FDA Policy/General

Gender Statement Added to Restored FDA Pages

Two Web pages on draft guidances that FDA was ordered by a federal judge to restore earlier this week (see story) are back online, but they now include a Trump administration statement that disparages and condemns gender ideology. One draft guidance is intended to increase enrollment of females in clinical trials and interpret sex-specific data, whereas the other is intended to improving trial participation of underrepresented populations. The administration statement reads:

Per a court order, HHS is required to restore this website as of 11:59 PM on February 11, 2025. Any information on this page promoting gender ideology is extremely inaccurate and disconnected from the immutable biological reality that there are two sexes, male and female. The Trump Administration rejects gender ideology and condemns the harms it causes to children, by promoting their chemical and surgical mutilation, and to women, by depriving them of their dignity, safety, well-being, and opportunities. This page does not reflect biological reality and therefore the Administration and this Department reject it.

The Web pages were restored in response to a lawsuit by Doctors for America (DFA), an advocacy group that says it has members in all 50 states and focuses its work on access to affordable care, community health and prevention, and health justice and equity. DFA board member Reshma Ramachandran told the Washington Post that the new language is disconcerting. “These are Web sites that have information that’s been updated based on data, information that’s meant to be based in science, and they put a nonscientific notice just based on ideology,” said Ramachandran, who is an assistant professor at the Yale School of Medicine.

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

Read more

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