Labeling, Advertising & Promotion

HPM attorneys assist pharmaceutical, biologics, and medical device clients with the preparation and dissemination of promotional and advertising materials about their products.  In a highly-regulated environment where what you say about your products is heavily scrutinized by federal and state government authorities as well as other third parties and the public, HPM attorneys can help with creating, reviewing, and publicizing the commercial messaging and materials used to sell your products.  Whether company-sponsored communications happen over the TV, radio, the Internet, in magazines, in branded, written materials in hard copy or electronic form, or in the form of verbal communications by company field sales representatives, HPM can advise on the legal framework and, more importantly, can work collaboratively with you to craft compliant promotional messages, materials, and sales tactics.

HPM attorneys seamlessly interact with company commercial, regulatory, medical, and internal legal teams to develop product claims and promotional materials in compliance with the applicable regulatory standards.  Our attorneys have the background and experience to work with you to:

• establish company policies and procedures related to product labeling and promotional and advertising materials for prescription and OTC products,
• develop pre-approval communications for use with various stakeholder groups,
• create robust launch materials,
• conduct initial and ongoing legal review of product labeling and advertising and promotional materials,
• interact with FDA groups such as OPDP, APLB, and CDRH during routine correspondence or in response to administrative or enforcement actions.

HPM attorneys have, collectively and individually, many years of experience serving as outside counsel and ad hoc or interim brand attorneys assigned to company therapeutic areas or products, and providing legal review and representation on company Medical, Legal, and Regulatory review teams.  In each of these capacities, we have worked closely with Marketing and other areas of the business (e.g., managed markets, health economics) to develop robust promotional messaging and materials essential to selling drugs and devices.