Drugs

SCOTUS Should Hear Label Highlights Appeal: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) is asking the Supreme Court to hear an appeal from the 11th Circuit Court of Appeals that involves the potential for state tort-law liability if drug companies fail to unilaterally change language in the Highlights section of prescription medicine labeling. In its amicus brief, PhRMA says the question has substantial interest to its members since FDA prohibits companies from making such unilateral changes to labeling language.

“The burdens of product liability litigation are already substantial for life sciences companies,” PhRMA says, “and a regime that permits these companies to be held liable for failing to do what FDA forbids them from doing would disrupt regulation, hamper innovation, and harm patient health.”

The brief says the 11th Circuit erred in allowing the case of Shire v. Mark Blackburn to proceed on the theory that Shire could have made a change to the Highlights section of labeling for its ulcerative colitis drug Lialda (mesalamine) through the changes being effected provision. “The 11th Circuit’s decision undermines FDA’s authority to control the content of medicine labeling and at the same time places manufacturers in the impossible position of facing civil liability for failing to unilaterally revise the Highlights section, an action that FDA has explicitly forbidden manufacturers from taking,” PhRMA declares…. “The 11th Circuit’s ruling has the effect of creating a patchwork system of liability that will ultimately hamper manufacturer innovation and harm patient health. The decision of the 11th Circuit should be reversed.”

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