Friday was a busy day at the FDA as three guidance documents were released. The first was a draft guidance on Brief Summary and Adequate Directions for Use. The second was the final guidance on Medical Devices Data Systems. The third was updates to the Mobile Medication Applications guidance. There’ll be more on the second and third guidance documents later this week.
On February 6, 2015, the Food and Drug Administration (FDA) released a new draft guidance entitled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling. The FDA strongly recommends against the use of the traditional approach to disclose risk information and fulfill the brief summary requirement in consumer-directed advertisements. Instead, the agency outlines an alternative approach that it is calling a “consumer brief summary,” which encourages a less-is-more-approach that reduces requirements for disclosing risk information. It’s worth noting that this guidance is only for consumer advertising. It does not apply to advertisements directed at health care professionals.
- New recommendations for consumer brief summary only apply to consumer-directed materials
- The FDA strongly recommends against use of the traditional approach to fulfill the brief summary requirement in consumer-directed advertisements with the use of the full FDA-approved package insert (PI)
- The FDA also strongly recommends against providing the PI
- New recommendations for using a consumer brief summary do not change requirements for the main body of promotional materials
- The consumer brief summary should be presented visually in a manner similar to the promotional content
- Simplify language to be more consumer-friendly
In light of this guidance, Digitas Health LifeBrands recommends companies take the following actions:
- Review all consumer promotional materials in market and in development and assess where to use a consumer brief summary
- Choose the format of the consumer brief summary
- Decide on a time frame for updating the current brief summary
- There is no time frame for adherence to these new recommendations
- Comments on the proposed guidance will be accepted for 90 days, after which the FDA will review and decide how to proceed
- Determine if multiple consumer brief summaries are necessary for co-promotions or products with multiple indications
- MLR, brand managers, and agencies should work together to determine the appropriate steps to implement the new guidance
Read more on this guidance here.
– Noah Beytin, Director, Regulatory Review