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# OPDP Plans New Study on Disclosures in Advertising
- URL: https://www.fdaweb.com/opdp-plans-new-study-on-disclosures-in-advertising/
- Published: 2021-09-10T12:00:00.000Z
- Updated: 2026-09-14T17:14:08.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5150121

CDER’s Office of Prescription Drug Promotion (OPDP) has proposed a new study to examine whether disclosures in direct-to-consumer (DTC) and healthcare provider-targeted advertising could support allowing clinical benefit information based on a secondary endpoint reported in a product’s approved labeling (secondary claim) to be included in such advertising. “In some cases, truthful and non-misleading presentations about secondary endpoints in well-designed clinical studies can provide reliable information about treatment effects that may be distinct from the treatment effects described in the product’s indication statement,” an [agency notice](https://public-inspection.federalregister.gov/2021-19690.pdf?ref=fdaweb.com) says.  

OPDP says the research will examine the impact of adding a disclosure about a secondary claim in DTC and healthcare provider-directed promotion found on prescription drug Web site. “We will also examine the effect of the presence of a comparative claim about the secondary claim,” the notice says. “Our proposed main outcome measures are perceptions of and attitudes toward the product, the secondary claim, and the disclosure.”

A second phase of the proposed research will examine the utility of disclosures in biosimilar product advertising for DTC and healthcare professional audiences. The study will assess the impact of a disclosure designating the product as a biosimilar as well as varying basic factual statements about biosimilars. “This approach allows us to examine the effect of disclosing biosimilar status; examines the additive effect of including one, two, or three additional basic statements of information about biosimilars; and measures the effect of naming the reference product,” OPDP says. “Our proposed main outcome measures are perceptions of and attitudes toward the biosimilar product and the disclosure.”