When pursuing the approval of a new drug or device, you run the risk of being handed an extra hoop to jump through: The Advisory Committee meeting.
Commonly referred to as “adcoms,” the FDA's Advisory Committees are designed to provide independent expert advice to augment the agency’s decision-making process. You are most likely to face an adcom if your application is controversial in any way, or nuanced, or involves cutting-edge technology. Based on your meeting, the adcom members will recommend approval or disapproval of your marketing application.
The FDA generally follows adcom recommendations, so it's vital that sponsors ace the adcom meeting.
What does an Advisory Committee Meeting look like?
Adcom meetings vary widely, but often they are long and intense. You might spend as much as two days before the committee. Sometimes the meetings focus on one key topic; sometimes they are wide ranging. The individuals involved can vary widely, too. There will definitely be subject matter experts representing the FDA, but the public may be represented as well. You might encounter patients, family members of patients, and representatives from advocacy groups in addition to M.D.s and PhDs.
How to prepare for an Advisory Committee Meeting
Proper preparation for an adcom meeting requires time, money, and a large team. Typically those resources must be planned for and engaged before you are even certain that you will be requested to present to an adcom. So, at the outset, you must assess your risk: How controversial is your application? Will the FDA and its scientific reviewers be comfortable reviewing it? Or, are they likely to turn to an adcom? If you have any doubt, invest in the preparation. Here’s how you might begin:
Look at recent history.
Start by assessing the environment: What adcom meetings have taken place in your space before? What can you glean from them? Are there any summary bases of approvals you can review?
You can also learn from adcoms that are not in your area. Watch one or two, if possible. They will clue you into the process. Track adcom activity here.
Learn who’s on the committee.
Get familiar with the individuals on the relevant adcom. What have they published? What are their opinions? Are they for or against what you are bringing to the table?
Round up your experts- and prep them well.
Preparing to appear before an adcom is probably one of the more intense exercises that anyone will ever go through as a subject matter expert or regulatory person. Your team must be thoroughly prepared to deftly answer any possible question. It is also important that team members be polished speakers/presenters — professionals who can potentially endure hours of high-level questioning. If your subject matter experts are not good speakers, be candid and secure speaker training for them.
Practice, practice, practice.
It is not possible to over-prepare for an adcom meeting. Study a lot, meet often, and secure professional coaching if at all possible. A consultant who has been through it all before is an invaluable asset to your team at this time.
Insist that preparation is necessary.
You may well find that your key subject matter experts are busy working on many important tasks. The last thing they want to hear is that they need to make time for adcom meeting preparations — or be coached in public speaking. But, they do. In fact, adcom meeting prep might be the most important of all the tasks on their to-do list.
Consult with experts.
If there might be an adcom meeting in your future, know that you can get the expert guidance you need to properly prepare from the team at The Bracken Group. We’ve been there.