The journey of getting a medical device to market can be long and arduous, but ultimately rewarding. Throughout the process, there are many roving pieces that, if left unaccounted for, could halt a novel device in its tracks.
One key stepping stone on the path to approval is the FDA Advisory Committee meeting (ADCOM). For companies not familiar with ADCOM meetings, CTA sits down with Jennifer Bolton, a regulatory fellow at Boston Scientific, to explain all.
As an experienced professional, Bolton has in the past worked on a left-atrial appendage closure (LAAC) device. Having taken seven years, two PMAs, and three ADCOM meetings to approve, this novel product is the only approved LAAC device across the U.S.
In this Industry Viewpoint, Bolton sits down with CTA Editor Henry Kerali to explain the steps required to best prepare for an ADCOM meeting.
Henry Kerali: What are FDA advisory committee meetings and what function do they serve?
Jennifer Bolton: An FDA Advisory Committee is a group of physicians whose intent is to advise the FDA on difficult matters in a public, transparent forum. The panel also includes three non-voting reps – one industry representative, one patient representative, and one who represents the consumer.
On an advisory panel, all panel members can ask questions, regardless of whether they’re voting or non-voting members. At the conclusion of a panel meeting, the physicians vote on the FDA’s questions. After the vote, the voting members state why they voted as they did.
It’s important that meetings between the FDA and the trial sponsor are public, as clinical data aren’t always transparent and easy to understand. Occasionally, the FDA will call a private panel meeting that is not open to the public on various topics. However, meetings that review clinical data for a premarket approval (PMA) are almost always a public forum.
Furthermore, the FDA may give homework assignments to the panel whenever it seeks clarification on certain issues. In this instance, the panel would provide additional advice on what the FDA should do. Whereas the FDA doesn’t necessarily have to follow the ADCOM’s advice, they certainly factor it into consideration when they finalize a decision, based on the clinical data.
HK: What have been your experiences in dealing with the FDA panel?
JB: I have been involved in two panel meetings in Dec 2013 and Oct 2014 – both involving the same product for the same indication, which is unusual. Most of the time, if a product goes to panel more than once, it’s for a different indication.
The typical process involves the FDA requesting a panel for a device. Depending on what the data looks like, the FDA may choose to call a panel meeting on a certain product in order to have a discussion transparently in the public eye, whether because it’s a novel device or due to clinical results. Oftentimes, sponsors may approach the FDA asking whether their submission requires a panel meeting, and typically FDA will respond saying it depends on what the data looks like. FDA will make the final decision regarding if a panel is needed only after reviewing the data.
So when does the FDA make that assessment? When the sponsor submits their PMA, it can request to have a 100-day meeting. If the FDA doesn’t have many queries and feels it’s straightforward, a conference call may be set up in lieu of a 100-day meeting. Regardless of having a formal meeting or not, 100 days after PMA submission is the approximate timeframe for the FDA to determine whether your PMA will require a panel meeting.
HK: What advice would you give to sponsor companies that are yet to engage with the FDA?
JB: If they haven’t engaged with the FDA, sponsors are advised to reach out early. The FDA’s mantra is: Come early, come often. Sponsors should use the pre-submission process to have meetings and discussions with the FDA at every opportunity, especially when they’re designing the clinical study. Transparency between the sponsor and the FDA during the study design phase is crucial in obtaining the data the FDA will need to approve the product.
Furthermore, if sponsors are submitting data from a trial conducted outside the U.S., they must liaise with the FDA early. For the PMA, sponsors should setup a pre-PMA meeting with the FDA to ensure everyone’s aligned with what’s required. Thereafter, request a 100-day meeting, bearing in mind one may not be necessary, depending on the product and the data in question.
In my experience, the FDA review team has always been very good about being transparent and having a discussion regarding any questions. We will frequently have discussions with the FDA. If FDA is in agreement with our response plans, we can provide that in a submission. If they say no, we can then have further discussions to have a better understanding of what the FDA is looking for and determine how to collect that data. These meetings are critical to ensuring success.
HK: What best practices should sponsors adopt to prepare for a committee meeting?
JB: Determine who in your company needs to be involved in preparing for the panel. I recommend reserving a conference room where everyone converges and brainstorms the kind of questions the FDA panel could ask. Many times we would practice presentations or pulling up slides to answer questions, which allowed us to prepare accordingly. Additionally, make sure your team thoroughly understands your data. It’s important the data are presented in such a way that’s not confusing or open to interpretation. If anything’s unclear, be sure to have the right people available with answers ready to resolve any potential issues.
Ultimately, what’s key is to practice, practice, practice! It’s important that each team member is well-prepared and ready for whatever questions may come their way. Hire a good panel prep consultant company –as they are proficient at training presenters. What’s even more important is to have access to their technology that enables you to pull up slides quickly during a Q&A. Panel members are so accustomed to this speed during a meeting that I’m afraid a company not using current technology would appear slow and not as well prepared.
Also, be sure to proactively reach out to the industry representative (IR). The IR is the only panel member the sponsor can work with prior to the panel meeting. You want to ensure that the IR has a thorough understanding of your data and is therefore prepared to ask question if it appears that other panel members misunderstand any key points.
Overall, it’s important to note that it’s a minority of PMA submissions that require an ADCOM meeting. Since panels happen on a less frequent basis, I think people aren’t always knowledgeable on how to prepare for them. How well your data is presented at an FDA ADCOM meeting, and how well it’s understood, is incredibly important for the outcome of that meeting, and ultimately how it will impact your device approval.