FDA Policy/General

HHS Says No Orders from Trump on Communication Blackout

Despite reports that the Trump Administration has issued an communication blackout at federal agencies, including FDA, an HHS official told FDA Webview 1/24 that no such order exists. PEN America, an organization that says it stands at the intersection of literature and human rights to protect open expression in the U.S., says numerous federal employees have expressed concern that the alleged communications blackouts will impede work, disrupt communication across branches of the government, and leave the public in the dark.

“Blanket orders from the Trump Administration preventing the staffs and experts of federal agencies from communicating with the public send a chilling message that every governmental communication, no matter how routine or technical, will now be subject to a political litmus test,” said PEN executive director Suzanne Nossel. “Federal officials are being cut off from the American public, impairing their work and denying the American citizenry access to necessary information and understanding about the work of our federal government. These blunderbuss and draconian measures infringe upon free expression and the flow of information and ideas, imposing constraints that befit an autocracy, not American democracy. They should be rescinded immediately.”

However, an HHS official contacted by FDA Webview had this to say:“Contrary to erroneous media reports, HHS and its agencies continue to communicate fully about its work through all of its regular communication channels with the public, the media and other relevant audiences. There is no directive to do otherwise.”

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