At the heart of a case involving a prescription drug is the question of risks – what risks exist, what risks were known, and what risks were warned about. All of us have seen prescription drug advertisements that include a vast amount of information about warnings and risks in fine print, often using language that is confusing and difficult to understand. Not surprisingly, much of the content goes unnoticed. This poses the question: When a risk is included in an advertisement, but in such a fashion that it is almost impossible for a consumer to understand, can one truly argue that it is effectively warned about?
The FDA is delving into this issue, and has issued new draft guidance suggesting that drug-makers use “consumer-friendly” advertisements and promotional materials. The language should be simplified so that it can be understood “by a broad target audience with various levels of literacy skills.” This means that “medical jargon” and other technical language should be eliminated. Further, the guidance addresses style and design, noting that the presentation should be designed for ease of use by consumers. Most importantly, the FDA encourages companies to limit the content of advertisements, including only “clinically significant information on the most serious and the most common risks associated with the product,” but not necessarily an exhaustive list of each and every side effect of a drug. The reason is because “[e]xhaustive lists that include even minor risks detract from, and make difficult for, consumers to comprehend and retain information about the more important risks.” In other words, providing less information that focuses on the most important risks of a drug will ultimately be more meaningful to a consumer.
Following this guidance, drug companies will have to undergo a level of analysis to determine what to include and what to leave out, which has the potential to become an important consideration when pursuing legal claims in the future. The FDA does provide guidance on how to evaluate this information, and also how to relay that an advertisement is not comprehensive, which places a certain amount of responsibility on the consumer. There is a 90-day time period for comments to be made on this draft guidance. Then, the FDA will determine how to proceed and if the guidance should be adopted. This is simply guidance, a recommendation based on the FDA’s current position, and does not establish a legal standard. Even so, it stands to impact the way that drug companies advertise to consumers, and legal claims related to this issue.
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