KKB has expertise in all aspects of prescription and OTC drug labeling. We advise on the proper wording, formatting, submission and/or approval of labels, labeling (such as detail pieces), advertising and other promotional materials (including social media and internet promotion). We advise on the interpretation of OTC monographs and Drug Facts labeling for OTC drugs. We also advise on the use of educational activities and communications with healthcare professionals, and the preparation of policies governing legal compliance for pharmaceutical promotional activities. We also advise on state law in this area, such as laws governing reporting of gifts to healthcare professionals.

KKB advises on Medicare and Medicaid reimbursement issues and corporate compliance programs. We also advise on Prescription Drug Marketing Act compliance with drug sampling rules