Drugs

Device ‘Spot Shortages’ Reported to FDA

FDA says it has received reports of “spot shortages” of some medical devices due to the global coronavirus outbreak. An FDA spokeswoman tells FDA Webview 2/27 that the agency is “currently not aware of specific widespread shortages of medical devices, but we are aware of reports from CDC and other partners of increased ordering of a range of human medical products through distributors as some healthcare facilities in the U.S. are preparing for potential future need if the outbreak were to become more severe. The FDA asks that hospitals report any device shortage concerns to the FDA.”

Earlier this week, FDA commissioner Stephen Hahn said that no pharmaceutical firms have reported drug shortages due to the coronavirus, including the approximately 20 drug products that are solely sourced from China. The agency said that it “has been reaching out to over 180 manufacturers and reminding them of their requirement to notify FDA of any anticipated supply disruptions. In addition, we have asked them to evaluate their entire supply chain, including active pharmaceutical ingredients and other components manufactured in China.”

Meanwhile, U.S. senator Josh Hawley (R-MO) 2/27 introduced legislation, The Medical Supply Chain Security Act, to help secure the U.S. medical product supply chain. “The coronavirus outbreak in China has highlighted severe and longstanding weaknesses in our medical supply chain,” Hawley said in a release. “Our health officials need to know the extent of our reliance on Chinese production so they can take all necessary action to protect Americans. This legislation will give us the information we need to better secure our supply chain and ensure that Americans have uninterrupted access to life-saving drugs and medical devices.”

Hawley says his bill would:

Require that manufacturers report imminent or forecasted shortages of life-saving or life-sustaining medical devices to FDA just as they currently do for pharmaceutical drugs. The new information on devices would be added to the agency’s annual report to Congress on drug shortages.
Allow FDA to expedite the review of essential medical devices that require pre-market approval in the event of an expected shortage reported by a manufacturer.
Give new authority to the FDA to request information from manufacturers of essential drugs or devices regarding all aspects of their manufacturing capacity, including sourcing of component parts, sourcing of active pharmaceutical ingredients, use of any scarce raw materials, and any other details FDA deems relevant to assess the security of the U.S. medical product supply chain.

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