Drugs

Judge Doesn’t Toss Whistleblower Suit for 1st Amendment

A Pennsylvania federal judge has ruled that Sanofi Aventis can’t cite the 1^st Amendment as grounds for dismissing a whistleblower’s suit charging that it used fraudulent and misleading speech to promote its chemotherapy drug Taxotore. An online blog post by attorneys for Peitragallo Gordon says that the company also sought to have the suit dismissed because some of its claims were barred by the statute of limitations.

The court held that the company had been given fair notice of the claims when the whistleblower filed his first and second amended complaints. In terms of the 1^st Amendment, the company said that free speech protections extend to commercial speech and that parts of the whistleblower’s claims were based on truthful, non-misleading speech. The judge said that the complaint asserted that the company’s off-label promotion of Taxotore as useful for more than its approved second-line treatment indication was false and misleading, and the dispute over whether the speech was truthful or false was best determined by a jury.

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