FDA Policy/General

White House Sought Resignation of Top Makary Aide

The White House recently requested the resignation of a senior aide to FDA commissioner Marty Makary, highlighting growing friction between FDA leadership and Trump Administration senior staff. The aide, Sanjula Jain-Nagpal, had been slated for a promotion to deputy chief of staff, which Makary had advocated, but the White House had not yet approved, according to Politico.

According to administration officials, Makary resisted the resignation request, maintaining that Jain-Nagpal remains an FDA employee, the news report says. HHS spokesperson Andrew Nixon confirmed that “she is an employee at the FDA, and that has not changed.”

Jain-Nagpal, listed as a health informatics specialist in the HHS directory, had drawn attention when she announced in a call with FDA stakeholders that she was serving as Makary’s deputy chief of staff — a title not formally sanctioned by the White House. After discussions, the administration decided she would retain her original title.

The dispute underscores ongoing tension between Makary and both HHS and White House leadership, following a series of controversial personnel decisions. In recent months, the agency has faced high-profile departures and rehiring battles, including the temporary removal and reinstatement of CBER director Vinay Prasad, and the resignation of top drug regulator George Tidmarsh amid allegations of misconduct.

Makary has also resisted calls from HHS secretary Robert F. Kennedy Jr. to expand vaccine safety studies, citing the need to first develop a new surveillance system (see earlier story).

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