Drugs

‘Skinny Label Effectively Dead’: Attorney

Attorney Sara Koblitz (Hyman, Phelps & McNamara) says the generic carve-out “skinny label” may be effectively dead for any risk-averse generic drug sponsors thanks to a recent Federal Circuit Court of Appeals decision. Writing in her firm’s FDA Law Blog, Koblitz says the generic drug industry is anxiously waiting to see whether Congress or the Supreme Court can revive the skinny label.

While they wait, she says, innovator drug companies are filing more induced infringement suits.

The Federal Circuit, sitting en banc, affirmed an earlier three-judge ruling that Teva’s sale of generic carvedilol induced infringement of a GlaxoSmithKline method-of-treatment patent for Coreg. The court indicated that the inducement liability was due to Teva’s additional marketing activity that encouraged others to infringe.

“While the majority opinion may be limited in this case with respect to the specific way the court found inducement infringement,” Koblitz writes, “it nonetheless upends the industry. This decision raises just as many questions as the last, which can be seen from the follow-on cases that already are in progress in the courts.”

She spends much of her analysis reviewing the “vehement” dissent filed by Federal Circuit Chief Judge Sharon Prost. Prost reviewed the many questions she says are raised by the majority opinion.

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