Drugs

FDA Inspection Backlog Can Hurt Canada: Analysis

With Health Canada conducting only 15% of the country’s inspections of drug manufacturers, Canada has relied on international inspectors, primarily from FDA, which has accounted for 70% of Canada’s inspection reliance. In an online post, Benefits and Pensions Monitor says the backlog in FDA international inspections can hurt the Canadian drug industry.

The post quotes reports from the U.S. Governmental Accountability Office (GAO) that have flagged drug supply chain oversight as “high risk” since 2009. The agency still has not returned to pre-Covid-19 pandemic inspection levels, the post says. In 2024, a GAO report said it “has had long-standing concerns about FDA’s ability to oversee the increasingly global drug supply chain.”

The report quotes Duke University professor David Ridley that, “Many of these establishments are not being inspected by Canadian or U.S. officials.” He warned the situation could result in “low quality products, products that don’t work as well, aren’t as stable, and in a very worst case scenario, are toxic.”

Ridley said it has made sense for countries to partner with FDA for inspections. “FDA is so big and the United States is so big,” he said. “We have the scale. It does make sense to partner with us. But that’s conditional on being able to count on us to make those foreign trips.”

Health Canada director general Kim Godard told the newsletter that her agency is adapting to industry changes. “We’re following the context, we’re following the trends, we’re following the technologies, we’re following what’s happening in the pharmaceutical industry,” Godard said. She said Health Canada’s goal is to ensure that it can meet the demands of tomorrow.

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