By John Kamp, Executive Director, Coalition for Healthcare Communication
While the headlines cite implausible rates of non-compliance with FDA marketing regulations, a close reading of the recent PLOS One article, “Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing,” demonstrates:
1. the stated preference (bias) of the authors for their own brand of marketing regulation and
2. the underlying challenge industry, doctors and patients face under the current FDA regulation of drug ads.
Simply put, no one knows for sure what”s compliant until the FDA says so, most often in a FDA warning letter. This serves no one including doctors, patients, FDA and industry. Regardless of the authors regulatory preferences, they are absolutely correct in this conclusion: “The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic
safety and efficacy information.” Everyone loses under the current standards because the rules prevent good communication and subject the industry to unwarrented criticism from the press, politicians and medical professionals and uneven, unpredictable enforcement from FDA. Better regulations would enable better informed patients and doctors, thus better patient care.
The Coalition filed a Citizen Petition in March of 2006 asking the FDA to create clear, objective standards for professional and consumer advertising. It”s time for widespread industry dialogue on how to improve these rules to better serve the public health.
The PLOS article can be found on the PLOS website: http://www.plosone.org/article/info:doi/10.1371/journal.pone.0023336
The Coalition Citizen Petition: