Drugs

Report Analyzes False Claims Act Enforcement Developments

A Hogan Lovells white paper, “The False Claims Act Guide: 2020 and the Road Ahead,” says that a federal directive to prioritize the investigation of coronavirus-related fraud, the unprecedented amount of federal stimulus payments, and the transition to a new administration are creating a climate in which False Claims Act (FCA) enforcement likely will create significant risks for businesses in 2021. The report looks at FCA enforcement trends in industries including healthcare, financial services, and higher education, as well as key developments in the law that are expected to drive FCA enforcement this year, according to a firm statement.

The report’s executive summary says the Justice Department continued a sustained program of FCA enforcement in 2020 leading to significant judicial decisions on issues of increasing importance in FCA jurisprudence and the recovery of substantial damages and penalties in settlements under the act.

“In particular,” it says, “the healthcare sector continued to see nine-figure FCA settlements stemming from anti-kickback statute violations and billing for medically unnecessary services, but the year also saw substantial FCA settlements as part of the government’s priority in combatting the opioid epidemic.”

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