Drugs

SCOTUS Changes ‘Impossibility Preemption’ Landscape

A 5/20 Supreme Court decision in a Merck Fosamax case involving the company’s alleged failure to warn about atypical femur fractures “will change the dynamics of litigation involving the impossibility defense, and will introduce new litigation uncertainty due to a shift in the decision maker for impossibility preemption.” That’s the view of attorney Ethan Townsend (McDermitt Will &Emery) writing in a blog post.

Townsend says the high court unanimously reversed a 3^rd Circuit Court of Appeals decision that held that the “clear evidence” standard enunciated by the Supreme Court in 2009 in Wyeth v Levine was a factual burden of proof for a jury to decide. The high court in the Fosamax case said the question of whether there is clear evidence that FDA would have rejected a proposed labeling change was a question of law for a judge to decide.

The post says there were differences in the justices’ reasoning, even though the decision was unanimous. As a result, Townsend writes, questions still remain. One such question is whether a manufacturer must use the “changes being effected” (CBE) process whenever it wants to make a labeling change in hopes of preserving the impossibility preemption defense. He says the court’s opinion does not go that far, only stating that because of the CBE process, manufacturers will not “ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.”

According to Townsend, it seems possible, if not likely, that many lower courts will simply default to a bright-line rule that requires manufacturers to use the CBE process, and for FDA to thereafter disapprove the label warning alleged to be required by state law, to successfully invoke the impossibility defense.

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