FDA Policy/General

Brukinsa TV Ad ‘False or Misleading’: OPDP

The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad for BeOne Medicines’ Brukinsa (zanubrutinib) capsules and tablets is false and misleading and thus misbrands the drug. A 5/12 Notice of Violation says the totality of claims and presentations made through visuals in the ad “misleadingly suggests that Brukinsa will allow patients to ‘see their futures clearly’ by leaving treatment considerations or concerns aside and impacting their health-related quality of life, such as improving emotional functioning and physical functioning, when this has not been demonstrated.” Brukinsa is indicated for treating chronic lymphocytic leukemia.

OPDP also says the totality of the ad’s claims and presentations misleadingly suggests that the drug has a superior safety profile, including a lower risk of cardiovascular events, particularly atrial fibrillation, relative to ibrutinib (Janssen’s Imbruvica).

The letter also cites issues with the video and audio of the major statement and the timing of presenting the major statement when the ad’s emotional story reaches its peak.

BeOne was told to respond with a list of all promotional materials for Brukinsa that contain representations like those cited and a plan for either discontinuing such communications or halting distribution of the drug.

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