The Language of Risk – FDA’s Evolution of Thought

How does the average patient assess the risk of a medical product when deciding whether or not to seek it out?

This month, FDA released a new draft guidance document entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drug Products” which revised a 2004 draft guidance – “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements“.

Regulations require that when companies produce promotional materials that the risk information be included.  This was referred to as the Brief Summary. To fulfill this requirement, manufacturers often included the entire risk related sections of the package insert – which could be lengthy and which are written at a very high level of medical understanding which the agency has come to conclude was not of great utility due to the fact that patients/consumers were really not that likely to read, consume and understand the contents. In addition, the information included was voluminous, containing a good deal of detail. Therefore while it technically complied with regulation, it did not meet the objective – which was to inform the patient/consumer.

With the revised guidance, FDA provided new thinking on the “Consumer Brief Summary” – creating a pathway for risk information to be presented in a more consumer-friendly method with more relevance and less detailed information by focusing on the most important information and leaving out the exhaustive profile of the risk.

FDA believes that the brief summary should focus on the most important risk information rather than an exhaustive list of risks and that the information should be presented in a way most likely to be understood by consumers. Thus, FDA strongly recommends against the use of the traditional approach to fulfill the brief summary requirement in consumer-directed advertisements, an approach in which risk-rlated sections ofthe PI are presented verbatim, often in small font….Furthermore, the risk information int he PI sometimes includes lengthy lists of all possible adverse events. In general, FDA believes that exhaustive lists that include even minor risks detract from, and make it difficult for, consumers to comprehend and retain information about the more important risks.

The draft guidance is specific to prescription drugs, but appears to reveal an underlying shift of thinking by the agency to which we were perhaps given a prelude when the agency released its draft guidance “Internet and Social Media Platforms with Character Space Limitations – Presenting Risk Information for Prescription Drugs and Medical Devices” in which FDA enunciated the policy that the most important and essential risk elements could be profiled in linked material, but that the platform in which there was a character-space limitation (for all intents and purposes – a tweet or an online advert) could make reference to the material deemed most pertinent, i.e., contraindications, boxed warnings, etc.

In the new guidance, FDA makes clear that it will not object if a firm does not include “each specific side effect and contraindication” from the package insert (PI) and then lays out the pathway by which a firm can supply risk information without the full PI which in part, includes:

  • Avoiding medical jargon and devise reading level to apply to large consumer population;
  • Using headlines and subheadings to denote important information;
  • Information addressing the following should be included:
    • Boxed Warning
    • All contraindications
    • Certain information regarding Warnings and Precautions
      • the most clinically significant information from the Warnings and Precautions sections of the PI
      • information that would affect a decision to prescribe or take a drug
      • monitoring or laboratory tests that may be needed
      • special precautions not set forth in other parts of the PI
      • measures that can be taken to mitigate or prevent harm
    • Most frequently occurring adverse reactions
    • If a product has more than one indication, then it should be included for each indication, even if the promotional material is limited to a particular indication and listed in the same order as the PI
    • Clinically significant drug interactions

Because the information that will be presented in this new version will not be comprehensive, FDA wants this Consumer Brief Summary to include reference to that fact and to link the consumer back to the fuller information. The guidance also provides suggestions for formats for the new information. (Note, this is not a comprehensive overview of the requirements contained in the draft guidance and all are encouraged to read it in its entirety.)

One may wonder what impact, if any, this guidance may have in other areas of promotional speech. It is reasonable to assume that given the guidelines contained in the draft guidance on character space limitations and in this guidance that FDA is moving down a path whereby abbreviated versions of risk information are, under select circumstances, acceptable and even at times preferable. Time will tell.

With respect to this particular draft guidance, the comments section is currently open. It remains to be seen how this guidance will be put into place once comments are considered. It does not appear that comments have so far been received. Also how FDA’s OPDP enforcement – which has been on a low volume scale – chooses to further clarify FDA’s outlook on what information gets included in what type of format.

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