Drugs

Drug Shortage Announcements Can Lead to ‘Protective Purchasing’: USP

Nearly half of drug shortage announcements led to protective purchasing intended to safeguard patient access, according to a report in the United States Pharmacopeia online Quality Matters newsletter. While protective purchasing is intended to preserve patient access, the report says, it can have the unintended consequence of deepening supply disruptions by concentrating demand, increasing waste, and exacerbating inequities. As a result, it says, some patients, particularly in smaller or rural healthcare settings, may be unable to obtain essential medicines even as total product volume sold continues to rise.

The article says that improved visibility and coordination are essential to reducing drug shortage impacts, helping to align purchasing behavior with real supply conditions and protecting patient access.

The analysis found that:

injectable dosage forms show a stronger near-term response than other dosage forms;
antibacterials, pain medications, oncologics, dermatologics, and antihypertensives experience the largest initial surges;
acute use drugs experience stronger responses than chronic use therapies;
generic products demonstrate substantially larger first-month increases than brand-name drugs;
products listed on the World Health Organization or FDA essential medicines lists experience larger post-shortage surges than non-essential medicines; and
drugs that are chronically in short supply show similar purchasing patterns to the broader set of shortage drugs with protective purchasing.

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