Drugs

Senators Ask CMS Not to Hurt Alzheimers Drug Access, Research

Sens. Susan Collins (R-ME) and Shelley Capito (R-WV) are asking the Centers for Medicare and Medicaid Services (CMS) to ensure that its national coverage determination on Biogen’s Aduhelm (aducanumab) and other monoclonal antibody Alzheimer’s drugs does not restrict access and impede research into the disease. In a statement (includes link to letter to CMS), the senators say CMS had a wide range of coverage decisions it could make and chose “a particularly burdensome and restrictive approach that could sharply curtail access not just to one approved product, but to an entire class of potential future products still in the development pipeline It is highly unusual, if not precedent-setting, for CMS to attempt to evaluate a drug’s clinical benefit. Congress has reserved this task for FDA, which said that Aduhelm’s effect on cognition was nough to merit accelerated approval pending confirmation of the clinical benefit.”

The senators say the CMS coverage decision would restrict access to the entire class of therapies to only those patients who can participate in a CMS-approved clinical trial or those who can afford to pay out-of-pocket.

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