Daily Archives: April 11, 2016

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

The 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 […]