Comparative Claims: CFL Guidance Gives Opening; OPDP Research May Close It

25 Nov 2019

US FDA’s 'consistent with labeling' guidance prompts more sponsors to consider comparative promotional claims, but any minimization of product safety issues still runs the risk of enforcement, legal experts say; Office of Prescription Drug Promotion’s research agenda on consumer understanding of Rx ad claims could result in an attempt to limit comparative claims.

compare apple to orange white background - Image — Sponsors are rethinking their approach to comparative claims thanks to a US FDA guidance. • Source: Shutterstock

The US Food and Drug Administration’s “consistent with labeling” final guidance has opened the door wider for biopharma manufacturers interested in making comparative promotional claims, but companies nevertheless are moving cautiously across the threshold.

That was the consensus of legal experts during a panel on the FDA’s evolving approach to comparative claims at the...