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Regulatory Focus™ > News Articles > 8 > FDA to Study Disclosures in Prescription Drug Ads

FDA to Study Disclosures in Prescription Drug Ads

Posted 08 August 2018 | By Ana Mulero 

FDA to Study Disclosures in Prescription Drug Ads

The US Food and Drug Administration (FDA) plans to conduct a study to determine the usefulness of disclosures in prescription drug advertisements.
“The proposed research will examine the effectiveness of clear and conspicuous disclosures in prescription drug promotion directed to” healthcare professionals and patients “when presented prominently and adjacent to claims,” the agency said in a notice from Wednesday.
The agency laid out several revisions made to the design of the study, which was first announced last June, in response to comments from stakeholders.
The study design is centered on three research areas that will be separately analyzed: Scope of treatment, ease of use and statistical significance. FDA said it “selected these types of information because they are commonly seen in promotional material.”
Study participants will be presented with three promotional pieces with weak, strong or no disclosures after undergoing pretests for which FDA will use eye-tracking technology to determine whether the disclosure statement was actually viewed and for how long.
FDA has embarked on several other initiatives to address current research gaps and inform how prescription drug advertising and promotional labeling are regulated.
In March, FDA said it intends to survey doctors on their understanding of clinical trial data in drug ads and conduct a separate study on their perception of risk information.
Last year, the agency also announced plans to assess consumers and care professionals’ ability to identify deceptive or misleading information in drug ads.


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