Drugs

WLF Asks Supreme Court to Overturn 3rd Circuit Decision

Washington Legal Foundation (WLF) has asked the Supreme Court to overturn a 3^rd Circuit Court of Appeals decision in Pfizer v. Rite Aid Corp because the decision dramatically expands antitrust law and prevents settling of patent litigation. WLF says the 3^rd Circuit decision requires exacting antitrust scrutiny for virtually any agreement between a branded drug company and a generic company to settle patent infringement litigation.

The filing notes that the Supreme Court held in 2013 in Actavis that patent litigation settlements are subject to antitrust scrutiny if the settlement includes a large and unexplained cash payment from the innovator company to the generic company. It held that such payments may be an indication that the innovator company is unreasonably restraining trade by paying a potential competitor to stay out of the market.

WLF says the 3^rd Circuit dramatically expanded that ruling by holding that any benefit provided by the innovator company, even an agreement to compromise a damage claim asserted in pending litigation, triggers antitrust scrutiny.

“Settling lawsuits ought to be encouraged,” said WLF chief counsel Richard Samp, “because it is more economically efficient than trials and saves judicial resources. Yet, the appeals court’s misguided application of antitrust law in this case will render it virtually impossible to settle drug patent litigation.”

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