The FDA is moving closer to kicking off two proposed studies around drug advertising risk information and disclosures—one to study DTC print ads and the other professional promotions.
The agency recently posted second public notices for both, addressing questions and comments raised after the initial filing and opening the next 30-day comment sessions. After that 30-day period, the FDA will initiate the studies, an agency spokeswoman said by email.
The DTC study looks to evaluate the amount and location of risk information in DTC print ads. Researchers will test different ads with and without brief summary statements, which are commonly placed after the main part of print ads, as well as with long or short Important Safety Information (ISI), which is usually contained in the main part of the print ad. The study will use eye-tracking techniques and mocked-up ads in two two different conditions: overactive bladder and rheumatoid arthritis.
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The new filing also addressed questions and comments left by five commenters during the initial 60-day period. Those posts came from Eli Lilly, Novartis, AbbVie, the industry trade group PhRMA and an individual self-described as a market researcher.
The market researcher questioned several aspects of the study, including the omission of repeated exposures and its size, along with a suggestion to keep more information for consumers.
“It seems like the research is front loaded to give the answer that the FDA is looking for—give less information to consumers so that they think less about the sides effects of the product and buy more product. Please don't think consumers are dumb and can't make educated decisions. Consumers should be given all the information to make an informed choice by themselves not determined by what the FDA or other governmental organization feels is what they can handle,” the commenter wrote.
The DTC risk study is open for additional comments through Sept. 13.
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The second study concerns professional promotions and disclosures of efficacy claims. Its purpose is, as written in the filing, “to determine how useful disclosures regarding prescription drug information are when presented prominently and adjacent to claims. Specifically, are HCPs and consumers able to use disclosures to effectively frame information in efficacy claims in prescription drug promotion?”
The new posting for the professional study also addressed questions and comments raised, including those from PhRMA, Eli Lilly, Novartis and Leo Pharma. It is open for additional comments through Sept. 10.