Drugs

FDA ‘Rewrites’ History, Facts in Coreg Label Case: GSK

Responding to a government amicus brief supporting the generic drug industry and asking the Supreme Court to hear an appeal of the so-called “skinny label” case brought by GlaxoSmithKline against Teva over labeling for a generic form of GSK’s heart drug Coreg (carvedilol), GSK says the government doesn’t address the facts of the case and the documented history of the carveout process and instead “rewrites both to reach the result it wants.” The Glaxo brief urges the high court not to accept the appeal “on such false premises, which will lead to messy merits proceedings dominated by factual disputes, making this case a poor vehicle for addressing the issues raised by the government.”

The government’s brief said the legal question is: If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages the infringement of the carved-out uses.

In its latest brief, Glaxo stated the question as: When a generic drug is doubly indicated for a patented use, and there is strong record evidence of intent and inducing content, can the generic manufacturer evade liability for induced patent infringement merely because it did not include on its label (i.e., “carved out”) one of the two indications corresponding to the patented use.

Glaxo said a properly-instructed jury found Teva wilfully intended to cause infringement with its skinny label and that finding was upheld by the Federal Circuit Court of Appeals.

The Supreme Court doesn’t have to rely on GSK’s, Teva’s, or the government’s word on any of the factual matters, Glaxo’s brief says. It says a supplemental proceeding on remand is already slated to address these questions in the context of a Teva defense. “The government attempts to short-circuit this process by resolving contested issues against GSK and dispensing with evidence and law that does not fit its policy objectives,” Glaxo says. “This is no basis for recommending a grant of certiorari. The petition should be denied.”

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

Read more

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