FDA Policy/General

Attorney Warns: FDA Watching Professional Promotion

A recent notice of violation that was issued by the CDER Office of Prescription Drug Promotion (OPDP) to Mayne Pharma about a Nextstellis professional promotion is a reminder that OPDP puts as much energy into reviewing promotions targeting healthcare professionals as it does with direct-to-consumer promotions. That’s a caution from attorney Nathan Downing (Gardner) in an online post.

Downing says the notice of violation said the company’s speaker deck misrepresented the safety profile of Nextstellis, particularly concerning its estrogen component. The presentation also minimized the drug’s serious risks, OPDP said.

“Companies should take this untitled letter as a reminder of the importance of ensuring that all promotional materials accurately reflect the FDA-approved labeling and do not overstate the benefits or understate the risks of a product,” Downing writes. He advises companies to:

review and revise promotional content;
implement robust review processes; and
educate marketing teams on FDA promotional guidelines and regulations.

“By proactively addressing these areas,” Downing concludes, “medical products companies can mitigate the risk of regulatory scrutiny and maintain compliance with FDA standards.”

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