In summary, I presented seven relevant cases and some key learnings for promotional guidance. In a new class, the mechanism of action needs to be pulled through to show that it actually made a difference in the clinical trial results. In the pharmacokinetics, we saw that a difference on label of PK performance could have promotionally relevant and competitively viable differences in dosing.
In drug delivery and release, we saw that the profile of the therapeutic window could be promotional, allowed, if it were also shown to be patient-relevant in either efficacy or side effects. When we looked at dermatological efficacy, we saw a wide range of differences between products that could only talk about dry skin and the visible signs of aging, like many cosmetic and OTC products, ranging all the way to very well-studied prescription products that do have clinical trial results showing reduced wrinkles.
When it comes to antibiotics spectrum and potency, we saw that the in-vitro spectrum or potency must be demonstrated in the in-vivo or in-patient use actual results. In the sixth case of surrogate end points, we saw two examples of products that were shown to reduce markers of a disease, but did not have the clinical studies powered sufficiently to show the improvement in disease outcomes. Finally, in number seven, we saw an ingredient performance that performed well in a laboratory demonstration project, but did not have the clinical trial design in order to show or to promote a real patient difference; in this case, a reduction in blood clotting.
One of the things you see throughout these cases is that there are a number of mechanism, PK, spectrum and potency, and end points, even lab performance that must be demonstrated in clinical trials and be in the labeling to be promotionally allowed. This is the overall lesson learned that I think we can take from these and many other cases.
I really appreciate the chance to share this information with you. Disclaimer: I have made every reasonable effort to ensure that the information in this is correct at the time of this presentation. I’ve designed this as a general educational resource, not for rendering any personal professional advice, but simply to share some of my experiences with you. There are trademarks and service marks used in this presentation that are the property of their respective owners.