Research Article: Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing

Date Published: August 17, 2011

Publisher: Public Library of Science

Author(s): Deborah Korenstein, Salomeh Keyhani, Ali Mendelson, Joseph S. Ross, Ulrich Thiem.

Abstract: Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.

Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1–14). Six “teaser” advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.

Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.

Partial Text: Advertising is a crucial component of pharmaceutical industry marketing around the world and advertising in biomedical journals is estimated by industry to be its most profitable marketing strategy [1]. Furthermore, physician exposure to advertisements has been associated with increased prescribing of advertised drugs [2]. Beyond marketing, proponents of physician-directed advertisements, mostly from within the pharmaceutical industry, emphasize the important role advertisements play in educating physicians and other prescribers about new drugs [3]. However, critics have raised concerns about the quality of the information presented in these physician-directed advertisements, including a focus on relative, not absolute, benefit [3]–[5] and poor referencing [6]–[8]. Although systematic assessments of advertisement content to promote evidence-based prescribing have been limited [9], [10], one previous study found that physician-directed advertisements did not promote guideline-adherent patient care [11], and critics have argued that advertising may harm patients and adversely impact public health [12].

In this study we found that nearly half of physician-directed advertisements fail to adhere to at least one FDA guideline regulating content. Physician-directed advertisements contained bias with regard to a wide variety of issues across content areas addressed by FDA guidance; there was no single problem that was consistently identified for non-adherence. In addition, we found that advertisements do a poor job of conveying basic information necessary for safe prescribing, with the majority failing to quantify serious risks, more than one quarter failing to quantify benefits and nearly half providing no verifiable references. Our study is the first in nearly 20 years to provide a systematic assessment of the adherence of U.S. advertisements to FDA guidance and provides context to inform the FDA’s new “bad ad” program.