FDA Policy/General

2019 Ropes & Gray FDA Enforcement Review

Ropes & Gray says that FDA and the Justice Department “took significant regulatory and judicial action in 2019 that brought attention to alleged compliance gaps across the medical and health product industries, focusing on entities potentially making higher-risk products and on foreign and domestic facilities that may have received less attention in the past.” In its “2019 FDA Enforcement Review,” the firm says the Justice Department continued to use the False Claims Act to take enforcement action in connection with the conduct by FDA-regulated companies that some might claim falls within the agency’s regulatory orbit.

But, it says, the number of False Claims Act-only settlements focused on core FDA regulatory issues continue to diminish as the Justice Department’s civil and criminal fraud units focus more of their attention on anti-kickback theories and more traditional healthcare fraud.

The document recaps notable enforcement actions involving FDA-regulated entities in 2019 and comments on trends likely to continue in 2020 involving opioids; product quality and manufacturing; unapproved products or intended uses; reporting, data integrity, and other requirements; and False Claims Act update.

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