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01-09-2011 | Article

Most US drug adverts do not adhere to FDA guidelines

Abstract

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MedWire News: An analysis of approximately 200 US pharmaceutical advertisements indicates that the majority of such adverts fail to adhere to guidelines set by the US Food and Drug Administration (FDA).

Indeed, more than 50% of doctor-directed print advertisements in biomedical journals did not quantify serious side effects of the advertised drug, explain Deborah Korenstein (Mount Sinai School of Medicine, New York, USA) and co-investigators.

"Current FDA guidelines are subjective and challenging to enforce and do not emphasize transparency and the inclusion of basic information relevant to prescribing.

"Increased enforcement of the current regulations would help improve advertisements, but the subjectivity of the guidelines presents a substantial barrier," say Korenstein and team.

They therefore advise that future updates of FDA regulations should stress the importance of the inclusion of basic safety information in advertisements.

The analysis, published in the open access journal PLoS ONE, involved 192 pharmaceutical advertisements for 82 different drugs published in nine biomedical journals in November 2008.

The investigators assessed each advert for adherence to FDA advertising recommendations and the presence of important information for safe prescribing, such as risk information, quantification of product benefits, and verifiable references.

In all, only 18.1% of the adverts adhered to all 20 FDA Prescription Drug Advertising Guidelines.

More specifically, 49.4% of adverts failed to adhere to at least one guideline, and 32.5% of adverts were identified as "possibly" non-adherent because information on a specific aspect of the drug's actions or properties was incomplete.

Safe prescribing information was often partially omitted, with 57.8% of advertisements failing to quantify serious risks, 28.9% failing to quantify product benefits, and 48.2% lacking verifiable references.

"Our study, the first in nearly 20 years to provide a systematic assessment of the adherence of US advertisements to FDA guidance, shows that the current system is not in the best interest of the health of the public," said Korenstein.

The investigators conclude that their findings have "important policy implications." They suggest that new FDA guidelines that state objective drug advertising requirements will help to improve prescribing practise and public health via improved advertisement quality and transparency.

By Lauretta Ihonor