Drugs

Half of FDA Employees Likely to Stay Home Under Shutdown

Almost half of FDA employees would be ordered to stay home under a current budget impasse if Congress and president Donald Trump can’t come to terms by midnight 1/19 on funding for fiscal year 2018. It is possible that a continuing resolution could be negotiated that would delay any shutdown until later next month.

An HHS contingency plan provided to FDA Webview by the Alliance for a Stronger FDA shows justification for about 55% of the FDA workforce to stay on the job under a government shutdown, with most of those funded through industry-paid user fees. However, a large percentage of the user fees (one fourth or about $600 million) support tobacco-related activities, and the agency’s other operations would be greatly impacted.

The Alliance recently analyzed the impact on FDA if a shutdown occurred based on earlier HHS directives, and it found the agency’s situation to be “complex because of its multiple funding sources and several personnel systems. As a result, FDA’s ability to maximize the number of retained employees is particularly sensitive to any changes in the OMB [Office of Management and Budget] directives and HHS’s interpretation and implementation.”

As a baseline, previous government shutdown guidance from HHS directed FDA to continue activities related to its user fee funded programs. FDA was also directed to “continue select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.”

However, the guidance noted that FDA will be “unable to support the majority of its food safety, nutrition, and cosmetics activities. FDA will also have to cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.”

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