FDA Policy/General

Alliance: Budget Blueprint ‘Dead on Arrival’

FDA watchers are calling President Trump’s budget blueprint, which includes a doubling of user fees (see story), “dead on arrival,” according to an Alliance for a Stronger FDA analysis. During a 3/22 hearing, lawmakers expressed concern of the blueprint’s discussion on increasing user fees.

“This Congressional reaction is not surprising,” the Alliance notes. “Past user fee agreements have always been accepted by Congress on the basis that they represent a widely-acceptable quid pro quo based on lengthy and highly nuanced negotiations. This year’s reauthorization was destined to have the same treatment and probably will. Barring some quite unforeseen twist or turn, Congress seems likely to adopt the user fee agreements covering FY 18-22 at the agreed-upon funding levels and not include the substantial increment requested by the Trump Administration.”

The Alliance says that appropriations committees need to hear from the FDA stakeholder community that cuts to FDA’s budget authority appropriation will put the American people at risk and undercut the goal of promoting innovation in medical products and food.

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