Drugs

Fewer But Longer Drug Shortages: USP Report

The United States Pharmacopoeia (USP) says the number of drug shortages declined in 2025, but those that did occur lasted longer. The USP 2025 Annual Drug Shortage Report says shortages begin and persist due mainly to four identified risk factors: low price, manufacturing complexity, geographic concentration of manufacturing, and quality concerns.

“Without targeted public and private sector action to improve supply chain resilience, drug shortages may be likely to persist or worsen, threatening patient access to essential medicines and undermining the stability of the U.S. medicine supply,” the report concludes.

USP notes that while the total number of shortages has declined year over year since 2023, the average duration of a drug shortage has grown to over five years. Simultaneously, it says, drug discontinuations have reached their highest level since 2019, with most discontinued products priced well below drugs in shortage, highlighting the economic pressures shaping the supply chain.

The report calls attention to 75 multi-year shortages, 44% of drugs in shortage having at least one key starting material (KSM) solely manufactured in a single country, six shortage drugs having all KSMs solely manufactured in a single country, a 60% increase in drug product discontinuations, and the fact that 26 drugs in shortage rely on China.

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