We advise life sciences companies on FDA-regulated product communications, including promotional review, scientific exchange, competitor challenges, and responses to FDA advertising and promotion enforcement. We help clients evaluate promotional and scientific communications in view of the approved labeling, claim support, fair balance, risk presentation, audience, channel, and overall impression.
We do more than identify regulatory risk. Promotional and scientific communications must be defensible under FDA standards, but they also need to support real business objectives, including launch readiness, clinician education, patient awareness, market access, investor confidence, and competitive positioning. Our goal is practical, business-minded advice that helps clients communicate effectively while managing regulatory risk.
Alexander Varond advises on FDA advertising and promotion issues across the product lifecycle, from pre-approval communications and scientific exchange through launch planning, promotional review, and post-market promotion. He brings a practical, commercially minded perspective to this work, drawing on his experience in drug development, FDA engagement, enforcement, corporate diligence, and disputes.
Alex has advised life sciences sponsors on promotional review and claim substantiation, scientific exchange and medical affairs communications, pre-approval and disease-awareness communications, and product launches. He has also counseled on responses to FDA advertising and promotion enforcement. On the competitive side, he has assisted clients with successful trade complaint letters and with responses to Lanham Act and other unfair-competition claims brought by competitors.
Alex co-authored the chapter on "Promotion and Marketing of Prescription Drugs, Biologics, and Devices" in Practicing Law Institute's FDA Deskbook.