Drugs

FDA Ramps Up Global Drug Quality Oversight

FDA has sharply expanded its drug quality enforcement efforts since the end of the Covid-19 Public Health Emergency, with foreign oversight reaching all-time highs, according to the agency’s latest State of Pharmaceutical Quality report. FDA investigators conducted 972 drug quality assurance inspections in fiscal year 2024 — nearly double the 522 completed in 2022 and up from 766 in 2023, according to the report. The total includes both routine surveillance checks and targeted “for-cause” inspections at domestic and foreign facilities.

Foreign oversight accounted for more than 62% of all inspections last year — the highest share ever, the report says. The number of FDA-conducted inspections abroad jumped from 146 in 2022 to 555 in 2024, supplemented by inspections performed by mutual recognition agreement (MRA) partners, which also hit a record high of 198. India and China were top priorities, with 34% and 28% of registered sites in each country inspected, compared with 24% of U.S. sites, it says.

Inspection results showed high compliance rates overall: 93% of facilities worldwide received either “No Action Indicated” or “Voluntary Action Indicated” classifications, the report says. Compliance rates ranged from 87% in India to 98% in Europe.

Warning Letters surged to a five-year high of 105, driven largely by the uptick in inspections. More were issued to foreign sites, including 13 in China — most tied to document review requests — and nine in South Korea, where failures to test for dangerous contaminants like diethylene glycol, ethylene glycol, or methanol were common violations.

Additionally, drug recalls climbed 15% to 260 events in 2024, though the number of products per recall was the lowest in five years, according to the report. The share of recalls linked to manufacturing practice deficiencies dropped from about 50% in previous years to 24%, while contamination-related recalls made up the bulk of the rest. Most recalls were tied to facilities in the U.S. (48%) and India (41%).

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