Drugs

Grassley, Wyden Push Drug Price Overhaul Bill

The Senate Finance Committee meets 7/25 to mark up the Prescription Drug Pricing Reduction Act of 2019, introduced by committee chairman Chuck Grassley (R-IA) and ranking member Ron Wyden (D-OR). Grassley and Wyden say the bill as drafted would result in Medicare savings of $85 billion over 10 years, beneficiary savings of $27 billion in out-of-pocket costs, beneficiary savings of $5 billion in premiums, Medicaid savings of $15 billion, and savings for prescription drug benefits offered by commercial insurers.

“The cost of many prescription drugs is too high,” Grassley and Wyden say. “Without action, we’re on an unsustainable path for taxpayers, seniors, and all Americans…. We’ve been working on a bipartisan basis for more than six months to craft legislation that begins to address the broken prescription drug supply chain…. This legislation shows that no industry is above accountability. Passing these reforms, especially those that will affect some of the most entrenched interests in Washington, is never easy. But Americans are demanding action and reform is long overdue. We’re looking forward to working with our colleagues on the Finance Committee and with other committees in Congress to pass this prescription drug pricing overhaul very soon.”

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