FDA Policy/General

‘Anemic’ FDA Ad Enforcement Seen

An analysis of CDER Office of Prescription Drug Promotion (OPDP) enforcement actions in 2020 by Eye on FDA found the same pace as in recent years, what the online publication calls “anemic levels of enforcement.” The post says the six regulatory letters were exclusively aimed at smaller, less experienced companies. “Whether that is by design, or by virtue of the fact that they are more prone to regulatory error, is not clear,” it says.

Of the six letters sent, five were Warning Letters and one was a Notice of Violation (Untitled Letter). Five of the letters involved products with Boxed Warnings, while four of them involved digital communications. Two of the letters cited traditional direct-to-consumer ads — one on television and one on radio.

The six letters contained 13 violations — six for omitted or limited risk information, one for an unsubstantiated claim, two for broadening an indication, one for unapproved use, and three in the “other” category, which included failing to use the established name in the promotion. Risk omission or minimization was an element in all of the letters, the post says.

Eye on FDA reports that OPDP leadership appears to be prioritizing reviewing launch materials for new drugs and focusing on enforcement for specific categories where there is a high risk, such as pain medications, and situations where there is a greater risk as represented by the presence of a Boxed Warning.

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