FDA Policy/General

FDA Remaking Inspection Priorities in Wake of Trump Cuts

FDA is looking to reprioritize its planned inspections for the rest of the year due to challenges it faces after 170 administrative and management staff were cut 4/1 under HHS’s mass firings. Many routine surveillance inspections will likely fall to the wayside as the agency prioritizes “for cause” inspections, such as those the examine a safety risk product recall, senior FDA officials told CBS News.

One area of concern is that the layoffs eliminated FDA’s travel operations staff who planned and booked investigators’ foreign and domestic travel plans. This ranged from booking flights to coordinating with the State Department to reserve translators needed for inspections abroad. “As of yesterday, all front-line investigators will now be spending significant time processing their own travel and related administrative requirements, rather than spending that time in firms ensuring the American consumer is protected," one FDA official told CBS.

FDA’s unannounced inspection pilot program that involved foreign inspections has been paused due to the cuts, an official said, because of the loss of staff that had been tasked with assisting with the program.

Inspections will still take place, but the cuts will likely worsen delays caused by other challenges such as the Trump administration’s actions to cut spending in recent months. For example, FDA officials told CBS that its investigators have been hampered by a new government-wide $1 spending limit on credit cards, adding that any spending above that limit requires a cumbersome approval process.

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