If you’re a sponsor going before an FDA Advisory Committee (ADCOM), the most important people in the room are the ADCOM members who will play a major part in deciding the fate of your drug or device. Over the past two years, the FDA has followed ADCOM recommendations regarding product approval approximately 87% of the time.
Since an ADCOM is staffed with people of various expertise, levels of experience, and interests, your team must be prepared to answer a wide range of questions to convince the ADCOM to recommend approval. In preparing for such a unique and challenging meeting, you’ll need to hold mock rehearsals. Below are some tips to maximize mock meetings.
- Know your audience and consider their backgrounds and preparation. It’s important to remember that you’re not presenting to the FDA. Rather, you’re presenting to a committee who has not seen your entire application. They may spend limited time reviewing briefing documents and but will come into the meeting with unique perspectives and interests. Your presentation of data (in the briefing document, core presentation, and Q&A) must address the concerns of this specific audience.
- Avoid falling into the trap of staffing your mock panel with product experts, those familiar with the drug, or even those who participated in the drug’s development. These experts don’t usually represent the various backgrounds of the actual ADCOM members. Instead, recruit mock members who reflect the actual committee so that you can simulate a realistic meeting experience. This will help you capture the most accurate questions, even those that are challenging or obscure, and get relevant advice on the best direction for your core presentation and briefing document.
- Consider having a statistician for most, if not all, mocks. Keep in mind that all ADCOMs will include at least one statistician. If there is not a statistician on your ADCOM, recruit one.
- Remember to have representation for temporary voting members at your mocks. The FDA may call in temporary voting members to your ADCOM who may possess areas of expertise specific to the drug, device, or related issues. The agency does not make these names public until two business days prior to an ADCOM meeting, so it will require you to predict the type of experts who will sit on your panel. For example, if the FDA is concerned about excess cardiovascular risk with your product, but you are going to an oncologic drug ADCOM, they may bring in a cardiovascular specialist as a temporary voting member for your meeting. Or if your product is going for a pediatric indication but no sitting committee members have pediatric expertise, one or more may be brought in as temporary voting members.
- Consider adding mock members to represent nonvoting members. All CBER and CDER Advisory Committees staff a voting consumer representative. CDRH staffs a nonvoting consumer representative and a nonvoting patient representative. A nonvoting industry representative is also present at all panels. While these members may not vote, it’s important to realize that they all have a voice during Q&A and deliberations.
- Have multiple smaller mocks with six to ten advisors rather than one large mock meeting. This will allow you to test, revise, and retest your core strategy, briefing document, and Q&A.
Following these steps will ensure a more realistic mock rehearsal. In this way, your team will be able to understand committee members’ values and beliefs; predict questions or challenges; proactively address key perceptions; and advance your core presentation, briefing document, and Q&A development. Ultimately, this “perfect practice” will result in a team that is ready to face the challenges on ADCOM meeting day.