Drugs

Fraud, Abuse Landscape Changing: Review

The Bass Berry & Sims 2015 Healthcare Fraud and Abuse Review says that only a fraction of the $3.6 billion in Fiscal Year 2015 civil fraud recoveries involved matters concerning the drug industry, while a significant amount of them involved whistleblower actions raising issues of medical necessity and improper financial relationships between hospitals and doctors. This was the 11^th straight year in which recoveries exceeded $1 billion, the report says.

It notes that the year’s fraud headlines were noteworthy as much for legal developments and Justice Department pronouncements as for the healthcare fraud recovery amount.

Although 2015 was the fifth straight year in which whistleblowers filed more than 600 new lawsuits, the yearly total of 632 new suits was more than 10% lower than in the previous year. Whistleblowers recovered a record-breaking $598 million as their share of the proceeds in qui tam judgments and settlements in FY 2015.

The report also references the 9/2015 “Yates Memo” in which deputy attorney general Sally Yates formalized a message that department officials have forecasted for several years: that it will seek to hold individuals who are responsible for corporate wrongdoing accountable for their actions.

Details in the report cover a number of cases involving FDA.

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