FDA Policy/General

Gottlieb’s Goodwill on Hill Called ‘Incalculable’

FDA commissioner Scott Gottlieb has made a big hit on Capitol Hill among both Republicans and Democrats and this bodes well for the agency’s budget appropriations, according to the 180-member Alliance for a Stronger FDA. Reporting to members on the alliance’s 60-office 4/25 “Advocacy Day” on Capitol Hill, deputy executive director Steven Grossman said one thing they kept hearing was “how pleased Congress is with Dr. Gottlieb. We found this in both Republican and Democratic offices. Many of the staffers reported that their Member had met the commissioner at hearings, briefings, visits and in-district events. Their bosses find him responsive and thoughtful. The goodwill he is generating for the agency is incalculable.”

Grossman’s analysis was headed “Off to a Great Start” and alluded appreciatively to the President’s 2019 FDA budget request for a 13% increase, saying it “recognizes that there are multiple opportunities for FDA to be a more effective protector of the public health, as well as a fairer and more efficient regulator. We are at a point where additional investment in FDA will result in substantial added value to the American public.”

However, Grossman wrote, despite FDA bipartisan support on the Hill, “we can’t assume that this will be enough to win the day. We still expect it will be a hard fight — dollars to pay for FDA are going to be scarce — but we couldn’t hope to start from a better position.”

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