Drugs

Could SCOTUS Eliminate ‘Levine’?

Writing online for Drug & Device Law, attorneys Dick Dean and Emmanuel Sanders (Tucker Ellis) speculate whether recent changes in personnel on the Supreme Court could bring an end to Wyeth v. Levine, the case that held that a jury can second-guess whether an FDA-approved label is adequate. “It should first be noted,” the two write, “that there is little left of this decision given the fact that courts now determine the ‘newly acquired information’ and ‘clear evidence’ issues as a matter of law. But under Levine a jury still decides adequacy if there are any open issues after the aforementioned legal issues are adjudicated.”

In Levine, the attorneys write, justices Alito, Roberts, and Scalia dissented, finding that permitting juries to second-guess an FDA Warning decision would frustrate the purposes and objectives of FDA. This is known as the “obstacle preemption.”

For the future, the attorneys see justices Alito and Roberts as likely votes to overturn Levine, potentially joined by justices Gorsuch, Kavanaugh, and Barrett.

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

Read more

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