Drugs

FTC Appeals Shire Vancocin Case Dismissal

The Federal Trade Commission (FTC) is appealing to the 3^rd Circuit Court of Appeals a Delaware federal court decision granting a Shire motion to dismiss an FTC suit alleging that the company abused the FDA citizen petition process to prevent generic competition to its Vancocin. Attorney Jennifer Thomas (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that in appealing the decision to the 3^rd Circuit, the FTC is saying that it will not amend its original complaint as the Delaware federal court had said it could do.

“Rather,” she writes, “the FTC will risk abandoning its case in district court in favor of seeking a review of the key legal issue by the 3^rd Circuit. This speaks to the significance of the lower court’s ruling that the FTC had failed to meet its statutory burden in bringing the case—the Shire ruling has already been cited against the FTC in at least four other pending cases.”

The district court judge held that the FTC’s ability to seek an injunction in the case rested on the agency’s ability to demonstrate that the company had violated or was about to violate a law that FDA enforces. He also held there was no dispute that the FTC had not alleged that Shire was violating a law.

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