FDA Policy/General

Sharpless Supporters More Vocal

Representatives of 57 healthcare advocacy organizations and four former FDA commissioners have written to President Donald Trump and HHS secretary Alex Azar urging that they nominate FDA acting commissioner Ned Sharpless to become the permanent commissioner. Under federal regulations, Sharpless can only serve as acting commissioner until early November, the Washington Post reports. HHS declined to comment to the newspaper on the letters or on Sharpless’ prospects.

The letter from the 57 organizations praises Sharpless as “the best person to be nominated and confirmed as the next commissioner…. During his brief time at FDA he has continued to navigate and direct the agency in a manner that best benefits patients and is effectively executing the critical work of the agency. His presence has been a calming force, which has gained him the respect of the agency staff and those that support its mission.”

The Post reports that earlier this summer there were indications that Sharpless was being considered along with Harvard dermatology professor Alexa Boer Kimball and an unnamed doctor at M.D. Anderson Cancer Center. Later, concern was expressed that Azar may be supporting HHS assistant secretary for health Brett Giroir, at least to be acting commissioner. Giroir has implemented controversial policies including antiabortion initiatives and restrictions on federal funding for fetal tissue research, the newspaper reports.

The four former commissioners who endorsed Sharpless were Mark McClellan, Robert Califf, Margaret Hamburg, and Andrew von Eschenbach. The former commissioner who Sharpless replaced, Scott Gottlieb, said he “fully supports” the nomination and confirmation but didn’t sign the letter to avoid any post-employment restrictions limiting his contact with federal health officials, the Post 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