FDA Policy/General

Could Sharpless Get ‘Trumped’ by HHS Asst. Secretary?

FDA acting commissioner Ned Sharpless may be on the out as President Trump has not nominated him to be the permanent agency head, and under the Federal Vacancies Reform Act of 1998 he can only serve in a Senate-confirmed position for a maximum of 210 days, which would give him about another 60 days or until 11/1. According to a report on BioCentury.com, HHS secretary Alex Azar may be considering pushing for HHS assistant secretary for health Brett Giroir as FDA commissioner. If Giroir is nominated, Sharpless could remain as acting director until the Senate confirmation process is completed. After that, Sharpless could be headed back to his previous post as the head of the National Cancer Institute, the report speculates.

“Giroir was brought into the Trump administration by former Texas Governor and current Secretary of Energy Rick Perry,” BioCentury reports. “Giroir is viewed in Washington as an Azar loyalist, a designation that puts him in conflict with White House Domestic Policy Council director Joe Grogan.” If Giroir lands at FDA, the report says there are concerns FDA could lose some of its independence and that it could become “enmeshed in political controversies involving importation, reproductive health and other issues... Controversy about Giroir’s positions on reproductive rights led Democrats to hold up his confirmation as assistant HHS secretary for nine months.”

Giroir is a physician and an admiral in the U.S. Public Health Service Commissioned Corps. BioCentury notes that he was appointed CEO of Texas A&M University Health Science Center in 2013, and in 2015 a new university president terminated his employment after giving him 30 minutes notice. When he was confirmed as HHS assistant secretary, Giroir resigned as president and CEO of ViraCyte (Houston, TX).

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