In December last year I wrote the following paragraph as a post scriptum to the batch of Patient Voice articles that I wrote:

There is a difference amongst companies in how seriously they take the Patient Voice agenda. But I wonder what commitment there would be if there were no longer any regulatory pressures in place. Here is a thought experiment: let’s suppose that Trump 2.0 makes cuts to FDA that indirectly causes an unravelling of a raft of regulations and best practice guidance in relation to the Patient Voice, particularly in the area of diversity. Let’s suppose this undoing has an impact on the ability of FDA to assess submissions, where capacity may disappear altogether. The result is that patient voice initiatives are no longer expected or properly regulated. No more real-world evidence (RWE) research required, no more cognitive debriefing, or comprehension testing, or risk evaluation and mitigation strategies (REMS) or anything to do with patient safety or health literacy. In this new reality, how many clinical research organizations (CROs) and Pharma companies do you think would still insist on Patient Voice research in drug development? How many sponsors would do it voluntarily? How many Patient Voice slogans decorating their conference booths? You would count them on one hand.

Prescient? Nah, everybody must have seen this coming. The unravelling of binding and non-binding guidance to do with the Patient Voice could well happen. It could happen unintentionally, or it could be a deliberate cut, where the executioners fail to understand the basic premises of something like Patient Voice research and assume it has some other agenda. After all, in their zeal to do away with any guidance relating to gender-based pronouns, they also killed FDA guidance around the use of pronouns when communicating to patients. This was not a document motivated by identity politics. All it did was advise medical writers to communicate directly to patients, using the pronoun ‘you’. This was instead of using constructions that avoid addressing the patient directly, such as the passive voice or the third person ‘patients must take care to avoid drinking when taking this medicine’. Nothing ‘woke’ about it. It’s very sensible advice aimed to empower the patient. Yet, the scattergun (or scatter-algorithm?) approach has dragged this guidance up into the same net as what they perceive as the more controversial pronoun guidance. Maybe they are reviewing all that they pulled – as they say they are - and will restore it when they realise it is not on their kill list. I hope so.

Returning to the scenario of the unravelling of FDA guidance - and cuts and chaos and bottlenecks of submissions - it could be that nothing is submitted, or nothing is approved, and nothing is done any more in terms of any kind of Patient Engagement, and clinical studies are hobbled before they get going. In a free-for-all scenario of no rules or reduced rules, innovators may well seek a new home outside of the USA. Markets ultimately decide.

We, the bottom-feeders,

we, the purveyors of solutions that are low in prestige,

we, the providers of services that partners won't or cannot do,

we, the mopper-uppers, beholden to nobody.

We would do well to keep a keen eye open for developments in new services in new geographies,

and follow the money.

Written by Mark Gibson

Leeds, United Kingdom February 2025