FDA Policy/General

FDA Rehiring Some Travel Support Staff

FDA is working to rehire about one-third of the 60 travel support staff who were fired as part of an agency-wide reduction in force. The Associated Press reports the agency also plans to recall food scientists who were fired, but they have not yet received formal written notification of their return to work. The news service’s reporting was based on information from staffers who spoke anonymously.

The story says Freedom of Information Act (FOIA) staff may also be slated to return since the agency recently has missed multiple court-ordered deadlines to produce documents, which AP says could lead to significant fines. About 100 FOIA staff members were caught up in the terminations.

“The apparent reversals are the latest examples of the haphazard approach to agency cuts that have shrunk FDA’s workforce by an estimated 20%, or about 3,500 jobs, in addition to an unspecified number of retirements, voluntary buyouts, and resignations,” the story says.

The report says agency inspectors long relied on travel bookers to coordinate trips to India and other countries that often involve visa permissions, security measures, ground transportation, tech support, translation services, and other logistics. For a brief time in April, inspectors were told they would be booking their travel themselves and were referred to an agency hotline to help with the arrangements. Then FDA executives developed a plan to hire an outside contractor to do the work. And now it is trying to rehire about 20 of those who were fired, according to the AP.

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