FDA Policy/General

Trump Poised to Nominate Hahn to FDA: Report

The Washington Post says it has learned that President Donald Trump is about to name MD Anderson chief medical officer Stephen Hahn to be FDA commissioner, succeeding acting commissioner Ned Sharpless. The Post says Hahn, 59, is a radiation oncologist and researcher who has been described as an “energetic consensus-builder with a disarming, folksy manner.”

Sharpless’ term as acting commissioner ends 11/1, but he could stay in place during Hahn’s confirmation, which could take months. Sharpless had expressed strong interest in being named permanent commissioner and had won support from dozens of cancer and other medical groups and several former commissioners. However, the newspaper says, Trump turned to Hahn after meeting with him in early September.

Hahn moved from the National Cancer Institute to the University of Pennsylvania in 1996 and was chair of radiation oncology from 2005 to 2014. He then moved to MD Anderson in Houston as division head of radiation oncology and in 2017 was named the center’s chief operating officer at a time of mounting financial losses and staff cuts. He oversaw the center’s day-to-day operations and reportedly earned good reviews for his role in its financial turnaround and rebuilding of staff morale.

The Post says Hahn is a registered Republican who has contributed to some Republican campaigns, including the 2012 presidential run of Mitt Romney, and a few Democratic campaigns. Sharpless is not registered with either party and contributed to some Democratic candidates, including former president Barack Obama.

Texas state records list Hahn’s salary for the current fiscal year as $933,600, with total compensation of $1.3 million. The FDA commissioner earns about $160,000. Hahn is married with four adult children, the profile says.

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