Drugs

Supreme Court Rejects Lawyers’ Risperdal Appeal

The Supreme Court has refused to hear the appeal of a Philadelphia law firm that wanted FDA to either withdraw its approval for use of Janssen’s Risperdal (risperidone) in children or require a Boxed Warning about the potential for side effects including gynecomastia. FDA rejected the petition from Sheller P.C., which then filed suit in a Pennsylvania federal court. When that court held that the firm lacked legal standing to challenge the agency, Sheller appealed to the Third Circuit Court of Appeals, which upheld the lower court ruling. The Supreme Court’s decision allows the appeals court decision to remain in place.

A Bloomberg Life Sciences Law & Industry Report story says that generally third parties without a direct, personal stake in the matter being considered can’t sue the government, although courts have allowed third parties to sue in certain circumstances, such as when the third party is a guardian for a child in a lawsuit.

The Sheller firm has filed several product liability suits on behalf of children who took branded and generic risperidone and the related drug paliperidone and had adverse experiences. Firm founding partner Stephen Sheller criticized the high court’s decision as “a sad commentary. We don’t have standing to protect these children and there are thousands of them. The law needs to change.”

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