Drugs

SCOTUS Should Hear Janssen Preemption Case: Column

The Supreme Court should hear the appeal of a Janssen case in which the Philadelphia Court of Common Pleas held the company liable for not adding warnings about specific risks of off-label uses associated with one of its drugs. That’s the view of American Tort Reform Association president Tiger Joyce. Writing in a Bloomberg Law online column, Joyce says the high court should take the opportunity to make it clear that state courts cannot hold any party liable for simply following guidelines set forth by federal agencies.

Joyce says the Philadelphia court decision, which the Pennsylvania Supreme Court declined to review, ignored the fact that FDA prevents companies from unilaterally making changes to labeling. “FDA has the power and statutory obligation to ensure that prescription medicine labels appropriately communicate risks from off-label uses,” Joyce writes. “FDA experts know how to best convey the information without diluting the labeling by including speculative or scientifically unfounded warnings.”

Joyce argues that as a practical matter, a state court holding the manufacturer of an FDA-approved product liable for not changing a mandated warning has the effect of overruling federal law. “If allowed to stand, it would, we believe, violate the Supremacy Clause of the U.S. Constitution,” he says.

Allowing such legal inconsistency and unpredictability would impair innovation and investment in the development of new treatments, according to Joyce, because businesses would be exposed to 50 different state regulatory and liability structures.

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