How to Avoid Improper Claims in Pharmaceutical Communication

In Colombia, the line between legitimate scientific information and improper drug advertising is documented with regulatory precision, and crossing it — even unintentionally — carries consequences ranging from suspension of the advertising to significant financial penalties.

Decreto 677 de 1995 established general guidelines for promoting prescription drugs at scientific or technical events and in publications aimed at healthcare professionals, explicitly prohibiting advertising of these products directed at consumers ^[1]. The regulation is clear on one governing principle: all scientific, promotional, or advertising information about medicines must align with the conditions of the product's sanitary registration ^[2]. Not what the brand would like to communicate, but what the registration actually supports.

The framework was recently updated with Decreto 334 de 2022 and Resolución 1896 de 2023, which regulate in more detail non-advertising information, promotion, advertising, and marketing of medicines and phytotherapeutic products ^[3]. Under this regulation, INVIMA does not require prior approval of advertising, but it does exercise active post-hoc control — meaning compliance responsibility falls entirely on whoever produces and distributes the material, not on prior authority validation ^[3].

For over-the-counter medicines, Resolución 4320 de 2004 requires that advertising be objective, truthful, and not exaggerate the product's properties, and that it not induce indiscriminate, unnecessary, or inappropriate use ^[4].

Improper claims are rarely intentional: they usually originate from optimistic extrapolation of a study result — taking a statistically significant finding in a specific population and communicating it as if it applied generally — or from omitting nuances that the sanitary registration does account for. A regulatory claims matrix, built before the promotional material is produced rather than as a post-hoc review, is the most effective tool for systematically preventing this risk.