Drugs

Novartis Settles Elidel False Claims Case

Novartis reportedly has paid over $35 million to settle a whistleblower’s false claims case over off-label marketing of its eczema cream Elidel. Corporate Crime Reporter says that a former Novartis sales representative alleged that he was instructed to tell doctors that Elidel was safe and effective for use on infants. The approved FDA indication is for treating eczema in patients older than age two when conventional therapy is ineffective or not advisable, and only for short-term use. According to the story, animal studies suggested that Elidel could cause skin cancer and non-Hodgkin’s lymphoma and FDA specifically refused to approve it for use on infants younger than 24 months.

The former sales rep also alleged that the company violated federal and state anti-kickback laws by paying doctors to attend lavish dinners and conferences where off-label Elidel uses were advocated.

In 2004, the article says, FDA convened a pediatric drugs advisory committee to study the cancer risk and ended up requiring a Boxed Warning in the drug’s labeling.

The sales rep has received 29% of the money recovered for the federal and state governments through his suit. He also filed a separate Texas case based on the off-label marketing of Elidel because that state has its own whistleblower law. That case was settled for $19 million in damages and fees, bringing the total recovered for federal and state taxpayers to more than $54 million, the article says.

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