FDA Policy/General

Merit Medical Paying $18 Million to Resolve Kickback Case

The Justice Department says Merit Medical Systems, South Jordan, UT, has agreed to pay $18 million to resolve allegations that it caused the submission of false claims to government healthcare programs by paying kickbacks to doctors and hospitals to induce use of its products. A department statement says the company provided millions of dollars of advertising and other marketing support to healthcare providers to induce the sale of its products.

The statement says that while Merit said its Local Advertising Program was designed to increase awareness of medical treatments, it allegedly assisted only selected providers to reward past sales, induce future sales, and steer business to the company and away from its competitors.

The government says that Merit disregarded numerous warnings that its conduct could violate the anti-kickback statute, including warnings from its former chief compliance officer. The officer filed a whistleblower complaint and will receive $2.65 million from the settlement.

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