There is absolutely no roadblock in the US (other than something they could be sued for) to a doctor dispensing any drug on or off label if a patient is willing to pay for it when insurance doesn't (insurance doesn't cover hearing aids so it's probable they won't cover this either).
In theory could a doctor be sued for negligence if they prescribed a medication off-label to treat a condition that it hadn't been approved for by FDA?
I ask this because Frequency Therapeutics approach to FX-322 being used off-label and Hough's approach to its pill being used off-label are completely contrary to each other. This is despite both Frequency Therapeutics' and Hough's medicines being theoretically able to treat other conditions to those that they will be FDA trialled and also approved for. Thus both would be candidates for off-label prescription.
Frequency Therapeutics stated that while they won't allow FX-322 to be used off-label (including early access) at this time, there also do not appear to be any barriers present which may prevent off-label use being granted in the future.
On the other hand:
Hough won't allow their pill to be used off-label in any form and has said that a FDA compliant tinnitus study must take place prior to its use. This is because doctors could potentially lose their licence and potentially be sued due to negative outcomes stemming from using its pill to treat conditions it isn't FDA trialled for. Hough has also stated that this is why they need to fund a tinnitus study/trial.
I see Hough's reasons why they can't allow off-label use as being quite far-fetched from a legal perspective.
This is because:
- if the medicine is safe (FDA requires this to be demonstrated before it can even be prescribed off-label)
and
- there is evidence to show that the medicine is effective to treat the condition it is being prescribed for (even if it hasn't obtained final FDA approval)
I cannot fathom how a doctor could get sued for negligently prescribing Hough's pill off-label.
Even a report into testing the pill's effect on tinnitus as a secondary measure (like what Frequency Therapeutics is purportedly doing with tinnitus in phase 2) which shows favourable results would surely be enough to absolve a doctor from being deemed negligent in prescribing Hough's pill off-label. This is because they can reasonably and fairly rely on this information to support their decision to prescribe it.
Thus I would like to know do companies and doctors actually require sound evidence such as completed FDA trials to demonstrate that it is acceptable to prescribe a medicine off-label to someone for a specific condition to avoid getting sued?
or
Can a medicine be prescribed off-label to treat a condition providing a doctor knows it is safe and is actually unlikely to have any adverse outcomes?
I just find it incredibly interesting that there are two approaches being applied to off-label use here with one entity claiming that the off-label use requirements are a lot more stringent then they actually appear to be.