeaway message right before they vote on the key questions before the panel.