The FDA wants to study the effects of disclosures in prescription drug ads, particularly ones for cancer drugs. In the past two weeks, the agency proposed two studies aimed at helping it better understand how disclosures, when placed next to claims, affect how patients and HCPs frame the information therein.
One of the two proposed studies will examine the effects of disclosures in oncology promotion. The other will examine disclosures in professional and consumer drug promotion, regardless of the type of drug advertised.
In a notice published in the Federal Register, the FDA wrote that it believes oncology marketing deserves “specific attention” due to the sheer volume of recently approved cancer drugs — 27 in the past 18 months — as well as the rise of new clinical endpoints that serve as the basis for their approval, such as disease-free survival and objective response rate.
The agency defined a disclosure as a “specific statement that modifies or qualifies a claim.” One example of a disclosure can be found in a Bristol-Myers Squibb ad for cancer drug Opdivo, Longer Life. During the ad, text at the bottom of the screen appears while the narrator is explaining the drug’s benefits. The text cautions that “Opdivo does not work for everyone, results may vary.”
Further explaining the rationale for the study, the agency added that “for clinicians who are not specifically trained in clinical trial design, these endpoints may be challenging.” The oncology-specific study will attempt to determine whether disclosures can mitigate misleading presentations of drug data in oncology promotion and whether a disclosure’s wording can influence its effectiveness. The FDA is accepting comments through August 18.
The second study — looking at disclosures in general — will similarly aim to understand if consumers and HCPs are confused or otherwise misled by disclosures. On this second study, the agency is accepting comments on this study through August 14.