After 13 years, the FDA has finalized the 2010 proposed rule addressing drug ads on TV and radio. The rule concerns the major statement relating to side effects and contraindications, that they be presented in a “clear, conspicuous and neutral manner.” The final rule’s summary is a 27-page-long report that is comprehensive, sometimes repetitive, and narrowly focused on the presentation of the major statement. It also includes a summary of the comments they received during the two comment periods along with their responses to those comments.

Realizing that not everyone has the time to breeze through a long government document, especially when you’re about to walk into a meeting with your PRC team, we’ve highlighted the key portions of the document in this downloadable PDF: Presentation of the Major Statement in Ads in TV and Radio_highlighted.pdf Use this as a reference to get to the key aspects of this rule, in particular:

  • The use of audio to present the major statement (volume, speed)
  • Ensuring the major statement is presented in a “clear, conspicuous, and neutral manner”
  • Restriction from including anything that could be distracting while presenting the major statement
  • Use of on-screen text
  • Dual modality (use of audio and text at the same time)
  • Use of quantitative terminology
  • Use of positive visual imagery during the reading of the major statement

When you need to refer to this final rule, open the highlighted PDF (best in Adobe Acrobat), where we have added highlighted comments of the main points to speed up your understanding of the rule.

As you can tell, we have a lot of experience in counseling pharmaceutical and biotech companies on the rules and regulations for social and digital marketing. Reach out to us if we can be of help to you.

About the Author:

Matthew Snodgrass is a lead in Digital & Social Strategy at Syneos Health in New York. He has more than twenty years of experience in digital marketing with a concentration in health and pharmaceuticals. Matt helps bring digital marketing campaigns to life while shepherding them through MLR review teams with numerous pharmaceutical companies. He has also helped to develop policy and training for employees and brand communicators in the area of social media.