Drugs

Novartis Loses Summary Motion in Kickback Case

A New York federal judge has denied a Novartis motion for summary judgment in a whistleblower case alleging a decade-long company-wide kickback scheme through which the company paid doctors honoraria and other forms of remuneration for taking part in purportedly educational promotional programs to induce doctors to prescribe the company’s drugs. The judge granted a federal government motion for partial summary judgment.

A 3/31 court order says Novartis argued that: (1) the government did not offer particularized evidence of a nationwide kickback scheme and impermissibly relied on “expert-created markers” to prove such a scheme; (2) the government seeks to hold Novartis liable for conduct that was resolved in a 2010 settlement agreement between Novartis and the Justice Department; and (3) the government cannot establish causation for either liability or damages under the False Claims Act.

The court held that: (1) the government provided sufficient particularized evidence of a company-wide kickback scheme, and the expert-created markers, criteria indicating that a promotional event lacks a medical educational purpose or value, are admissible evidence of such a scheme; (2) the settlement agreement does not release Novartis from claims concerning any drugs not listed as “covered drugs” in the agreement; (3) the government has offered sufficient proof of the company’s liability to survive summary judgment and has offered sufficient proof of resulting harm; and (4) the government may include new claims relating to “lunch-and-learns” in its case.

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