FDA Policy/General

Revised Shutdown Plan Sees 58% of FDA Staff Still at Work

As the threat of a government shutdown grows stronger due to a fiscal year 2018 budget impasse, a revised HHS contingency staffing plan reveals a higher number of FDA staff would stay on the job than earlier estimated (see earlier story). The contingency plan details that 58% (10,050 staff) would be retained under a government shutdown, while 7,244 would be furloughed.

According to a new Alliance for a Stronger FDA analysis, “food safety will be particularly hard-hit, as will routine inspections. Certainly, medical product companies with near-term expectations—review meetings, initiating clinical trials, etc.—are faced with the possibility of slippage in their development timelines.

“We know,” the Alliance continues, “that product review programs that are partly paid by user fees will be staffed, but won’t be fully-staffed because taxpayer funding will not be available. Based on past shutdowns, products on which user fees have already been paid (e.g. NDA’s) are more likely to be staffed than earlier stage activities. However, we do not know where the precise lines are being drawn and cannot provide assurance than any given activity will be continued (or fully continued or not continued) during a shutdown.”

Should a shutdown occur, the Alliance is betting that it won’t last more than a week. The effects at FDA are hard to calculate. “A short government shutdown will have consequences, but few are likely to be visible,” the Alliance notes. “The amount of time the agency will need to catch-up is probably longer than people realize, especially in offices that have vacancies and are already under heavy workload pressures. If the government is shut for a week, it may take several weeks (in some cases, longer) for the backlog to be worked down.”

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