FDA Policy/General

FDA, CDC Have Lost Bill Gates’ Trust

Former Microsoft CEO Bill Gates says FDA and CDC are casualties of the Donald Trump presidency that has downplayed or dismissed science and medicine in the pursuit of political gain. Interviewed by Bloomberg Television, Gates cited FDA commissioner Stephen Hahn’s rapid about-face on the benefit of convalescent plasma as a Covid-19 treatment.

“We saw with the completely bungled plasma statements that when you start pressuring people to say optimistic things, they go completely off the rails,” Gates said. “FDA lost a lot of credibility there. Historically, just like CDC was viewed as the best in the world, FDA had that same reputation as a top-notch regulator. But there’s been some cracks with some of the things they’ve said at the commissioner level.”

Bloomberg says Gates is having to put his faith in the companies working on Covid-19 treatments and vaccines rather than in the regulators.

“These companies are very professional and the benefits of the vaccine here are very dramatic,” Gates said in response to a 9/8 pledge by nine of the drug companies to put science and ethics first, prioritizing safety over speed in the development of any vaccine they submit for emergency approval. While acknowledging that side effects are always possible, Gates said he expects a safe vaccine to come out of the development effort.

He applauded the government’s investment of billions of dollars to secure U.S. vaccine supplies under Operation Warp Speed but said he’s frustrated by lack of government funding for manufacturing and procurement in the developing world. He said that by spending an additional $8 billion to $10 billion on global vaccinations, the U.S. would save “trillions” in lost economic output, as well as saving lives and livelihoods. And that would also help prevent the Covid-19 virus from reemerging in wave and wave of infection, he said.

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