Drugs

More Evidence of Political Meddling in Coronavirus: Subcommittee

The House Select Subcommittee on the Coronavirus Crisis says it has uncovered additional evidence of Trump administration political meddling in coronavirus guidance, testing, and treatments. In a statement (contains links to documents and letters), subcommittee chairman James Clyburn (D-SC) says the Trump administration:

pressed FDA commissioner Stephen Hahn to approve hydroxychloroquine and convalescent plasma over the objections of scientists;
weakened CDC guidance to hide positive tests while promoting reopening; and
manipulated public health information.

Clyburn says that as part of the subcommittee’s continuing investigation, letters were sent to Biden administration chief of staff Ronald Klain and HHS acting secretary Norris Cochran seeking additional documents and information on the Trump administration’s political interference with the nation’s public health response.

“These document requests are necessary,” the statement says, “because the Trump administration repeatedly obstructed the Select Subcommittee’s investigations, even after chairman Clyburn issued subpoenas to then-HHS secretary Alex Azar and then-CDC director Robert Redfield in 12/2020.”

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