Drugs

Continue Modernizing Foreign Inspections: Study

Academic researchers say FDA should continue modernizing its foreign inspection framework, ensuring that high-import-volume mutual recognition agreement countries such as Ireland receive scrutiny proportional to their market share, and developing additional metrics to assess whether the unannounced inspection mandate translates into measurable improvements in oversight rigor. Writing in the open-source Journal of Pharmaceutical Innovation, the researchers say the combined inspection-per-billion-U.S. dollars and inspection-outcome-rate frameworks established in the study “offer forward-looking tools to evaluate these policy outcomes as the agency adapts to the globalization of pharmaceutical manufacturing.”

The researchers say they found that increasing import volumes corresponded with declining inspection frequencies from 2014 to 2019. For every additional billion dollars of drug imports to the U.S., they say, there were 23 fewer inspections conducted during 2014-2019. Additionally, while import volumes increased in leading import nations, inspections declined over the same period in most cases.

“The reality of declining inspection volumes based on sheer import of pharmaceutical products into the United States is clear,” the authors say. “FDA’s foreign inspection activity did not keep a uniform pace with the globalization of pharmaceutical manufacturing. Over half of manufacturers supplying the U.S. market are now overseas, many of which are located in India and China. This assessment of nations that import pharmaceutical products to the United States reveals significant disparities in enforcement practices between countries under mutual recognition agreements and those without such agreements. FDA oversight of drug manufacturing in allied MRA regions appears less intensive relative to the volume of imports, whereas countries like China and India face far more frequent scrutiny.”

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