FDA Policy/General

Returning FDA Staff to Face Space, Parking Issues

FDA reportedly has informed its staff that they will likely face parking and office space problems when they return to in-office work on 3/17. Reuters says it has seen transcripts of division meetings in which the likelihood of disruptions was discussed. The report also says that plans for upcoming staff layoffs were being developed by HHS with input from FDA acting commissioner Sara Brenner. CDER employees were told that Brenner is an advocate for FDA who understands user fees and the unique skills of many agency employees, the news agency reports.

Staff returning to the FDA main campus in Silver Spring, MD, were advised to carpool and use public transportation as much as possible and to be prepared for delays in clearing enhanced security. They were told to only carry essentials with them. Some staff may have to work at conference room tables with other employees, they were told.

Reuters says the National Treasury Employees Union, which represents HHS employees, encouraged staff to document working conditions, including the time they spend finding parking and going through security.

The information on how a reduction in force is being approached follows Trump administration instructions that HHS submit reorganization plans by 3/13. It appeared that staff covered by user fee programs would not be subject to dismissal because those programs are authorized and renewed by Congress. But staff paid from agency budgeted funds could face layoffs.

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