FDA Policy/General

FDA, CDC Staff Pen Open Letter to Remove RFK Jr.

Calls for HHS secretary Robert F. Kennedy Jr. to leave office are intensifying. Over a thousand current and former staff at FDA, CDC, and NIH have joined a new open letter to Kennedy and Congress, calling for Kennedy to resign or be fired.

"We warn the President, Congress, and the public that secretary Kennedy’s actions are compromising the health of this nation, and we demand secretary Kennedy’s resignation," the letter said. “Should he decline to resign, we call upon the President and U.S. Congress to appoint a new secretary of Health and Human Services, one whose qualifications and experience ensure that health policy is informed by independent and unbiased peer-reviewed science.”

The letter follows increasing turmoil at the department and it cites recent examples, such as:

Facilitating the firing of the Senate-confirmed CDC director, Susan Monarez.
Appointing political ideologues who pose as scientific experts and manipulate data to fit predetermined conclusions.
Refusing to be briefed by well-regarded CDC experts on vaccine-preventable diseases.
Disregarding the President’s Executive Order, “Restoring Gold Standard Science in America”, which has called for transparent science.
Rescinding FDA’s emergency use authorizations for Covid-19 vaccines without providing the data or methods used to reach such a decision.

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