FDA Policy/General

Budget Draft Nixes Trump’s Request to Double User Fees

The House Appropriations Committee has released a draft bill covering FDA’s fiscal year 2018 budget that dismisses the Trump Administration’s request to double industry-funded user fees. Under the draft, the agency would receive a total of $2.8 billion in discretionary funding, which is equal to the fiscal year 2017 enacted levels. Total funding for FDA, including revenue from the recently renegotiated user fee agreement, is $5.2 billion — $490 million (10%) above fiscal year 2017. The draft will be marked up 6/28 by the Agriculture Subcommittee.

Food safety activities are supported in the draft by more than $300 million, and $60 million would be allocated to the 21^st Century Cures Act activities. Language has been added to allow FDA to receive transfers from the National Institutes of Health for support of the agency’s Oncology Center of Excellence.

Responding to the draft, the Alliance for a Stronger FDA said it is “grateful that the House has retained the agency’s FY 17 funding base and supported previously agreed upon bipartisan user fee agreements that are reflected in the House and Senate versions of the FDA Reauthorization Act (FDARA) legislation. We look forward to continued fruitful discussion with the appropriations committees about FDA’s increasing responsibilities, including the costs of meeting new non-user fee activities contained in the FDARA legislation. 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