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# Comments Sought on ‘Limited Risks’ DTC Major Statement
- URL: https://www.fdaweb.com/comments-sought-on-limited-risks-dtc-major-statement/
- Published: 2017-08-18T12:00:00.000Z
- Updated: 2026-09-14T22:42:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139420

FDA has [announced](http://fda.pr-optout.com/Tracking.aspx?Data=HHL%3d834%2f%3a6-%3eLCE38%2b87%3e7-GLCE17.6&RE=MC&RI=4528954&Preview=False&DistributionActionID=67934&Action=Follow+Link&ref=fdaweb.com) the availability of a public docket for submitting comments about the development of recommendations regarding the content of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs. “The FDA helps to ensure that when firms choose to advertise prescription drugs directly to consumers and patients, such advertisements provide useful information to that audience, including information about a drug’s risks presented in the ‘major statement,’” the announcement says. “There is concern that the major statement, as currently implemented in DTC broadcast ads, is not fulfilling this purpose. Therefore, FDA is exploring the usefulness of limiting the risks in the ‘major statement’ to those that are severe (life-threatening), serious, or actionable, coupled with a disclosure to alert consumers that there are other product risks not included in the advertisement.”

As [previously announced](https://www.fdaweb.com/new-dtc-research-examines-new-risk-presentation-model/), FDA is researching the effectiveness of this “limited risks plus disclosure” approach to help inform the agency’s decision making in this area. The agency has outlined questions for stakeholders to address, including those related to: 

- Available data on current approaches of risk information communication and consumer comprehension of risk information
- Effects of only including certain risks (severe, serious, actionable) and ways to characterize included risks
- Options for including language on other types of risks
- Criteria for identifying risk information that is most material to the patient/consumer versus to the healthcare provider
- Criteria for determining which of the material risk information to include in the major statement
- Effects of including (or not including) disclosure language with a limited risk presentation to alert consumers that there are other risks not included in the advertisement
- Availability of data regarding consumers’ comprehension of different levels (i.e. severity) of risk information
- Considerations related to identifying and disclosing potential food and drug interactions.