FDA Policy/General

Stop Inaccurate Health Info: HHS Staff to RFK, Jr.

More than 750 current and former HHS staffers have signed an 8/20 letter calling on HHS secretary Robert F. Kennedy, Jr., to “stop spreading inaccurate health information” in the wake of an 8/8 shooting at the Atlanta, GA, headquarters of the Centers for Disease Control. CNN reports that the letter, which was also sent to members of Congress, noted that the shooting was not random, with the Georgia Bureau of Investigation reporting that the alleged shooter “had expressed discontent with the Covid-19 vaccine and wanted to make his distrust known.”

The letter says the attack came during growing mistrust in public institutions, driven by politicized rhetoric that has turned public health professionals from trusted experts into targets of villainization and violence. Those who signed the letter said they were speaking “in our own personal capacities.” Some signed anonymously “out of fear of retaliation and personal safety.”

The letter’s signers said Kennedy “is complicit in dismantling America’s public health infrastructure and endangering the nation’s health by repeatedly spreading inaccurate health information.”

The HHSers asked Kennedy to “cease and publicly disavow the ongoing dissemination of false and misleading claims about vaccines, infectious disease transmission, and America’s public health institutions,” affirm the scientific integrity of CDC, and guarantee the safety of the HHS workforce.

It is likely that FDAers who signed the letter are fearful of a copycat attack over their agency’s role in authorizing Covid-19 vaccines and therapeutics.

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