Regulatory Open Forum

You are making a presentation to the senior management team.  You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a similar device cleared in 90 days."

How should you respond, and what can you do to prevent this situation from occurring in the future?

I would respond by explaining the assumptions I used to calculate the number of days to clearance.  FDA review time is 90 days, so why was 120 days stated for clearance?   Be truthful about your assumptions. Did the timing include file preparation and submission time after data or some other timing that is within the companies control?  

In the future, I would include a list of assumptions in the slide presentation, either up front or as a back-up slide.  

You are making a presentation to the senior management team.  You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a similar device cleared in 90 days."

How should you respond, and what can you do to prevent this situation from occurring in the future?

You are making a presentation to the senior management team.  You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a similar device cleared in 90 days."

How should you respond, and what can you do to prevent this situation from occurring in the future?

Hi Nancy,

Obviously this is one of those situations that regulatory folks deal with probably every day so it is a timely discussion just in general.

To me, the first thing is not to "argue" your case - especially in front of senior leadership.  I would start during the meeting with a response that the targets FDA has for clearance are 120 days.  While some devices might be a bit more straight-forward and receive more rapid approval, the plan should account for the timing that the FDA has put in place in their commitments under the user fee requirements.  That way we aren't misleading anyone internally or externally about the timing for approval.  I would also probably request that the head of marketing discuss this with the regulatory team in a different setting so as not to waste valuable time of all of the senior leadership team with the minutia details that will invariably need to be discussed to better evaluate our timeline and any assumptions that are being considered at this point and offer to come back to the senior leadership if there are any changes to the proposed expected timing.

In my experience, if you start to "disagree" or fight your case in front of senior leadership it is highly unlikely that the discussion goes in any positive direction and also can potentially undermine your authority or recognition as the subject matter expert on this sort of question with leadership.  While senior leaders have the ultimate responsibility for their firm's actions, they also have a responsibility to shareholders, employees, patients, etc. to get product out to the market as efficiently as possible so that the company continues to show profitable growth.  And while it seems absurd that 30 days difference in clearance would be seen as something that would adversely impact a company's bottom line - it happens especially when leadership comes out with predictions when the company is a publicly traded enterprise.

Maybe the more important part of the response is how the outside discussion with the head of marketing is planned.  Again, arguing is going to get you and the company nowhere.  The head of marketing has an experience you are unlikely to budge and again, their job is to get the product sold as quickly and as often as humanly possible so the experience is likely to be blinding them to the realities of your specific situation.  I would try to understand just how "similar" that other device was to what you are working on.  I also would acknowledge again that it is possible to get a clearance decision faster than 120 days but that we as a business should not be communicating anything shorter than standard expected leadtimes from the agency to leadership or to the outside world.  All that communication does is places a larger target on your back if the approval comes on day 95 instead of 90 and the target grows literally every day past the stated goal for receipt of the approvals.  Also I would likely selectively assure the head of marketing that the team is diligently working to ensure that the submission is made on time (or earlier if at all reasonably possible) and that the submission will be accurate so as to limit the chances of getting questions or requests for additional data from the agency which should also help to increase the chances of an earlier response from the agency.  

Again, I am always reticent to start arguments or significant defenses of program timing in front of leadership unless it is in response to comments that will seriously derail the discussion itself - something like we should be able to push the FDA for clearance in 45 days or less because their isn't anything "new" for them review would likely make me stop the discussion at that point because the statement itself is likely to bore into the minds of leadership and start them thinking we as a department are overly padding the timeline to assure we don't get questions from leadership about timing.  But outside of something that is that egregious I would likely work to avoid having much of the detailed discussion with the head of marketing in the presence of leadership.

You are making a presentation to the senior management team.  You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a similar device cleared in 90 days."

How should you respond, and what can you do to prevent this situation from occurring in the future?

You are making a presentation to the senior management team.  You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a similar device cleared in 90 days."

How should you respond, and what can you do to prevent this situation from occurring in the future?

These events are best described as a spectrum of probability. I would look up the product code and show a histogram and develop and present a probability table for each  segment of interest. 

You are making a presentation to the senior management team.  You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a similar device cleared in 90 days."

How should you respond, and what can you do to prevent this situation from occurring in the future?

You are making a presentation to the senior management team.  You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a similar device cleared in 90 days."

How should you respond, and what can you do to prevent this situation from occurring in the future?

Input so far has been spot on: be clear about assumptions, use historical data, and don't let the blindside derail the meeting. This assumes you've done your homework to have a solid basis for the timing estimate in the first place, which is critical!

In your response you need to show management that the regulatory team's goals are aligned with the company goals. Convey your commitment to the most timely clearance possible and your intent of setting realistic expectations. The phrasing of the marketing head's statement in this scenario is confrontational and undermines the reputation of your team by attributing the past 90-day clearance to a different regulatory group, so it's important to keep a cool head and not take the bait by getting defensive. Respond with a request for follow up with marketing to learn the details of the experience they are citing and reassert your assumptions and data that led you to the original estimate. And be humble, because maybe you will learn something that the other regulatory group did better. 

The best practice is to collaborate with marketing and other cross functional members of the team to align projections before presenting to senior management. Understand the interdependencies and the impact to others of receiving clearance earlier or later than expected. Also consider presenting more than one date as long as you are clear about the context for each. For example, a best case date so your colleagues are not caught flat footed to launch as soon as possible, and a realistic date to enable best resource utilization for inventory management.

You are making a presentation to the senior management team.  You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a similar device cleared in 90 days."

How should you respond, and what can you do to prevent this situation from occurring in the future?

You are making a presentation to the senior management team.  You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a similar device cleared in 90 days."

How should you respond, and what can you do to prevent this situation from occurring in the future?

Manny other useful thoughts here, but referencing data, i.e. from a recent MDUFA performance report - ideally at the relevant OHT level - may provide value. Solid data can be helpful to combat fuzzy anecdotes.

You are making a presentation to the senior management team.  You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a similar device cleared in 90 days."

How should you respond, and what can you do to prevent this situation from occurring in the future?