GoingToMeet

Whether it’s the age-old battle of getting a label approved — or emerging conflicts over postmarket revisions — labeling remains one of the most intense negotiations the drug industry has with the FDA. Labeling has always been a factor, but today, approvals and revisions have taken on a whole new dimension with the FDA’s new emphasis on careful deliberation and approval of new drugs (not to mention postmarket safety). Consider: * The key drug labeling case of Wyeth v. Levine, in which the Supreme Court held that federal regulatory approval of a medication does not shield the manufacturer from liability under state law; * Ongoing challenges with off-label promotion in the wake of hard-hitting prosecutions by U.S. attorneys resulting in multimillion-dollar legal settlements; and * New SPL format rules and their effect on labeling and medical communications. This coming July, there will be an exceptional opportunity to buttonhole key FDA players plus the top lawyers, industry experts and others able to clarify new labeling requirements.