Drugs

Surge in Product Recalls Predicted

International business management consultancy Sedgwick says that while product recalls, including drugs and medical devices, have dropped during the pandemic, there is likely to be a surge in recalls as businesses return to more normal operating conditions. In a statement, Sedgwick says that in the first quarter of 2021, medical device recalls fell 9.8% compared to the fourth quarter of 2020, resulting in a seven-quarter low. Software issues were the leading cause for recalls for the 19^th time in the last 20 quarters.

Pharmaceutical recalls dropped 25% to just 63 events in the first quarter. Sedgwick says that was despite FDA efforts to resume inspections and regulatory enforcement in late 2020 and early 2021.

The firm says the medical device industry is on the brink of a regulatory crackdown. “The scope of safety investigations will continue to broaden, accelerating innovation will reshape the regulatory framework, and lawyers will aggressively test the waters on the level of immunity the Public Readiness and Emergency Preparedness Act offers to manufacturers.

On the drug side, Sedgwick says, contamination risks have always been a long-standing risk for drug companies. “As the industry evolves,” it says, “expect heightened regulatory scrutiny, litigation, and reputational fallout as a result. Meanwhile, independent labs and safety advocates are eager to pursue products that may be placing consumers at risk, and their influence is growing.”

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