FDA Policy/General

Alliance Urges $120 Million Boost for FDA Budget

Alliance for a Stronger FDA has urged Congressional appropriators to bump up FDA’s proposed FY 2017 budget request by $120 million (4%) in order for the agency to carry out its responsibilities. The request would increase FDA’s budget, not including user fees, to $2.85 billion.

The Alliance has been very vocal about how disappointed it is with the Obama Adminstration’s 2/9 budget proposal of $2.74 billion, a 0.5% ($15 million) increase over last year’s budget (see story). “We are alarmed that the proposed budget will require FDA to choose among competing public health priorities, which is counter to the national interest and poorly serves the health and safety of the American people,” the group said in a statement at the time. It noted that the foods center would receive a $26 million increase, offset by flat or lower spending on other centers and a decrease in appropriations support for rent payments.

The Alliance offered this rationale for seeking an increased FDA budget: “FDA’s broad and far-reaching responsibilities continue to expand annually. The agency’s larger needs emanate from legislative requirements, increased complexity of science, globalization and homeland security and emerging infectious disease activities (which includes the Ebola and Zika viruses). Specifically, the Alliance proposes funds to be used to: (1) carry out a number of medical product initiatives, such as biosimilars, drug compounding, and regulatory science (e.g. validating biomarkers, post-market surveillance) and (2) incrementally fund implementation of food safety activities. Also, FDA needs the tools, including effective planning, to continue to manage its growing responsibilities. ”

The Alliance is asking its members to contact House and Senate lawmakers to urge the higher funding limit. Appropriators have set a mid-March deadline for other lawmakers to submit additional funding requests.

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