Drugs

Government Shutdown Likely This Weekend

As of Friday (9/29) evening, the ongoing Congressional budgetary impasse is on course to trigger a government shutdown this weekend. House Speaker Kevin McCarthy seems to lack the necessary votes to pass a short-term continuing resolution to keep government agencies like FDA fully running after 9/30 while negotiations continue.

“Today and over the weekend, there will be strenuous efforts to find Congressional agreement on short-term funding to avoid a government shutdown,” the Alliance for a Stronger FDA said in a 9/29 statement. “The situation is fluid and we hope for a speedy agreement. However, immediate resolution is unlikely and a shutdown seems inevitable. About 80% of FDA’s existing staff will be working if there is a shutdown. FDA’s leadership will be responsible for triaging available personnel and funds to ensure that the highest priority activities continue to be supported for as long as possible.”

The Alliance says that during any “lapse period, there are limited activities in which the agency can operate.” It says the “activities that the agency can perform include: (1) activities necessary to address imminent threats to the safety of human life and (2) activities funded by advanced and carryover funds, notably but not exclusively, user fees.”

The group believes that there are sufficient carryover balances to continue user fee-related activities for quite some time, but if the shutdown is prolonged then this would present a problem and user fee staff could face furloughs. During the last shutdown, about 41% (7,053) of employees were furloughed. However, the current HHS plan for a shutdown projects FDA furloughs of about 19% (3,658) of employees.

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