FDA Policy/General

Did Trump Ban ‘Woman’ and ‘Disabled’ at FDA?

The White House says a list of more than 20 “prohibited words” that has been circulating at FDA may have misinterpreted the Trump administration’s gender ideology Executive Order. Reuters reports it was told by two sources familiar with the matter who requested anonymity out of fear of professional repercussions that the list included the words “woman,” “disabled,” and “elderly.”

The agency scientists told the news service that neither they nor their managers knew who issued the directive or why many of the specific words were included.

“I don’t understand why we can’t use a word like ‘woman,’” one FDA source told Reuters. “The words on the list would make it almost impossible to do our jobs.”

The article says the list Reuters was shown included words such as underrepresented, underserved, understudied, sex, identity, diverse, woman, women, promote, definition, continuum, ideology, self-assessed, special populations, elderly, and disabled. The list was not accompanied by an explanation, Reuters says.

The FDA sources told the news service they had been told by colleagues that the list originated in CDRH. A White House spokesman told Reuters that most of the words on the list don’t need to be removed from communications and the error may have resulted from a misinterpretation of the Executive Order on gender ideology. However, the spokesman said the agency should prohibit the use of gender, inclusion, identity, diversity, inter, intersex, equity, equitable, transgender, and trans to comply with the order.

An FDA spokesperson said the agency does not have an official list of banned words and would not comment to Reuters on the White House position that some words can’t be used.

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