Drugs

Trump’s ‘Dangerous’ Meddling at FDA and CDC

President Trump and his administration’s “meddling for political purposes” in FDA and CDC activities related to Covid-19 puts the nation at risk, warns a Washington Post editorial board opinion piece. The Post looks at Trump’s touting of hydroxychloroquine and the expanded use of convalescent plasma as examples of overreaching. Recently, the administration has “manipulated” CDC’s scientific reports to meet Trump’s political narratives. HHS assistant secretary for public affairs Michael Caputo and his scientific advisor Paul Alexander reportedly demanded changes to CDC’s reports. When word of the interference got out, Caputo put in a 60-day medical leave request after having a bizarre meltdown on Facebook, and Alexander has left HHS altogether.

Such interference could “misinform the public and distort policy decisions,” the opinion piece says. “Worst of all, it could lead people to lose faith in these public health agencies, cascading into dangerous distrust of a vaccine or drug therapy. It is hard to see the political profit in that.”

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