Drugs

Bayer Paying $40 Million to Settle 2 Whistleblower Suits

The Department of Justice (DoJ) says Bayer has agreed to pay $40 million to resolve two whistleblower suits alleging violations of the False Claims Act in connection with the drugs Trasylol, Avelox, and Baycol. The whistleblower suits were filed and pursued for almost two decades by former Bayer marketing employee Laurie Simpson. She will receive about $11 million from the settlement, the department says.

The DoJ says Simpson first filed a suit alleging that the company paid kickbacks to hospitals and doctors to induce them to use Trasylol and Avelox and also marketed the drugs for off-label uses that were not reasonable and necessary. She also said Bayer downplayed Trasylol’s safety risks.

Simpson’s second suit said Bayer knew about, but downplayed, Baycol’s risks of causing rhabdomyolysis and that the company misrepresented the drug’s efficacy when compared to other statins.

Trasylol and Baycol have been removed from the market for safety reasons, the DoJ says.

Bayer will pay $38,860,555 to the federal government and $1,139,445 to 20 states and the District of Columbia.

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