Drugs

HHS Defines FDA Roles in Drug Shortages

An HHS white paper on “Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States” discusses some of the roles that FDA plays and wants to play in responding to drug shortages. The paper says the agency’s response focuses on the intake of information from various sources to determine if a shortage exists or is expected. “FDA can then plan and execute strategies to help mitigate or prevent the impact of shortages,” it says.

FDA, the report says, is developing a framework that would evaluate Quality Management Maturity (QMM) at drug manufacturing establishments. “The QMM assessment would help gauge adoption of management practices that support a more reliable drug supply chain by reducing the occurrence of quality-related failures and improving the ability of drug manufacturers to maintain performance during supply chain disruptions, whether expected or unexpected,” the HHS report says. “The framework may be used to develop metrics about the adoption of manufacturing practices that enhance supply chain resilience and which purchasers, providers, and consumers could then use to inform their purchasing decisions.”

The report also addresses the need for more transparency and notes that FDA has created a Web page that compiles various FDA inspection-related data. Also, it says, the agency issued final guidance on 2/5 for reporting the annual amount of listed drugs produced for commercial distribution.

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