Drugs

OPDP Plans New Study on Disclosures in Advertising

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 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.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome