Did You Make the List? FDA Identifies Preference Sensitive Therapeutic Areas

Identifying a relevant preference-sensitive, product related question is one of the greatest challenges facing the medical device industry when trying to determine if patient preference data will be a useful addition to a regulatory strategy.  A preference study really has no value unless there is a preference-sensitive and clinically relevant product question to be addressed.  For example, if a device provides immediate quality of life benefit, but has uncertain long-term toxicity, the preference sensitive question is whether patients are willing to tolerate the uncertainty of long-term toxicity to obtain the benefit of substantially improved quality of life given the other benefits and risks of available treatments.  Similarly, if a device can be implanted with minimally invasive techniques, but has uncertain durability, the preference-sensitive question is whether patients are willing to tolerate the uncertainty of durability in order to avoid more invasive surgery given known benefits and risks.  The list of potential preference-sensitive questions could be infinite across therapeutic areas.  Fortunately, for industry, FDA has generated a list of preference-sensitive areas that they are most interested in.  The medical device industry needs to take full advantage of this.

What is most important for industry is that the areas identified by CDRH were suggested by the review teams in each of the divisions.  That means that if your device falls into one of these preference-sensitive areas, your review teams may be more interested in considering patient preference data.  This is hugely important for device sponsors who have faced uncertainty about whether their product reviewers will even look at patient preference data. This uncertainty undermines the potential value of obtaining preference data and reduces the likelihood that sponsors will invest in conducting these types of studies.  Knowing that your review team is interested in addressing preference-sensitive questions is an important step in the right direction for sponsors and FDA. 

So, what do you do if your product area is on the list?  Start engaging with your reviewers on how patient preference data could support your product right away.  There are staff at the agency with specific expertise on how to conduct patient preference studies and how to ensure they are clinically relevant and meaningful to your regulatory strategy.  Keep in mind that these studies take 6 – 18 months to do depending on their complexity, the patient population, recruitment strategy, and prevalence of disease.  Don’t wait until the last minute to decide to go get these data.

Need more information about how to include patient preference data in your regulatory or clinical strategy?  Reach out to me and let’s figure out the best way to make that happen for your patients and products.