Drugs

Rep. Guthrie to Chair FDA Oversight Committee

Representative Brett Guthrie (R-KY) has been selected to serve as the House Energy and Commerce Committee’s Health Subcommittee chair for the current 118th Congress. The subcommittee has primary oversight of FDA and other health agencies. “My goal is to have a productive Health Subcommittee this Congress to ultimately help Americans live healthier and longer lives,” he said in a statement. “That starts with combating the overdose epidemic, making health care more affordable, and increasing the development of and access to life-saving treatments.

“With a Republican House majority,” he continued, “a new wave of oversight and accountability in health care is coming for the Biden Administration to improve health care agencies and prevent future crises. I look forward to working with Energy and Commerce Committee chair Cathy McMorris Rodgers and my colleagues to deliver solutions that empower patients and modernize health care.”

Nine days ago, Guthrie introduced the Pandemic is Over Act, a bill to end the Covid-19 public health emergency (PHE). “The Covid-19 pandemic is over,” he announced in a 1/17 news release. “Despite President Biden admitting this in September, his administration just authorized the 12th extension of the Covid-19 public health emergency. It is long overdue for President Biden to end the Covid-19 public health emergency and relinquish the emergency powers that he just renewed again. President Biden’s inaction and lack of transparency on this are unacceptable. I introduced the Pandemic is Over Act to prevent any more delays by forcing the Biden Administration to finally release and execute a plan that my House Republican colleagues and I have been repeatedly pressing for to unwind the PHE.”

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