Drugs

Gottlieb Approved by Senate as Next FDA Commissioner

The Senate 5/9 voted 57-42 to approve the nomination of Scott Gottlieb as the next FDA commissioner. The nomination now moves to the White House for an official swearing in. Gottlieb previously served as deputy FDA commissioner during the George W. Bush administration.

“Dr. Gottlieb is the right person to lead the Food and Drug Administration in its vital mission and move the agency forward so that America’s patients benefit from the remarkable discoveries our nation’s researchers are working on,” said Health, Education, Labor & Pensions Committee chairman Lamar Alexander (R-TN). He dismissed concerns about Gottlieb’s previous close ties to industry, noting that an understanding of how drug manufacturers and products move through the regulatory process is “vitally important.”

Opposing Gottlieb’s nomination, Sen. Patty Murray (D-WA) said she was concerned about his ability to avoid conflicts of interest given his unprecedented financial entanglements; his ability to withstand political pressure from the Trump Administration in order to ensure that science, not ideology, drives decision-making at the FDA; and whether or not he will truly prioritize patient and consumer safety and the public’s health over the interests of corporations who stand to gain financially.

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