Drugs

Fresenius Decision to Abandon Akorn Deal Based on ‘Blatant Fraud’

A Fresenius decision last month to terminate the company’s $4.7 billion merger agreement with generic drug company Akorn was based on alleged “blatant fraud at the very top level” at Akorn, Fresenius said in a recent court filing. Last month, Fresenius said its decision was based on, among other factors, “material breaches of FDAdata integrity requirements relating to Akorn’s operations found during Fresenius’ independent investigation.” Fresenius offered to delay its decision in order to allow Akorn additional opportunity to complete its own investigation and present any information it wished Fresenius to consider, but Akorn had declined that offer.

According to a Reuters report, Akorn said in its lawsuit that Fresenius uncovered data integrity problems that are common in the generic drug industry and is using the concerns to cancel the transaction. “But Fresenius alleged that an Akorn executive vice president for quality assurance, whose name was redacted from the court filing, knowingly directed the submission of fraudulent testing data to the U.S. Food and Drug Administration,” the report said. The alleged fraudulent data involved an application to market Akorn’s antibiotic azithromycin, and Fresenius alleged the fraudulent scheme began in 2012. Fresenius also alleged that “the same scheme has infected” at least five other Akorn products.

Akorn has said in court documents it investigated the possible submission of falsified data and fired an executive who was involved. “Critically, azithromycin and the five other drug products in question either have never been marketed or are not currently being marketed and were never forecasted to form a material portion of Akorn’s future earnings,” the company said in one of the documents.

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