FDA Policy/General

Why Tobacco Detracts from FDA’s Budget Case

Medical product user fees account for 38% of FDA’s funding, but when you add tobacco user fees, which fund 100% of the agency’s tobacco-related programs, they raise the overall user fee percentage to 47%. The tobacco fees skew the budget numbers and may detract from legitimate budget arguments when appropriators look to finalize the taxpayer-funded budget authority (BA) numbers each year, suggests the Alliance for a Stronger FDA in its weekly update.

The Alliance says it always calculates using FDA’s total non-tobacco budget, which for the coming fiscal year is likely to be $4.474 billion. “Our rationale is two-fold,” the advocacy group says. “First, tobacco control programs at FDA were created because of industry user fees and are totally funded by them. The programs have never been premised on taxpayer funding. Second, when FDA funding is characterized by BA vs. user fees, it is food and drug programs that the listener is thinking about, not tobacco. If you include tobacco user fees, they skew the numbers and distort what people really want to know (some variant of: how much do medical product companies contribute to FDA’s programs).”

So, the 9% shift (48% vs 38%) in user fee reliance from adding tobacco fees “exemplifies why including them does not provide an accurate picture,” the Alliance says.

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