Case 5 “Potency”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion


augmentinThe fifth case is an antibiotic potency. Now, over my career, I’ve been able to work on three particular oral antibiotics, Augmentin, Biaxin, and Cipro, all in slightly different classes of antibiotics, but all with a similar kind of message or claim, and that is the broad spectrum coverage of a lot of bacteria and less resistance to those potentially affected bugs.

Now the regulatory lesson here is that the idea of spectrum coverage always had to have a footnote that in-vitro activity did not necessarily imply in-vivo efficacy. In English, that meant that just because in a petri dish the antibiotic was shown to cover a certain bacteria, it wasn’t necessarily the case that it would act that way in a real life patient.

The idea of resistance, though, was certainly promotable. Especially with Augmentin. We were able to show clinically that there were fewer recurring infections, which meant the patient didn’t have to come back because first line antibiotic failed. This has particularly important implications for kids going to school so they wouldn’t have to take school off again, for working parents not having to get their children out of daycare because of recurring infections, or even the adults themselves not having to continue to miss work.

These clinical claims were based on not only spectrum coverage, but also clinical trial results on less recurring infections.

 

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