Attorneys Offer 'New Model' For FDA Regulation Of Off-Label Promotion

As FDA faces a legal challenge to its off-label promotion policies, and lawmakers push the agency to release long-awaited guidance on the issue, a group of four industry attorneys is offering a middle ground they feel strikes a balance between drug makers First Amendment rights and maintaining the integrity of the agency's approval process. In their “New Model” the attorneys create three categories of manufacturer communications -- Scientific Exchange and other Exempt Communications, Non-Core Communications, and Core Communications -- which...