Drugs

236 Potential Drug Shortages Prevented in 2023: FDA

FDA says that while there were 55 new drug shortages in CY 2023, actions by the agency, manufacturers, and other groups successfully prevented 236 potential shortages. The information is in the agency’s 11th annual report to Congress on drug shortages. It says that of the 55 new shortages, 33 involved drugs handled by CDER, and 22 involved biological products handled by CBER.

The agency says that while the number of annual new drug shortages has decreased significantly from the record high of 251 in 2011, “shortages continue to pose a real challenge to public health, particularly when the shortage involves a critical drug, such as those used to treat cancer, to provide parenteral nutrition, and to address other serious medical conditions.”

The report says the requirements related to the early notification of permanent discontinuances and interruptions in manufacturing and FDA’s actions are helping to reduce the threat and impact of drug shortages. It says FDA has in its FY 2025 budget request proposals that would include authorities intended to promote the agency’s response efforts, such as requirements for manufacturers to notify FDA of an increase in demand that the manufacturer likely will be unable to meet without meaningful shortfall or delay, and to provide manufacturing volume and supplier information.

FDA says it is working to identify opportunities to reduce the risks of drug shortages, including gaining fuller insight into the supply chain and increasing supply chain resilience.

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

Read more

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