Drugs

FDA Alliance Lobbies for $78 Million Budget Boost for FDA

Alliance for a Stronger FDA has completed its annual agency budget analysis and has determined FDA needs $2.8 billion or 3% ($78 million) more in FY 2018 than the amount appropriated in FY 2016 and available to the agency under the FY 2017 continuing resolution. The 3% increase is separate and apart from another $60 million in “off-budget monies” that the Alliance is hopeful will be available to FDA to implement specific provisions of the 21st Century Cures legislation.

Now that HHS secretary Tom Price is in office, the Alliance speculates that he is focused on repeal of the Affordable Care Act (Obamacare), and there appears to be little, if any, interest in FDA at the moment. “Within the next few weeks, we expect the appointment of a deputy secretary of HHS, which is a Senate-confirmable position,” the group says. “Only after that occurs do we expect that there will be announcements about leadership for agencies within HHS, notably FDA commissioner. For comparison purposes, in 2009, Dr. Hamburg was nominated mid-March and was confirmed by mid-May.”

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