FDA Policy/General

Trump’s FDA External Affairs Chief Named

FDA acting commissioner Stephen Ostroff 3/20 announced the appointment of longtime Republican operative Jack Kalavritinos to be the agency’s new associate commissioner for external affairs, responsible for FDA communications to the media, Congress, and the general public, effective immediately. In an email to FDA senior staff, Ostroff said Kalavritinos, who is a lawyer, most recently served as a special assistant in the HHS Office of the Secretary, from the Trump transition team.

Prior to that, Ostroff’s message said, Kalavritonis had “worked in the public affairs arena for over 20 years and has developed a strong health care background both at HHS and in the private sector. He served in the administration of president George W. Bush as director of intergovernmental affairs at HHS. He was secretary Mike Leavitt’s liaison to the nation’s governors, state, local and tribal leaders. He led a team of national and regional policy experts, liaisons and public affairs staff during the roll-out of Medicare Part D. He was instrumental in organizing and implementing pandemic flu emergency preparedness summits with secretary Leavitt and governors of all states, territories and tribal leaders. He helped to support secretary Leavitt’s efforts post-Hurricane Katrina to establish rapid response efforts with Gulf state governors and other state, local and tribal leaders.

“Jack worked on medical device issues in the private sector and worked closely with that industry’s association, AdvaMed, on domestic and international policy issues.”

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