Drugs

Steps to Strengthen Drug Supply Chain

FDA and HHS have released a report with policy recommendations to address the vulnerabilities in the nation’s pharmaceutical supply chains. An HHS announcement says the report and its recommendations have been accepted by President Joe Biden.

“Last year the American people experienced a widespread and significant shortage of N95 respirators for healthcare workers and masks to protect essential workers and others, and year after year we see shortages of medicines and medical supplies like saline,” says FDA acting commissioner Janet Woodcock. “Pharmaceutical supply chains are essential for the national and health security and economic prosperity of the United States, yet the Covid-19 pandemic revealed just how vulnerable the supply chain is in this country. Now is the right time to take action to keep the U.S. drug supply chain secure and resilient.”

HHS says it will initially commit about $60 million from the Defense Production Act appropriation in the American Rescue Plan to develop novel platform technologies to increase domestic manufacturing capacity for active pharmaceutical ingredients (API). HHS says greater domestic API production will reduce reliance on global supply chains for medications that are in shortage, particularly during times of increased public health need.

The recommendations center on four pillars:

boosting local production and fostering international cooperation;
promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience;
creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance; and
leveraging data to improve supply chain resilience.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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

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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