The FDA is finally finalizing its rule on the need for direct-to-consumer ads to present side effects and contraindications “in a clear, conspicuous and neutral manner” more than 10 years after closing the third and final comment period.
In 2010, the FDA proposed changing its regulations on DTC ads that run on TV and radio to address the Food and Drug Administration Amendments Act requirement for the “major statement relating to side effects and contraindications [to] be presented in a clear, conspicuous and neutral manner.” The FDA ran one comment period in 2010, and two after the release of a study of viewers’ understanding in 2012.
Then, public signs of progress stopped. In its final rule, the FDA blames the 11-year hiatus on “competing demands for limited agency resources, such as repeated redirection of personnel into emergency operations for natural disasters, the opioid epidemic, and infectious disease outbreaks including Ebola, Zika, and the COVID-19 pandemic.”
Now, the FDA wants to finalize the rule without seeking additional input from the industry. In the agency’s view, the “rulemaking is both procedurally and substantively sound.” The three comment periods offered “meaningful opportunities” to comment, no parties have requested additional chances to give feedback and there are no material changes to the concepts, facts, research or existing standards, the FDA said.
Based on that conclusion, the FDA is finalizing the rule based on the more than 70 comments it received in 2010 and 2012. Most of the feedback expressed support for the proposal, according to the FDA, but there were requests for clarifications and calls for the agency to conduct more research before finalizing the rule.
The final rule, which is set to take effect May 20, establishes a set of standards for determining if an ad complies with the need to be clear, conspicuous and neutral. The standards cover the need for the information to be presented in consumer-friendly language and terminology, and in audio and text at the same time in video ads. Audio should use the same volume, articulation and pacing as the rest of the ad.