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FDA Announces Revision in Presenting Risk & Efficacy Information in DTC Prescription Drug Promotion

FDA announced the availability of Final Guideline for Industry on presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drugs and Biologics, and Animal Drug.


DTC Promotional labeling can be typically defined as any promotional effort by pharmaceutical companies to present prescription drug information to the general public through the various media outlets, such as newspaper/magazine ads, non-medical journals, pharmacy brochure etc. The Office of Prescription Drug Promotion, at FDA oversees the DTC promotional labeling and advertisements, including review of DTC promotional materials submitted by industry as well surveillance and complaint monitoring on DTC promotionals.


While firms are allowed the flexibility of how to present efficacy and risk information of their products, FDA recommends that “ they should consider how to best convey information about a drug’s efficacy and risks so the audience understands the information”.


Recommendations from the guideline is summarized below-


Providing quantitative efficacy or risk information for the control group, when applicable.

Presenting probability information in terms of absolute frequencies, percentages, and

relative frequencies

Formatting quantitative efficacy or risk information

Using visual aids to illustrate quantitative efficacy or risk information:


The goal of the Guidance is to ensure that consumers understand quantitative information about a drug's benefits and/or risks. The final guidance provides quantitative efficacy and risk information in DTC promotion.


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