Drugs

Court Denies Summary Judgment in Teva Whistleblower Case

A New York federal judge has denied a Teva motion for summary judgment in a whistleblower case over speakers bureau promotion of two of its drugs. In the case, former Teva sales representatives allege that the speaker program for the firm’s Azilect (rasagiline) tablets, a Parkinson’s disease drug, and Copaxone (glatiramer acetate injection), which treats relapsing-remitting multiple sclerosis, was a conduit through which prescribers were bribed with speaker fees, expensive meals, and alcohol in exchange for prescribing the drugs.

The company petitioned the court to grant it summary judgment because (1) the whistleblowers did not raise an issue of material fact that Teva committed an anti-kickback violation through its speaker program; (2) the whistleblowers failed to link any purported anti-kickback violations to the prescription reimbursement claims that form the basis for their False Claims Act actions; and (3) the whistleblowers have failed to offer any evidence that any misrepresentation about anti-kickback compliance was material to the government for the purposes of the False Claims Act.

The court rejected all three of the company’s articles and said the case may proceed to trial.

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