FDA Policy/General

Senate Sets 11/20 FDA Confirmation Hearing

The Senate Health, Education, Labor & Pensions Committee has scheduled an 11/20 confirmation hearing for FDA commissioner nominee Stephen Hahn. President Trump nominated the MD Anderson chief medical officer 11/1, the same day former acting commissioner Ned Sharpless was ordered back to his previous position as National Cancer Institute director. While Hahn navigates the Senate confirmation process, HHS assistant secretary for health Brett Giroir will manage FDA’s day-to-day activities. Giroir was sworn in at HHS 2/2018.

Trump chose Hahn after interviewing him in September. He 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.

Senate health committee chairman Lamar Alexander (R-TN) said in a 11/6 statement that he had an “excellent meeting” with Hahn and that he is well-qualified to lead FDA. “As an oncologist, Dr. Hahn knows firsthand the importance of bringing new, lifesaving drugs and devices quickly through the regulatory process as well as the need for innovation for patients with debilitating and chronic pain,” the chairman said. “This is a crucial perspective at a time when FDA is implementing the 21st Century Cures Act, regulating tobacco and vaping products, addressing the opioid crisis, and protecting our nation’s food supply.”

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