With all of the exposure that FDA inspections and the 510(k) process have been getting, many companies may not be aware of the increase in device approvals that go before the FDA Advisory Committee.  The number of annual Advisory Committee meetings for all drug and device related matters has almost doubled since 2006.  Most regulatory and quality professionals are used to answering  questions about their premarket approval application (PMA) when they come from FDA reviewers.  However, once the matter is brought before an Advisory Committee, the game changes and the stakes are much higher.  At a recent industry webinar, device makers were given some very useful insight and advice on handling the FDA Advisory Committee.

The Advisory Committee Meetings are a good and necessary practice in principle.  The FDA uses these committees to seek independent, expert advice on newly discovered matters of scientific significance.  Dialogue is meant to be open, candid, and free-flowing on all sides.  However, many times in practice these meetings start as a civil debate over scientific matters, only to deteriorate into a mix political and personal agendas.  Negative bias can be especially expected if a sponsor did not follow FDA’s advice on clinical assessments or the overall development program.  The process works best when all stakeholders are well prepared, and send clear, consistent messages.

When devices are reviewed in committee, CDRH tends to look at how the product will fit into actual clinical practice, and more recently, off-label use is being considered.  Sponsors will need to be sure to address these issues early in the process.  In addition, all pertinent information regarding product risks should be fully disclosed right upfront.  Considering the average reviewer only has a limited number of hours to prepare, the Briefing Book and the presentation should be scripted such that the FDA committee members can quickly focus on the most critical and compelling factors during the review.  The meeting should be approached as forum to gain consensus about the science behind the device being submitted.   The degree to which sponsors are sucessful at this process depends on how well they are able to:

1. Understand the Committee (audience)
2. Maintain clear messages througout the presentation
3. Prepare for meeting (Practice, Practice, Practice)
4. Learn from those with past Committee experience

If you have not had to face an Advisory Committee yet in your career, chances are you will soon.  If you have already been in this arena once before, please feel free to add some “lessons learned” in the comments section.  We need to work together as an industry to ensure that all stakeholders in the Advisory Committee process can work towards a meaningful and transparent discussion that protects the health and safety of patients, while providing a pathway to delivering the therapies they so greatly need.