Drugs

FDA Acting Drugs Head to Leave Agency Soon: Report

CDER acting director Tracey Beth Hoeg is expected to leave the agency just days after the resignation of former FDA commissioner Marty Makary, according to three people familiar with internal planning, Reuters reported Friday.

Hoeg, an epidemiologist and sports physician who drew criticism during the Covid-19 pandemic for questioning aspects of U.S. vaccination policy, helped lead an effort earlier this year to overhaul the nation’s childhood immunization schedule under the direction of HHS secretary Robert F. Kennedy Jr. The proposed changes, announced in January, would have reduced the number of recommended childhood vaccine shots from 17 to 11. The overhaul was later paused amid litigation challenging broader vaccine policy changes pursued by HHS under Kennedy.

Hoeg has been serving in a temporary capacity after replacing then-Center director Rick Pazdur (see story). Her selection in December had raised concern with public health experts because of her past criticism of Covid-19 policies and vaccines.

Her expected departure likely fits in with recent White House orders to tone down and curtail public commentary on vaccines as part of a deliberate political strategy by the Trump administration (see story). An internal memo reported by Bloomberg outlines a “low-risk messaging” approach that sidelines vaccine rhetoric in favor of less polarizing issues ahead of the 2026 midterm elections. Internal polling cited by administration officials found that vaccine policy — long a central focus of Kennedy’s “Make America Healthy Again” agenda — has become politically unpopular with key voting blocs.

“HHS and FDA do not comment on personnel matters,” HHS spokeswoman Emily Hilliard said in a statement.

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