FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote.
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Not surprisingly, investors highly scrutinize these proceedings and stock markets react accordingly. For these reasons, it is critical for companies to have a clear understanding of FDA’s thinking related to these meetings.
FDA’s approach to advisory committee meetings has been evolving in recent years, including questioning the very necessity of these meetings, the timing of these meetings, and most recently the format of these meetings.
FDA has been Convening Fewer Advisory Committee Meetings
According to 21 U.S.C. §355(s), FDA is required to hold an advisory committee meeting prior to approving a drug if no active ingredient of that drug has already been approved. Alternatively, if FDA chooses not to hold an advisory committee meeting, they are mandated to explain in the action letter (e.g., an approval letter or complete response letter) why the agency did not do so:
Prior to the approval of a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 262 of title 42, the Secretary shall—
(1) refer such drug to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee; or
(2) if the Secretary does not refer such a drug to a Food and Drug Administration advisory committee prior to the approval of the drug, provide in the action letter on the application for the drug a summary of the reasons why the Secretary did not refer the drug to an advisory committee prior to approval.
However, over the past two years, FDA has convened fewer advisory committee meetings than in the past, and now regularly indicates in action letters that the application “was not referred to an FDA advisory committee because the evaluation of the application did not raise significant safety or efficacy issues that were unexpected in the intended population”.
This is a double-edged sword. On the one hand, if your novel drug has promising efficacy and safety data, then not having to make the case before an advisory committee meeting saves considerable effort and time. On the other hand, if your product does not have strong data and you think an advisory committee meeting would offer an opportunity to appeal to the unmet need and clinical impact of the product, then being granted a meeting might be beneficial. Unfortunately, advisory committee meetings are only called at FDA’s discretion.
Timing of Advisory Committee Meetings has become Unpredictable
In the past 2 years, our clients have received widely varying notice of an upcoming advisory committee meeting. Some clients have received 6-8 months’ notice prior to the date of the meeting, while others have received as little as 2 months’ notice (in our experience, the average notice has beenon the shorter side). FDA has, in general, been reserving the right to hold an advisory committee meeting and exercising that right unpredictably and on short notice. Not surprisingly, this trend has been exacerbated in recent times due to the SARS-CoV-2 pandemic.
Based on this experience, we recommend that if an advisory meeting is a possibility during your drug review process — no matter how seemingly remote — you should consider engaging a vendor and beginning the planning process to understand what is required. This effort is never wasted, even if an advisory committee is not convened, as the work can often be repurposed (at least partially) to other market approval applications, publications, or marketing messages.
SARS-CoV-2 has Disrupted the Format of Advisory Committee Meetings
If nothing else, SARS-CoV-2 has certainly disrupted the FDA Advisory Committee Meeting Calendar. The first series of meetings dealing with drug development since the pandemic and lockdown began was held just last week after nearly a dozen postponements and cancellations. And the meetings were virtual. While these meetings weren’t about approval (the focus was pediatric oncology development programs), sponsors did have to prepare briefing books, present slides, answer questions, and pull backup slides all through Adobe Connect.
It is unclear how long the virtual nature of advisory committee meetings will persist, and whether FDA might not decide to reduce costs by continuing to hold meetings in this manner as needed. Therefore, preparing for a virtual advisory committee meeting is now also a consideration when submitting a drug application.
ISS has two decades of experience in developing regulatory strategies including support for FDA advisory committee meetings. We are involved in more meetings per year than even the largest pharmaceutical companies and have developed and are now using with clients a process to prepare for virtual advisory committee meetings. For more information on how ISS can help you prepare for your next meeting, contact email@example.com.
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us