FDA Policy/General

Flat FDA Budget Moves Through Senate Subcommittee

The Senate Agriculture Appropriations Subcommittee has approved $2.8 billion in discretionary funding for FDA for fiscal year 2018, which is $1 million over the FY 2017 enacted level. Overall, total FDA funding, including user fee revenues, is $5.2 billion, which is $491 million above FY 2017. Like a similar version advancing in the House, the spending bill does not support new user fees or the associated cuts to budget authority as proposed in the president’s budget request. The bill now moves to full committee for consideration. Late last month, the House Appropriations Subcommittee on Agriculture/FDA advanced to the full committee its version of an FDA funding bill that provides almost $2.8 billion in direct budget authority (see story).

The Alliance for a Stronger FDA applauded the FDA funding plan. “Despite an exceedingly difficult funding environment, the House subcommittee has, in effect, said: FDA performs essential services and cannot fulfill its responsibilities without resources at least as great as the agency had in FY 17,” said Alliance President and National Kidney Foundation vice president for government relations Troy Zimmerman. “A strong FDA — capable of fulfilling its broad mission — is a critical component of our nation’s health and safety.”

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