Drugs

FDA Pushing EG, DEG Testing

A Reuters analysis of FDA regulatory alerts found that the agency is “cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from contaminated cough syrups.” The news service says FDA has flagged more manufacturers for failing to test raw materials susceptible to ethylene glycol (EG) and diethylene glycol (DEG) contamination in 2023 than in the previous five years combined. An agency spokesperson told Reuters there is no indication that products contaminated with EG and DEG have entered the U.S. supply chain, and further said that the number of Warning Letters issued in a given period “is not a comprehensive marker of our oversight.”

Attorney Peter Lindsay (Paul Hastings) told Reuters the agency is now requiring manufacturers to check individual containers of ingredients rather than just sampling raw materials. “They’re upping the bar a little bit and trying to get industry to understand and recognize some of the risks in these areas,” he said.

Enforcement actions have involved companies based in the U.S. and those that export from South Korea, Switzerland, Canada, and Egypt, the article says.

It reports that cough syrups made in India and Indonesia have been linked to the deaths of more than 300 children globally. The products were found to contain high levels of DEG and EG, leading to acute kidney injury and death. The cases have led to criminal probes, lawsuits, and a surge in regulatory scrutiny worldwide, Reuters says. The news service reported earlier this month that some Indian companies could not prove that they had purchased pharmaceutical-grade ingredients or tested their medicines for the toxins.

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