We continue to examine the Pacira case documents and give this settlement in-depth thought across all areas of our FDA regulatory practice. As we hinted in our December 17th post, we believe this case could have significant reach. Most obviously, there are implications for the advertising and promotion of drug products, and undoubtedly, FDA will try to limit the applicability of the settlement. At minimum, the case influences the interpretation of labeling for drugs similarly situated to Exparel – i.e., they have: a) a broad indication based on pivotal trials that focus on a more narrow patient population or disease sub-type or stage; b) favorable or ambiguous labeling and regulatory history on point; and c) a medical and scientific argument (and ideally FDA guidance) that supports extrapolation from clinical study populations to broader populations. Less obviously but just as important, there also may be implications for clinical development strategies and labeling negotiations. If this case signals a change in the Agency’s interpretation of a product’s indication, it could also weigh heavily in life cycle plans, where the scope of a product’s approval can affect opportunities for future market exclusivity and could even impact the scope of the patents that may be listed in FDA’s Orange Book for a given drug product.
