Drugs

AstraZeneca Settles Texas Medicaid Suits for $110 Million

Texas attorney general Ken Paxton says that AstraZeneca has agreed to pay the state $110 million to settle suits alleging that the company falsely and misleadingly marketed Seroquel and Crestor in violation of the Texas Medicaid Fraud Prevention Act. In a statement, Paxton says the company was accused of engaging in false and misleading marketing schemes at a time when it was under the strict obligations of a 2010 federal corporate integrity agreement resulting from prior allegations of Medicaid fraud. Although that agreement prohibited AstraZeneca from promoting Seroquel and Crestor for uses not approved by FDA, Paxton says, the company continued its off-label marketing.

The company was accused of marketing Seroquel to Medicaid providers who primarily treat children and adolescents when the drug was not approved as safe and effective for that population. Paxton’s office accused AstraZeneca of making hundreds of thousands of dollars in illegal payment to two former state hospital doctors to unduly influence the use of Seroquel in the state hospital system.

The company was also accused of a similar nationwide marketing fraud scheme involving Crestor, including allegations that it executed a plan of deception targeted directly at Texas Medicaid to expand the use of the statin beyond what the science supported, while downplaying a significant risk of diabetes in certain patients.

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